ACELYRIN, INC. Announces Long-term 32-Week Data from the Phase 2b Trial of Izokibep in Hidradenitis Suppurativa Demonstrating Sustained Responses and Deepening Clinical Benefit - Improving Quality of Life for Patients - Seite 2

“It’s heartening to see the exciting results from this longer term follow up across all of the important manifestations of this debilitating disease, despite the initial primary endpoint of this study not meeting statistical significance,” said Shao-Lee Lin, MD, PhD, Founder and CEO of ACELYRIN. “Across indications, we have observed clinically meaningful and potentially differentiated benefit from izokibep. We have consistently seen responses in high order efficacy measures such as HiSCR100 in HS and ACR70 and PASI100 in PsA, that move patients toward disease resolution. This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”

Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class. Potential for differentiation was demonstrated with higher clinical responses achieved earlier than reported by other IL-17A agents and the IL-17A&F agents without evidence to date for increased risk of infection, especially fungal or suicidal ideation and behavior, in a patient population predisposed to infection and clinical depression.

“The pain and discomfort that people living with HS experience on a daily basis is extremely debilitating,” said Falk Bechara, MD, Clinical Professor in the Department of Dermatology at the Ruhr-University Bochum. “These data are impressive, showing izokibep dose ordered, fast speed of onset across endpoints. The consistency and magnitude of responses in resolution of abscesses and nodules, reduction in draining tunnels, and improvement in pain, impact overall quality of life and suggest that izokibep could be a significant therapeutic for HS, with a positive benefit risk in addressing an unmet need.”

Topline data from an ongoing phase 3 trial in HS is expected by the end of 2024. A confirmatory phase 3 trial of approximately 400 patients is planned to address guidance on size of safety database given the FDA no longer considers moderate-to-severe HS an orphan disease.

About the Phase 2b Hidradenitis Suppurativa clinical trial
The Phase 2b clinical trial (NCT05355805) is a global, multi center, randomized double-blind, placebo-controlled, trial evaluating the safety and efficacy of izokibep dosed 160 mg every week (QW) or every two weeks (Q2W) versus placebo. At week 16, patients who received placebo were randomized to either the weekly or every two week active treatment arm and all patients were assessed through week 32. The objective of the study was to determine the effect of izokibep versus placebo on various measures of clinical impact and determine the appropriate dose(s) for further clinical development in hidradenitis suppurativa.