萨吉梅特生物科学公司(SGMT):与Ascletis合作的3期试验证实denifanstat在痤疮治疗中的疗效






SGMT’s partner Ascletis (covered by Ziyi Chen) announced positive topline results from its Ph3 trial of denifanstat in patients with moderate to severe acne. Part of a joint-development program between SGMT/Ascletis, the study evaluated denifanstat’s efficacy and safety in 480 patients treated with either denifanstat 50mg (QD, oral) or matching placebo for 12 weeks and found denifanstat to achieve statistically significant improvements over placebo on all primary endpoints (33.2% of patients achieving treatment success and 57.4%/63.5% reductions from baseline in total/inflammatory lesion counts; versus 14.6% and 35.4%/43.2% for placebo), as well as key secondary and secondary endpoints, in addition to a favorable safety profile (details within). These results, which were in line with our expectations based on prior Ph2 data, reinforce the benefit of FASN inhibition in acne and should support regulatory approval in China (Ascletis announced plans for NMPA submission imminently). Per the lice
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