We have competition nowAclaris stock surges on positive data from mid-stage rheumatoid arthritis ATI-450 trial
- Aclaris Therapeutics (NASDAQ:ACRS) shares up ~62% premarket after it announces positive preliminary top-line results from a 12-week, Phase 2a clinical trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450, in subjects with moderate to severe rheumatoid arthritis (RA).
- In the trial, 19 subjects were randomized in a 3:1 ratio and received either ATI-450, an investigational oral MK2 inhibitor, at 50 mg twice daily or placebo, in combination with methotrexate, for 12 weeks.
- The primary endpoint of the study was safety and tolerability with key secondary and exploratory endpoints including the disease activity scores, DAS28-CRP and ACR20/50/70, and the change from baseline in high sensitivity C-reactive protein ((hsCRP)) and relevant endogenous cytokine levels.
- In the trial, ATI-450 showed durable clinical activity, as defined by a marked and sustained reduction in DAS28-CRP and evaluation of ACR20/50/70 responses over 12 weeks, the company said.
- Aclaris expects to submit a full analysis of the Phase 2a data for publication in a peer-reviewed scientific journal.
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