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Pharmacological treatment of NASH. Where are we?
Elisabetta Bugianesi, Torino
Thursday, Feb. 20, 2020 · 6:05 p.m. · 34m 57s
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really a pleasure and an honour for me to be here it's
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lovely town of the soul pharmacological treatment or nash where we are not
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is it back and simple slides that it's all the
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possible targets uh for the upcoming therapies the off next
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and i take it you're rose the complexity outdated but the genesis of this disease
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because we are not talking about labour disease we are talking about and what i see is that you see that
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sometimes also it's got an i. s. for
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scroll saw that these patients that is cardiovascular disease
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the second is kind so in that because of that that e.
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e. these uh compared to the thirteen in the general population now
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maybe now that this season metabolic i'm reading a disease that uh i know that
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i chose that are very important uh in the onset and progression all night sh
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i notice that type of boxes it generated by cricket yes the meeting believer
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that are coming from and they pose issue which is this action not any
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flying so we also have systemic information
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besides the lever information all these hits uh
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posts fibre janice is within believe ah and saw we go frowned sympathetically
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about associated outside these to see rose these that and do it it's complication
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so in order to target because it's of these liver disease that
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we can target metabolic dysfunction i'm parameter is the injury or we can target for groceries
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now how is nash current to major art is out it
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can incorporate this guideline european could you could incorporate this guideline
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i recommend a lifestyle integration with the weight loss of five to ten percent of initial body weight
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i agree 'cause on thirty to forty five milligram and
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say vitamin e. eight hundred you need a day however
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no no this therapy has been approved by f. d. a. or a
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map and draw on a long time data on these intervention in clinical outcomes
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in da da da da and he map do not recognise simple thirty by as
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a treat to me indication and any new treatment should focus on improving stuart appetite please
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they recommend two mains are a bit targets in next trials
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the first is the is the logical resolution of nations that
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means no ballooning angry zero one information without the worsening of fibrosis
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and the second is intro into infrared roses which is the
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main predict or legal related art can go to worsening of match
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so this is the farce that but actually in the resolution of nash
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fibrosis versa is the force that but for uh getting condition up robot
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but in order to get that meeting approval in
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randomised control trial yeah so you should also demonstrate
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that you can delay or stop the progression just rose is that
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and you can change howard clinical outcomes that are the number of that and also roses complication
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now let's start from that box targeting the top elise
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is is the seminal study uh lights that intervention for
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fifty two weeks in almost a three hundred page shame
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to believe a biopsy before and after the lifestyle intervention
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this is the study that demonstrates that if you achieve more than ten percent a
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weight loss of initial body weights you can achieve a hundred percent state roses improvement
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five a next resolution in ninety percent of cases that in
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fibrosis are greyish on a in at eighty one percent of cases
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so what's the problem the problem is this one like mark twain we used to say
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we're like you saw bowling out call it's better labelled so
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that probably is that just ten percent of the patient start dieting
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we maintain this diet uh and that she just talked
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it uh as the end up all the fifty two week
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and the same as being demonstrated also blackberry of trips archery
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so uh probably you know very well is uh is that
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they where the uh made liver biopsy before and after body out
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surgery and you see that the percentage only bursts your toes is drops from sixty to ten percent
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the novelty activities call or drops from five to one and there is
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also an improvement to offer grows is that these white portion exact zero
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which increases after one year after very out of surgery
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and the uh light grey porsche on r. f. to enter
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free that decreases after one year from the barrio tricks surgery
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but we have also other medication that connect some weight loss
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in particular g. l. p. one agonies that low rider chide
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yeah the one i haven't is to act on weight loss uh by delaying gastric emptying increase in society
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day in progress any control load by increasing
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insulin secretion bloopers degrading some is the creation
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the degrees looker going secretion they have cardiovascular benefits and the decrees labour jane it's it's
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and bizarre results that probably you know better than me these are the results of the lean trial the to use uh
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a fifty two patients randomised to receive one point eighty milligram
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or robert side for for t. eight weeks uh compared to placebo
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and the primary endpoint to was the resolution on a show without worsening
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of white roses you see the red bar here is that the regular type armour
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you see the thirty nine percent of patients it reached its
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primary aim pointed compared to nine percent to the placebo group
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now i have to it's carol that they
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were very lucky because usually the percentage of
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of resolution of national placebo arm is between fifteen to
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twenty percent in more studies so they go to very low
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a response rating in this place to go on and then
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there is another copy out which is small sample size look
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that besides the low placebo response right nevertheless lower appetite works
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it works because it it make you wait a lose weight
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and the pharmacological weight loss therapy is improving and definitely
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say margaret tight works much much better than low rider tight
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this is the effects of arrival tied after forty eight
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weeks on average people lose out approximately eight kilo gram
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if you look at some margaret arteries adults dependent weight loss of four zero
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point four milligrams of margaret died that you lose twice as much almost putting kilograms
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in the same way to los that fact is also grow to be is decoded to a g. i. p. a. g. l.
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the one receptor argonne is that that that that exact sorry that but side
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uh in which is compared to black blue tie into which is the yellow line and
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increasing those a to up to its appetite
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at getting increasing the amount so a weight loss
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and actually both rather i retired and smarter tried
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that been approved do uh for therapy of obesity
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now uh it if you if you try to increase the uh the half life loading dalton o. g. l.
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p. one production by heating to be before in e. b. two or so the results on of this thing
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in fact disintegrating which is why do you use paid a bit taller jeez that
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had no effect uh on any parameter in this started there was
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no change a lever fact unknown changing liver enzyme no changing body weight
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last but not least is is that i know that interesting uh a class
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of saddam glucose quarter spotted two needles that
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a preventive absorption or look closer in the kidney
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so decreases dog who close uh by increasing the urinary excretion
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in addition the x. out a a lowering effect a slight lowering effect somebody white and uh
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um somebody featureless back some micro vascular events now
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integrate posing as been tested in a population of
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patients uh with fatigue ah and type two diabetes that
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this is a trial that are all just speak to patient and where today for twenty weeks it
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and uh the file out into the bar was major by m. route uh on p. d. f. a.
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and you see the compared to placebo where there is no change in in the buggy fussing group
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if i tend to leave or decreases from sixteen percent to two eleven percent
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there is not so are quite good in people with type two diabetes that probably they're
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not as good as in people with enough for the but we don't type two diabetes
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so just to summarise double tall latte step some good draw arcs to fly it's
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not for the leaders on which is the one feature recommended working incorporate this guideline
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although glitters on is not well accepted by
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patient because it makes makes increases your body weight
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not for me metaphor mean does not improve is the logical liver damage
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but definitely decreases the risk of about a cellular carcinoma in the beauty patients
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g. l. p. one agonies that are advertised the and hopefully we'll see
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there's tons of margaret tied it it before in it also not effective at
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and the grey fuzzy in might be effected but we're to wait a little bit more
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now the p. r. c. p. r. so course are very interesting class
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oh we're set or and it rocks uh that the act as i'm gonna stop beep yeah our second i have
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play tropic effect to for example a p. p. r. guy man p. p. l. outflow argon east
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uh um can i have a an increase in
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incidence since audience in sensitivity in the deepest issue
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a decrease in information due to the actual the cup for cell uh and
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the decrease the infrared project is is due to the action is there let's sell
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and also they can decrease the altos these and degrees ox that is tries
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to by increasing fate is deducted nation in improving like a pro the metabolism
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and there are several p. p. our uh a single
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or in combination p. p. r. gurney set design development uh
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uh been the most well tested out of fibre nor sort of it as a and they i about three thirty seven
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now is is the golden try out that has already been publishing custer introduced to be a goal
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it was testing at a fibre nor a into different those age
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eighteen becoming more than data each meeting them in the primary endpoint
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was a cheap to buy the highest dolls here the results are compared
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to the placebo twelve percent the bears nineteen percentage either primary endpoint it
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is not really striking but if you look
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at those people were selected based uh on uh
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i'm more importantly or day mainstay that need to be uh
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have a a better improvement uh uh by enough people know
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now this draw guy as a a very good metabolic profile that i can also improve
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up like a datum everybody and also the lever lip read a little group or five
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so we know that uh there is the phase three clinical trial
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that is running out there rolling uh almost a thousand patients that
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any terrain analysis of the first one thousand patient after seventy two weeks of treatment is the schedule
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they are expected to report on she wound on
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the first for my um so o. v. c. r.
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and we're looking forward to it the trial
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would also evaluate improvement occurred metabolic profile iowa
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and in that time i had a blast the or the
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data safety monitoring board issue the new positive recommendation for the continuation
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well the result phase three trial because of the fact that you provide
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is this an ida do well yeah i forgot mahogany star because that's the rate does out
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is car into using in the ah for therapy of type two diabetes
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they tested in three different dosage one milligram
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two milligram m. four milligram compared to placebo
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even um approximately a one hundred patients uh and then majored
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uh the change earlier for content uh in the nail t.
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now uh on a the highest those they do which is for
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me the graham was able to achieve some significant results compared to placebo
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it is it able to improve amino transfer is this is the percentage improvement i
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mean class place it was able to decreases
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the percentage decrease own lever factor in green
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like if yeah i one is life eternal our uh is
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also a current to test the the phase two ways study
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uh but we have no results so far we have results on anymore seawater
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riots or were randomised to receive a lot of free run or or a placebo
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and a lot of people enough it on or was shown to reduce the port operation
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to reduce the batik vascular resistance to and to improve eyebrows is that
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so in this preclinical model we gave very promising effect
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no not good to for enough for the n. x. therapy is the novel i put jane is is the normal i put jane is is that
00:14:13
you think this is off out to coming from normally car so particularly fruit toes
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now the number like project diseases increase in patient enough for the uh
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it takes uh uh eh it runs up up to twenty five percent uh
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all the totally paid a a production compared to five to ten percent of normal people
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fructose is high effect or that to a boast the novel i put jane is is
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that i still call a is um actually enzyme in this process to install a green
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as they call a it'll be shown out was tested
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uh as a um a strategy to decrease lever faster
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this says these are the printer is outside the
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compound uh uh that was tested uh in a um
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uh not for the patients that end uh de major
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um uh the amount a lot of thought into the bar
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after our uh twenty weeks uh of treatment to the
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highest dosage was able to achieve the highest degrees that
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of fat in the labour compared to the low dosage and compared to placebo
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the problem is that these compound was then tested in the artist daddy
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l. on or a combination on a uh without the uh with other drives up
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this is the need be told uh it's called the piece of course
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thought that he was tested by itself uh income initial with the lawn thirty
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being come in a show no we the announcer liked ignore steroid i
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fixed are going is to the facts or compare with placebo uproar is that
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three hundred ninety two patient restaurateur five in
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five groups so not them reach the statistical significance
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yeah you can see the now this is the need be tall
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or their facts ah or the combination i cheap to i. e.
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which she's significantly different compared to the placebo group there is a tendency
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the combination our system running a bit or we the facts
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are are counties the because the cheap this primary endpoint uh
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in twenty percent operation compared to placebo sixty seven patient it
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is a too long number to to to give a statistical significance
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now isn't that ah compound uh an s. t. d. one model later i see one
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is important and sign up for this thing to someone saturated ideas it at
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here they tasted uh these uh a
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compound uh in almost two hundred fifty patients
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for twenty weeks at a in the they could find a ah ah
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dawson related that reduction um mainly about about that
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which is the responders to to reduction a lever fart
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unnaturally solution without to worsening of fibrosis that
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was uh the primary implying to this that the
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in sixteen percent of patients the in the high those age group uh compared
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to five percent in the placebo and a drop in liver enzyme in both
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those h. so this compound this current to taste the interface three study
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what about the typical all drag stating set in omega three
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now stating sit they are definitely safe enough for the page or the should be given
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in particular told us that in has been demonstrated in grey started to
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lower the incidence of cardiovascular events to a greater extent in those with novelty
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who are at higher risk forgot device clay then to they do improve
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liver function tests i may also decrease the risk of about a seller carcinoma
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the problem is that most of these patients are not even state is
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because our uh the position our for a the of the liver damage
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now omega or free fit yes it's a a good
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course to decrease to restart the can decrease lever factor
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they have no we still you correct because see but definitely they have to
00:18:27
be used it into my total decrease the risk about but the seller casino
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now let's move to the drugs targeting the planetary pathway m. fibrosis or
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we know that fibrosis in the the is uh
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the most important uh is the logic facto related to
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labour related mortality here you see increasing fibrosis uh from i've to work
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for yeah for increases exponentially the
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a probability of liver related mortality right
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now effects ah is a a player tropic effect of that
00:19:06
is central to a multitude of partway inflammation fibrosis utter square roses
00:19:12
by lasted a mouse socio course glucose metabolism and also acts only paid metropolis
00:19:19
lately there's been also show on that uh uh you name on all those uh an
00:19:24
ocean beach from although that in my re doctor may lead to reduction important pretty sure
00:19:30
and also reduction in bacteria intestinal bacteria germs location
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these are the well known results uh all the free trial phase to be friends
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and frame trial that's compare placebo to twenty five milligram or vertical a. k. c. that
00:19:47
ah so uh this and so when we have p.
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yeah because the trial was stopped in advance because all the
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good results oh oh to draw get a than the patient in the
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treatment arm which isn't the blue one now uh we got an improvement that
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in each of the is the logical parameter rubber informations
00:20:08
to your toes you separate the seller ballooning and fibrosis
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so these are the side effects of one known as well
00:20:18
to realise the particularly the increase in l. d. yeah oh
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a concentration which is a a very an increase
00:20:26
after twelve weeks so treatments and and uh um
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it stops after this continuation or the drive got but definitely patience uh
00:20:36
should be given stating insert because these increase a particularly uh can tell
00:20:42
him particularly pronouncing goes to one not understating what it's not as important
00:20:47
in those one who are ready understating now this is the phase three
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we generate a a a a twenty four hundred patients randomised to restate placebo bit to critique
00:20:59
as the ten milligram vertical they can say twenty
00:21:02
five milligram with two endpoints for process improvement uh
00:21:07
equal or higher o. one stage uh we don't know worsening
00:21:10
on a show or measure solution would know war somehow fibrosis
00:21:15
its mandate team um they planned on entering
00:21:19
analysis uh to see if whether to stop continue
00:21:24
this trial and uh the show the results of visiting mounting to remain now is is that
00:21:30
um last to your ideas and the the show data which
00:21:34
probably k. c. twenty five milligram at the primary i'm pointer
00:21:39
all the improvement to lever for burroughs these without worsening
00:21:42
of nations here then trained intention to treat analysis that
00:21:46
eleven point nine percent uh of improvement of fibrosis
00:21:50
by a one or more stages in the placebo
00:21:54
compared to seventeen point six uh innovative probably k. c. ten
00:21:57
milligram in twenty three point one in a twenty five milligram
00:22:02
in these final on the right is even more clearer because that you showed you
00:22:07
how many this patient to get a free bruises improve the here you see
00:22:12
thirty eight percent or in the twenty five milligram khomeini
00:22:17
had their free bruises worsened which is exactly the reverse
00:22:22
and if you look at the amount of the percentage of people
00:22:27
who got an improvement to buy or more stages set which is a variant issues go all
00:22:33
you say that just four point five percent to this patient or reach this target in the placebo
00:22:39
um seven point one in the beauty product a milligram in thirteen point three hundred twenty five milligram
00:22:47
now well jody additional primary endpoint of nature's solution was not matter
00:22:52
did you go to k. c. that can improve nasty
00:22:55
disease activity based uh on the key is the logical parameters
00:23:00
they say is uh an improvement uh equal or higher but we're
00:23:05
one point uh all the single component of the nice score wore
00:23:09
it as a purchaser a balloon in lower information is the utterances
00:23:14
yeah you see there is an net improvement in input to sell a ballooning particularly in the twenty five milligram
00:23:20
an improvement to in a lot more information uh not really
00:23:24
improvement that just a slight change john stewart closes so probably
00:23:28
the reason why the the improvement in ask or was
00:23:32
not reaches because all the logo effect on theatres it's
00:23:38
what about the side effects
00:23:40
of course the the most important side effects of was per writers that was
00:23:45
experienced a by fifty percent uh all those into the to call a cat
00:23:49
uh s. it twenty five milligram twenty eight percent to ten milligram but look at t. yeah
00:23:56
nineteen percent to the placebo day this side effect is not
00:24:00
being described before the problem is that when you ask a patient
00:24:03
it do you see your nose blue when you take the spiel
00:24:07
satellite they will say yes i see sam tech trying to blue
00:24:14
it's all ninety percent of the station to refers to write ups
00:24:19
the most frequent uh there's a a band so where are mild to moderate
00:24:24
in severity inconsistent within nor profile a over to call okay i see it
00:24:29
the brightest they said this was highest in the first three manson degrees thereafter
00:24:35
ninety three percent of the main so we're mild to moderate nine percent up a shame to the basic only
00:24:41
k. c. twenty five milligram discontinued the treatments because all
00:24:46
writers it better be larry side effects so well not
00:24:51
a real important to less than one percent to no treatment group but
00:24:56
they censor cardiovascular events was plans across placebo vertical
00:25:00
a. k. c. ten milligram in twenty five milligram
00:25:03
there was just one death uh for my account in function and was in the placebo group
00:25:09
no i've mariah geographic soccer needs to design clinical developmental so far
00:25:15
the problem is that if you test even the best select trip effects so which
00:25:20
is a highly potent effect effects ah argon his stuff steal the side effects remains
00:25:27
this compound on who was tested uh uh mm in um
00:25:33
phase two randomised double blind placebo controlled three parts study
00:25:39
a u. c. e. uh fifty patiently placebo fifty in the the low dosage
00:25:45
of one hundred forty micro rama and fifty into high those h. two hundred micrograms
00:25:51
it was as effective as a bit to call the k. c. the in we do you see nail the
00:25:56
g. g. t. was also effectively reduces to your toes
00:26:00
is the problem is that right also was there as well
00:26:05
and six percent of this patient after twenty weaker weeks this continues because of right to set
00:26:11
and yeah the l. a. increase or was uh the who was recorded this web
00:26:18
now since our uh its entire start the he's the one that test
00:26:22
the that a face to be studied that tasted efficacy of sin created
00:26:27
or who chooses to see a sissy are two five or self tour
00:26:31
and target any stuff in a almost three hundred patients for one yeah
00:26:36
uh the n. line twelve nasty improve mentor
00:26:40
was not matter but they where able to
00:26:43
i mean the second i mean they are other m. point to which you will which we
00:26:48
use the improvement in fibrosis by at least one stage you without worse onions yet appetite this
00:26:54
ten percent to all people in the placebo uh to
00:26:57
achieve this endpoint compared to twenty percent uh in the
00:27:02
a treatment um and again this is this current to taste the the interface we started
00:27:09
and this is a negative try yeah i just to say the word and
00:27:12
the omen rica's sandwiches an hour open case busy needed so that is being
00:27:17
uh reportedly repeatedly uh tasted in several condition
00:27:23
and uh actually are in the study this was
00:27:26
show in the in the american doesn't raj association
00:27:29
meeting last to yeah you see that at the
00:27:32
percentage of those who who will improve the feeling blue
00:27:36
how you are in the placebo group compared to the request some and also who went to also
00:27:43
is higher in the treatment compared to placebo so
00:27:45
definitely eric us and should not be tested anymore
00:27:50
that we have a lot of compounds of course to to steal
00:27:56
i'm in phase free tire trial to be three and so on that we
00:28:01
have some drives that we can use
00:28:04
a impatient week i've today abilities but still
00:28:08
we are not very good to select patients who needs to be treated to because if
00:28:13
you look at it actually sent a hundred percent of patients that we see f. under forty
00:28:18
up to fifty percent i've nash twenty five percent abbott lance fibrosis
00:28:23
in it the general population twenty five percent that now for the
00:28:26
ten percent have nation in ten to fifteen percent have advance fibrosis
00:28:31
so the probably somehow to screen you once you screen how own to trade how can
00:28:36
we decide when to stop the treatment of whether to continue well to make false treatment
00:28:43
and uh i think that we should shave to to to all the different
00:28:48
concept uh uh shifting from clinical base category to procedure missing that please that
00:28:53
not thinking just uh in time so all liver patient
00:28:57
able to patient cardiovascular patient about integrate all this data
00:29:01
finish typing physiology it notices to p. b. t. metabolic
00:29:05
and so on just to get into data driven categories
00:29:09
and a high oh word error to the professor per se will help us
00:29:14
to understand the how to categorise and how to screen the station thank you
00:29:28
thank you very much for this very complete review nonchalant alone
00:29:34
skip which quite complex reach do not explicitly to use yours
00:29:39
nearly two really good too too few patients in some centres but other functions
00:29:48
well let's tattoos use easy to new pollutant once you know you
00:29:51
have these days to try i'll focus on emerald p. d. f. f.
00:29:54
and the duty of the detroit is not working because it is not such an effect on the stair to cease
00:30:01
and then the direct lease disappear but what made you need to see directly should
00:30:05
look at the other end points so it depends on the driveway and the the um
00:30:10
the fact that it is supposed to have the drive yeah because the e. for
00:30:14
example semi retired is supposed to decrease body weight is so he has to decrease the
00:30:20
a deeper faster and you cannot see any decrease in direct route then diaries
00:30:25
there is a problem but if it is um some drag that is targeting
00:30:31
my roses purely a for a gross it's like sonny gridlock for example and you don't
00:30:36
see any decrease in seattle's is that that's not supposed to be the target so it depends
00:30:46
and then um if i think it is a bit the for the statistical review my question is a bit
00:30:53
on the conceptual so we're starting so many drugs for
00:30:56
these important disease but potentially we're not you see stinky north
00:31:02
uh on the first type of world history that should be lifestyle change so
00:31:06
we have seen the defective small but the reason patient responding how could we improve
00:31:13
the audience will look pretty should or uh oh could we improve these partly so important part
00:31:19
of the treatment wouldn't prevention of disease now just the bustle that's many other colleagues a ah
00:31:26
hard doing that in the last i mean fifty
00:31:29
years or more than so uh there that knowledge
00:31:33
is a cardiology is that people odious with obesity
00:31:37
everyone is the l. two with with this problem
00:31:40
the problem is that uh there are not enough medical resources to targets
00:31:45
all the people who are these and and needs to to lose weight
00:31:49
the problem is that should be a structure intervention that
00:31:54
stocks for on this society starts from the government uh
00:31:58
for example a u. k. government uh at the same time
00:32:03
time put a tax on soul does i'm sure sure talks in the so that's so
00:32:09
they where are the increase in the tax on those uh so the
00:32:13
during so contained a an amount of photos higher than a certain threshold that
00:32:19
and suddenly all the companies that decreases the threshold of fructose ingersoll that's all
00:32:25
i mean it is this the kind uh i it should be an integrated intervention we we cannot uh
00:32:31
for to buy and i mean healthcare system
00:32:34
cannot afford this burden of obesity unrelated complication
00:32:40
thank you that's it that's it i think you are okay
00:32:47
this big difference i think that's okay
00:32:52
um most of your talks locust and where i live your targets not so much an intestinal targets
00:32:58
what do you think cheeks if you shoot the combined treatment
00:33:01
intestinal liver which is equal to slow customer you an example of
00:33:09
what what do you mean if g. s. nineteen for example
00:33:12
well in certain way g. l. p. one a. g. i. p. target both interested in lever
00:33:19
i mean and so we still do not know
00:33:22
enough about they got to be very interaction to target
00:33:27
to to make a ah a drag target job very
00:33:31
interesting data um gotta microbiology for example those are very exciting
00:33:37
but we are not yet in is that where we can consistently modify
00:33:44
the gas micro array out or to achieve improvement it into the pot
00:33:48
so i think it is a little bit preliminary but we should
00:33:53
look at the patience not at the organs indeed so
00:33:59
i mean we we should target to all the organs there's off acted by the same metabolic rearrangement
00:34:07
two four oh if you take a fixer it's important to target effects are in thirty
00:34:12
for and effects are intricate uh_huh you should not try to target only effects are ineffective sorry
00:34:22
well i think that we need more study to to to
00:34:27
get into it because it it is important for sure uh
00:34:33
but we do not know enough so far
00:34:38
but you have some trucks going move one hundred or so yeah it would be interesting to keep it it's
00:34:45
ah they order question is
00:34:50
no
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