Pennsylvania-based Aclaris Therapeutics will stop development of zunsemetinib after it failed to meet the primary endpoint in a Phase II study for rheumatoid arthritis.
Pictured: Illustration of stock price dropping/iStock, coffeekai
Aclaris Therapeutics, a Pennsylvania-based biotech focused on immune-inflammatory diseases, is experiencing a severe stock fall after a Phase II failure.
On Monday, Aclaris announced that a Phase II investigation of zunsemetinib (ATI-450), an MK2 inhibitor being tested in patients with moderate to severe rheumatoid arthritis, did not reach the primary endpoint of ACR20 response at either the 20mg or 50mg doses. The trial did not reach any of its secondary endpoints, and no “notable differentiation” between the drug and a placebo “across any measures of efficacy” at week 12 was reported.
Aclaris is stopping further development of the drug and putting the kibosh on recruitment for a Phase IIa study of zunsemetinib in patients with psoriatic arthritis. The company’s stock price fell over 86% on Monday following the data drop, putting it well into the penny stock range.
“We are deeply disappointed with the results of this trial and for patients who have rheumatoid arthritis,” Aclaris CEO Doug Manion said in a statement. He added that Aclaris will focus on other assets and readouts, including its Phase II trial of ATI-1777, a “soft” JAK inhibitor designed to treat atopic dermatitis, and a Phase II readout for its ATI-2138 program, an ITK/JAK3 inhibitor in development for T-cell mediated autoimmune diseases.
Zunsemetinib has seen failure before. In March, the drug missed the primary and secondary endpoints in a Phase II trial investigating the drug in moderate to severe hidradenitis suppurativa.
In its third quarter 2023 report, Aclaris marked a loss of $29.3 million for the quarter while bringing in only $9.3 million in revenue, compared to $19 million from the third quarter of last year. Aclaris said in the report that this was primarily due to an upfront payment under a “non-exclusive patent license” agreement with Eli Lilly in the third quarter of last year. So far, Aclaris has logged a loss of $87 million for 2023, while total revenue is reported at $13.7 million.
Aclaris is not the only biotech to face data struggles recently. Last week, Atara Biotherapeutics’ multiple sclerosis drug also did not reach its primary endpoints, leading to a 57% drop in its stock price.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
