WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) this week announced disappointing top-line results from a Phase 2b study of zunsemetinib (ATI-450) in patients with moderate to severe rheumatoid arthritis (RA). The results showed that patients administered either the 20mg or 50mg dose of zunsemetinib did not meet the primary endpoint of ACR20 response or any secondary efficacy endpoints at 12 weeks.
The ATI-450-RA-202 study is a double-blind, placebo-controlled, and dose-ranging trial. It aimed to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of two doses of zunsemetinib plus methotrexate (MTX) versus placebo plus MTX in RA patients who had an inadequate response to MTX alone. The study enrolled 251 patients across three treatment arms at approximately 40 trial sites in the United States, Poland, Bulgaria, and the Czech Republic.
In light of these findings, Aclaris has decided to discontinue further development of the ATI-450 program, which includes halting enrollment of its ongoing Phase 2a trial of zunsemetinib in psoriatic arthritis.
Aclaris Therapeutics’ CEO, Doug Manion, M.D., expressed deep disappointment over the unsuccessful trial of zunsemetinib for rheumatoid arthritis patients. He extended his gratitude towards the patients and investigators involved in the trial and commended his team’s dedication.
Despite this setback, he reaffirmed Aclaris’ commitment to advancing its other pipeline programs. The company eagerly anticipates the results of its Phase 2b trial of ATI-1777 in atopic dermatitis and is preparing to initiate the Phase 2 clinical development program for ATI-2138.
The company remains optimistic about its other pipeline updates. In June 2021, Aclaris reported positive results from its Phase 2a trial of ATI-1777, a topical JAK1/3 inhibitor, in patients with moderate to severe atopic dermatitis. The company expects to provide results from its 250-patient, six-arm, Phase 2b study on ATI-1777 by year-end.
Another promising candidate, ATI-2138, an oral covalent ITK/JAK3 inhibitor, showed promising pharmacokinetic and pharmacodynamic properties that could positively impact T cell-mediated diseases in a recent multiple ascending dose study. Aclaris anticipates beginning the Phase 2 program with ulcerative colitis as the initial indication in early 2024.
However, Aclaris is discontinuing its current efforts on ATI-2231 as a potential treatment for immuno-inflammatory diseases. It is now focusing on the potential of ATI-2231 as a treatment for pancreatic cancer and metastatic breast cancer and in preventing bone loss in patients with metastatic breast cancer.
Despite the setback with zunsemetinib, Aclaris remains financially robust. As of September 30, 2023, the company had aggregate cash, cash equivalents, and marketable securities of $187.0 million.
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