Madrigal said they'd have topline results for the
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Posted On: 01/30/2022 6:39:35 PM
Re: onestepahead #116854
Madrigal said they'd have topline results for the first 900 patients in their phase 3 trial by January so they still have one day left.
What they have released is from an open label study but a direct comparison cannot be made. Cytodyn's study was 14 weeks, Madrigal's was 52 weeks. Another problem is that Cytodyn hasn't released data in a straight line manner, neither has Madrigal.
Resmetirom's mechanism of action is thyroid activated fat reduction. So far all drugs aiming at fat reduction in NASH have failed because stabilization or reduction of fibrosis is needed. Fibrosis is inflammation induced which is of course leronlimab's field.
Resmetirom's MRI-PDFF (fat measure) was -53% but that doesn't seem to line up with weight loss of over 5% in only 21% of patients and a weight gain of over 5% in 9% of patients. I'm betting the -53% is mean relative reduction.
A more comparable result from the 36 week open label extension was 11.1% they do list a mean relative reduction but that doesn't seem to be the comparative to use for Cytodyn's results.
Resmetirom's fibrosis 50% of the patients as measured by MRE - 15% reduction, as measured by Fibroscan 20%. The problem is what was the % across all patients?
Leronlimab - Average cT1 Reduction of 31.2 msec Over 14 Weeks for all 20 Patients
More than 80% of patients (5 out of 6) with severe NASH (cT1>1000 msec) had an average cT1 drop of 108 msec (-48 to -238 msec) and an average of about 20% fatty deposit reduction
11 of 20 patients (55%) had a decrease in cT1 and PDFF of about 75 msec and 16%, respectively
Without knowing the baseline for fibrosis there's no way to know what percentage of fibrosis reduction there was. With cT1 an 88 msec reduction corresponds to a 2 point drop in NAS score which is highly significant.
As with Madrigal's Fibroscan results there is no way to tell what leronlimab's overall PDFF results were since only results from a part of the population are presented.
https://www.madrigalpharma.com/wp-content/upl...AFLD-1.pdf
What they have released is from an open label study but a direct comparison cannot be made. Cytodyn's study was 14 weeks, Madrigal's was 52 weeks. Another problem is that Cytodyn hasn't released data in a straight line manner, neither has Madrigal.
Resmetirom's mechanism of action is thyroid activated fat reduction. So far all drugs aiming at fat reduction in NASH have failed because stabilization or reduction of fibrosis is needed. Fibrosis is inflammation induced which is of course leronlimab's field.
Resmetirom's MRI-PDFF (fat measure) was -53% but that doesn't seem to line up with weight loss of over 5% in only 21% of patients and a weight gain of over 5% in 9% of patients. I'm betting the -53% is mean relative reduction.
A more comparable result from the 36 week open label extension was 11.1% they do list a mean relative reduction but that doesn't seem to be the comparative to use for Cytodyn's results.
Resmetirom's fibrosis 50% of the patients as measured by MRE - 15% reduction, as measured by Fibroscan 20%. The problem is what was the % across all patients?
Leronlimab - Average cT1 Reduction of 31.2 msec Over 14 Weeks for all 20 Patients
More than 80% of patients (5 out of 6) with severe NASH (cT1>1000 msec) had an average cT1 drop of 108 msec (-48 to -238 msec) and an average of about 20% fatty deposit reduction
11 of 20 patients (55%) had a decrease in cT1 and PDFF of about 75 msec and 16%, respectively
Without knowing the baseline for fibrosis there's no way to know what percentage of fibrosis reduction there was. With cT1 an 88 msec reduction corresponds to a 2 point drop in NAS score which is highly significant.
As with Madrigal's Fibroscan results there is no way to tell what leronlimab's overall PDFF results were since only results from a part of the population are presented.
https://www.madrigalpharma.com/wp-content/upl...AFLD-1.pdf
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