700mg/350mg NASH Data Abstract Available Now PD

Quote:

---

Analyses were conducted on the full analysis set (n = 72) of whom 44% were of Hispanic or Latino ethnicity and 58% with baseline moderate to severe fibro-inflammation (cT1 875 ms). 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). In post hoc analyses, mean percent PDFF and mean cT1 were significantly reduced in the pooled 350 + 700 mg group compared to placebo (-1.09% vs +9.85%, p = 0.014 and -13.30 ms vs +27.64 ms, p = 0.013) and in the 700 mg group with genetic haplotypes known to over produce CCR5 compared to placebo (-27.9% vs +9.85%, p = 0.006 and -45.4 ms vs +27.64 ms, p = 0.013). 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

---