- Aclaris Therapeutics Inc ACRS announced preliminary topline results from a 12-week, Phase 2a study of zunsemetinib (ATI-450) for moderate to severe hidradenitis suppurativa.
- The study did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count (AN) of zunsemetinib 50mg BID versus placebo at week 12.
- The study also did not meet the secondary efficacy endpoints assessed in the topline data, including the percentage of patients achieving HiSCR-50.
- The placebo effect observed across all efficacy endpoints was higher than observed in other published HS studies reported to date.
- Zunsemetinib was generally well tolerated. Safety findings were generally consistent with observations from prior clinical studies of zunsemetinib.
- PK and PD were generally consistent with observations from prior clinical studies of zunsemetinib.
- A preliminary analysis of endogenous plasma cytokines and chemokines in patients with a confirmed dose of study treatment on the day of blood draw demonstrated zunsemetinib-dependent inhibition relative to placebo.
- Price Action: ACRS shares are down 49.60% at $6.44 on the last check Monday.
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