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Msg  48850 of 50472  at  12/2/2023 12:29:19 PM  by


 In response to msg 48846 by  ml_c2
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Re: MDGL at Evercore yesterday

Itís not that simple. First, you canít assume only 25% of patients will try it. There just isnít any other treatment other than lifestyle changes and that hasnít really worked. Second, it is possible the potential patient population is underestimated since docs might not subject someone to a biopsy when there is no treatment available. Now, they will be able to prescribe without the need for a biopsy. Here is some data to mull over

Patients on resmetirom showed improvement in NAS components and fibrosis, and less worsening of NAS and fibrosis compared with placebo. Percentage improvement was seen in 31%, 33%, and 15% of patients on 80 mg resmetirom, 100 mg resmetirom, and placebo respectively; no change was seen in 51%, 48%, and 51% respectively; and worsening was seen in 18%, 19%, and 34% respectively.
The key secondary endpoint of LDL cholesterol lowering was also met. "There was a significant effect of resmetirom 80 and 100 mg on multiple atherogenic lipids/lipoproteins at both week 24 and 52," reported Harrison. The 52-week percentage change from baseline in LDL cholesterol was -14%, -20%, and 0% for the 80 mg resmetirom group, the 100 mg group, and the placebo group respectively.
"We also saw a significant reduction in liver enzymes [alanine transaminase (ALT), aspartate transaminase (AST) and gamma-glutamyl transferase (GGT)] relative to placebo both in terms of percentage and absolute measures," Harrison added. "[And] the change in liver enzymes was associated with the neutral biomarker that increases with resmetirom target engagement."
Resmetirom at both doses also resulted in a significant effect on MRI-PDFF and Fibroscan CAP. At week 52, 80 mg resmetirom, 100 mg, and placebo led to -42.1%, -51.4% and -10.4% change from baseline in MRI-PDFF, while Fibroscan CAP changed by -39.6%, -41.3%, and -14.5% respectively, reported Harrison. Liver volume dropped by -21.6% in the 80 mg group, -25.8% in the 100 mg group, compared with -1.0% in the placebo group. Spleen volume changed by -5.9%, -6.1%, and +3.2% respectively.
Liver stiffness, as measured by Fibroscan VCTE at week 52, changed from -3.7 KPa (F1B) to -2.0 KPa (F3) at 80 mg, and from -3.7 KPa (F1B) to -2.5 KPa (F2) and -3.3 KPa (F3) at the 100 mg dose.
Further analysis showed that improvements in fibrosis and NASH resolution were seen across all key subgroups, including baseline fibrosis stage (F2 or F3), NAS (<6, ≥6), type 2 diabetes status, age (<65 years, ≥65 years), and sex.

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Msg # Subject Author Recs Date Posted
48851 Re: MDGL minxmrphd 3 12/2/2023 12:50:20 PM

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