Aclaris (ACRS) Lead Drug Fails Rheumatoid Arthritis Study
Shares of Aclaris Therapeutics ACRS lost 86.4% in one trading day on Nov 13 after management announced top-line results from a phase IIb study (ATI-450-RA-202). The study evaluated its lead pipeline candidate, zunsemetinib inrheumatoid arthritis (“RA”) indication.
The ATI-450-RA-202 study evaluated two doses of zunsemetinib (20mg and 50mg) combined with methotrexate (MTX) against the combination of placebo and MTX in patients with moderate to severe RA who have had an inadequate response to MTX alone. The study failed to achieve its primary or secondary efficacy endpoints following 12 weeks of treatment at both doses of the drug.
Study participants who received either of the two doses of zunsemetinib did not show any notable differences across any measures of efficacy compared with placebo. No significant safety findings were observed.
Based on overall results from the study, Aclaris decided to discontinue further development of zunsemetinib, including halting enrollment in the ongoing Phase IIa study on zunsemetinib in psoriatic arthritis indication.
Shares of Aclaris Therapeutics have plunged 95.9% year to date compared with the industry’s 16.4% decline.
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This is the second clinical setback faced by management this year with regard to zunsemetinib. Earlier in March, Aclaris reported preliminary top-line data from a phase IIa study on zunsemetinib in hidradenitis suppurativa (“HS”) indication, which failed to achieve its primary and secondary efficacy endpoints.
Following the decision to discontinue the development of zunsemetinib, Aclaris will focus on the development of its other pipeline candidates, namely ATI-1777 (for atopic dermatitis), ATI-2138 (for T-cell mediated autoimmune diseases) and ATI-2231 (for pancreatic cancer and breast cancer).
Before 2023-end, Aclaris expects to report top-line data from a phase IIa study on ATI-1777 in moderate to severe atopic dermatitis. Management plans to start a mid-stage study on ATI-2138 in ulcerative colitis early next year.
Aclaris Therapeutics, Inc. Price
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Zacks Rank & Other Stocks to Consider
Aclaris currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include Apellis Pharmaceuticals APLS, Avid Bioservices CDMO and Biohaven BHVN, also carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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