ACELYRIN has announced that the global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met its primary endpoint with high statistical significance.
Positive long-term data from a Phase 2b clinical trial in hidradenitis suppurativa (HS) were also announced.
In the Phase 2b/3 PsA trial the primary endpoint of ACR50 at week 16 was met with high statistical significance. Robust clinical responses were also achieved for ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity. Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class. The PsA trial had a low study discontinuation rate of less than 3%. Mild-to-moderate injection site reactions (ISRs) were observed with discontinuations due to ISR less than 2%.
“It is encouraging to see the positive effect of izokibep in these hard to treat patients. Deep responses have been reported with izokibep across indications. High orders of response such as ACR70 in PsA and HiSCR100 in HS demonstrate the unique ability of izokibep to help patients otherwise inadequately treated,” says Affibody Chief Medical Officer, Nikolai Brun.
In PsA, ACELYRIN expects the reported Phase 2b/3 trial to be the first of two registrational trials.
Long-term data from a Phase 2b HS trial
In addition, ACELYRIN has announced long-term data from a Phase 2b HS trial. The data demonstrated that continued treatment with izokibep led to further clinical improvements over time with maintained favorable safety profile. These results are from an open label extension and include all subjects through week 32.
Patients who switched from placebo to izokibep at week 16 achieved a similar speed and magnitude of response, as those who began treatment with izokibep at baseline, for HiSCR, draining tunnels, skin pain, and Dermatology Life Quality Index. High orders of HiSCR were achieved with the majority of patients achieving HiSCR75 and about a third achieving HiSCR100 by week 16 and through 32 weeks.
“We are pleased to see the exciting results – especially the robust placebo cross-over responses – from this long-term follow up in HS, despite the initial primary endpoint of this study not meeting statistical significance. The HS data together with the positive data in PsA bolsters our excitement for izokibep and confirms izokibep as a leading candidate among the next generation IL-17 treatments,” says David Bejker, CEO of Affibody. “Izokibep continues with strong momentum and we look forward to additional readouts during the year from ongoing late-stage trials.”
Topline data from an ongoing Phase 3 HS trial are expected by the end of 2024. ACELYRIN plans an additional Phase 3 trial in HS of approximately 400 patients to address FDA guidance on size of safety database.
Photo of David Bejker: Affibody
