Shares of biopharmaceutical firm Aclaris Therapeutics Inc (NASDAQ: ACRS) have made substantial gains on Tuesday after the company reported positive data from its mid-stage rheumatoid arthritis ATI-450 trial.
Aclaris’ stock price is trading over 156% higher at $15.10 per share.
ATI-450, an investigational oral MK2 inhibitor, used to treat patients with moderate to severe rheumatoid arthritis. It was developed by Aclaris, using its proprietary KINect™ drug discovery platform.
The trial involved 19 subjects with each patient receiving either ATI-450 at 50 mg twice daily or placebo, combined with methotrexate, for 12 weeks. The trial's primary endpoint was safety and tolerability with the secondary endpoints, including disease activity scores, and the change from baseline in high sensitivity C-reactive protein and appropriate endogenous cytokine levels.
The company said the drug demonstrated durable clinical activity over 12 weeks, was generally well-tolerated, and that data supports a new oral approach for the potential treatment of immuno-inflammatory diseases, such as rheumatoid arthritis.
The data also supports progression to a Phase 2b trial.
“We’re very pleased with these data which demonstrate that ATI-450 was generally well tolerated and showed durable clinical activity in RA over 12 weeks,” commented Dr David Gordon, Chief Medical Officer at Aclaris.
“We believe these data support our hypothesis that MK2 inhibition is an important novel target for the treatment of immuno-inflammatory diseases, such as rheumatoid arthritis, and we look forward to progressing ATI-450 to Phase 2b,” Dr Gordon added.