Sagimet partner Ascletis reports positive Phase 3 acne results for denifanstat; Sagimet starts Phase 1 of TVB-3567

Sagimet Biosciences Inc.

Denifanstat (50mg once daily) met all primary and secondary endpoints vs placebo in Phase 3 acne trial (n=480) in China.
Treatment success (IGA) 33.2% denifanstat vs 14.6% placebo (p<0.0001); total lesion count change −57.4% vs −35.4%.
Denifanstat well-tolerated; TEAEs comparable to placebo, only dry skin (6.3%) and dry eye (5.9%) above 5%.
Ascletis plans to submit denifanstat for approval to China's NMPA; Sagimet initiated Phase 1 of TVB-3567 for US acne.
Oral FASN inhibition offers novel mechanism for moderate-to-severe acne, a condition affecting 640M+ globally.

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