Aclaris Misses Primary and Secondary Endpoints in Rheumatoid Arthritis Study
Biopharmaceuticals company, Aclaris Therapeutics, Inc. (Nasdaq: ACRS) has failed to meet primary and secondary endpoints in a Phase 2b study of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, in subjects with moderate to severe rheumatoid arthritis (RA). Aclaris will discontinue further development of the ATI-450 program, including halting enrollment of its ongoing Phase 2a trial of zunsemetinib in psoriatic arthritis.
Doug Manion, M.D., Aclaris’ Chief Executive Officer, said, “We are deeply disappointed with the results of this trial and for patients suffering from rheumatoid arthritis. We would like to thank the patients and investigators for their participation in the trial, and I am proud of our team for their commitment to its execution. Despite this setback, we continue to look forward to the upcoming results of our Phase 2b trial of ATI-1777 in atopic dermatitis and initiating our Phase 2 clinical development program for ATI-2138.”
Highlights
ATI-450-RA-202 is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, dose-ranging study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of two doses of zunsemetinib plus methotrexate (MTX) versus placebo plus MTX in patients with moderate to severe RA.
The study enrolled 251 patients at approximately 40 trial sites in the United States, Poland, Bulgaria and Czech Republic.
In the trial, patients administered either the 20mg or 50mg dose did not meet the primary endpoint of ACR20 response or any of the secondary efficacy endpoints at 12 weeks, including ACR50 response, ACR70 response, and DAS28-CRP. There was no notable differentiation between zunsemetinib and placebo across any measures of efficacy at week 12.
Aclaris has a number of products remaining in its pipeline including ATI-1777 for moderate to severe atopic dermatitis, ATI-2138, for T cell-mediated diseases including ulcerative colitis, and ATI-2231, a potential treatment for pancreatic cancer and metastatic breast cancer.
As of September 30, 2023, Aclaris had aggregate cash, cash equivalents and marketable securities of $187.0 million.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.
