Aclaris Therapeutics Inc. (NASDAQ: ACRS) shares more than doubled to start out the week after the company announced positive results from its midstage rheumatoid arthritis (RA) study.
Specifically, the results come from the Phase 2a study of ATI-450, an investigational oral MK2 inhibitor, in subjects with moderate to severe RA. ATI-450 was developed internally utilizing Aclaris’s proprietary KINect drug discovery platform.
The primary endpoint was safety and tolerability. Key secondary and exploratory endpoints included 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.
Management did note that as this trial was designed to generate proof of concept, it was not powered to detect statistically significant outcomes on efficacy endpoints.
The mean DAS28-CRP score at baseline was 5.71 for the 16 subjects in the treatment arm and 5.77 for the three subjects in the placebo arm. Seventeen subjects (15 in the treatment arm and two in the placebo arm) completed 12 weeks of treatment.
Management said that overall it was very pleased with the data that demonstrated that ATI-450 was generally well tolerated and showed durable clinical activity in RA over 12 weeks. The firm believes these results support the hypothesis that MK2 inhibition is an important novel target for the treatment of immuno-inflammatory diseases, such as RA, and it looks forward to progressing ATI-450 to Phase 2b.
Excluding Tuesday’s move, Aclaris stock had outperformed the broad markets with a gain of about 198% over the past year. In the past six months alone, the stock was up closer to 166%.
Aclaris stock traded up about 153% on Tuesday to $14.85, in a 52-week range of $0.70 to $16.68. The consensus price target is $5.83.