Arthritis data breathes life back into Acelyrin

11 Mar 2024
firstwordpharma.com
Clinical ResultIPO
Acelyrin showed signs of a comeback after announcing its psoriatic arthritis (PsA) treatment met the primary endpoint of a Phase IIb/III trial that’s expected to be the first of two registrational studies. The news bumped up the company’s shares by 11% on Monday.
The study win was a welcome sight after the same compound, IL-17A inhibitorIL-17A inhibitor izokibep, failed a Phase IIb/III trial for moderate-to-severe hidradenitis suppurativa last September.
For the 16-week PsA trial, Acelyrin said that izokibep met the primary endpoint of American College of Rheumatology (ACR) 50 “with high statistical significance.”
While specific responder rates were not disclosed, Acelyrin said the candidate demonstrated “consistent high magnitude absolute responses,” adding that izokibep achieved clinically meaningful resolution in patients with the highest burden of enthesitis, a PsA symptom that involves inflammation at the sites where connective tissues attach to bones. According to Acelyrin, this beneficial effect has not been previously reported by other autoimmune drugs.
The study enrolled 351 adult patients with active PsA to receive a 160mg injection of izokibep either every week or every other week, an 80mg dose every four weeks, or placebo.
Chief executive Shao-Lee Lin said in a statement that the every-other-week dosing data gives Acelyrin conviction that that izokibep regimen “delivers higher clinical responses than those reported by the approved IL-17A agents, and responses comparable to those reported by the IL-17A&F agents without the associated safety liabilities.”
However, Acelyrin said the dose sequencing of the 80mg and the bi-weekly 160mg arms were impacted by a “third-party programming error.” The company first disclosed in November that the trial was affected by a clinical trial execution error involving its CRO and one of the vendors engaged by the CRO, which programmed the dose protocol incorrectly.
While the study win helped boost Acelyrin’s stock on Monday, its share price is less than half that of its public debut in mid-2023 – when it closed the third largest biotech IPOs in the past six years by selling 30 million shares at $18 a piece to raise $540 million. For more, see Vital Signs: CG Oncology breaks into the top ten.
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