Quote:Their old CEO who has been indicted for fraud, pumped LL for NASH, 2 yrs ago, but the data was poor.
Oh really! Does he think the better p values in resmetirom mean it's better?
Quote:leronlimab phase 2 NASH trial - Mean percent change from baseline PDFF was significantly reduced in the 350 mg group vs placebo (-5.94% vs +9.85%, p = 0.008) but not in the 700 mg group (+3.75% vs +9.85%, p = 0.135). Mean change cT1 was significantly reduced in the 350 mg group vs placebo (-24.38 ms vs +27.64 ms, p = 0.021) but not in the 700 mg group (-2.73 ms vs +27.64 ms, p =0.059). Significant reductions were seen in the 350 mg subgroup with baseline cT1 875 ms in both PDFF and cT1 vs placebo (-4.37% vs +9.85%, p =0.020 and -42.00 ms vs +27.64 ms, p = 0.011) respectively. In subjects with cT1 950 ms at baseline, PDFF and cT1 were significantly reduced with 350 mg vs placebo (-9.39% vs +9.85%, p = 0.027 and -68.85 ms vs +27.64, p = 0.009) respectively. Mean change in baseline to week 14 for M65 ELISA (cK18 and K18) decreased in the 350 mg group (340.55 to 332.4 U/L; -8.18) while increased in placebo (301.96 to 411.64 U/L; +109.78).
There was no grade 3 or higher drug related treatment emergent adverse event. Injection site reaction and mild diarrhea occurred more frequently with leronlimab than placebo but were not associated with discontinuation.
The better p values in Madrigal's phase 3 trial is a consequence of a 13 week trial for leronlimab vs. a 52 week trial for resmetirom. More importantly that difference is because of the number of patients involved, 22 in the 350 mg arm for leronlimab and 323 for resmetirom 100mg group.
If I am correct about the single allele CCR5 Delta 32 gene variation being the cause of worse results in 700mg the mouse study will show it. There will be no CCR5 Delta 32 in the mice so the 700mg will be significantly better. If those with single allele Delta 32 are excluded from any future human trial then 700mg will beat 350mg with no problem.
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