Acelyrin's Izokibep Shows Positive Phase 2b/3 Results in Psoriatic Arthritis
核心洞察
Acelyrin's izokibep demonstrated positive results in a Phase 2b/3 trial for psoriatic arthritis (搜索) (PsA), showing efficacy and safety over 16 weeks.
The trial evaluated izokibep at different subcutaneous doses (160 mg QW, 160 mg Q2W, and 80 mg Q4W) against placebo in 351 adult patients with active PsA.
Izokibep, a small protein therapeutic, inhibits IL-17A and is being assessed in multiple late-stage trials for immune-mediated diseases, including hidradenitis suppurativa (搜索) and uveitis (搜索).
Acelyrin, Inc. has announced positive 16-week results from its global Phase 2b/3 clinical trial of izokibep in patients with psoriatic arthritis (搜索) (PsA). The data will be presented as a late-breaking oral presentation at the 2024 European Alliance of Associations for Rheumatology (EULAR) Congress in Vienna, Austria.
The Phase 2b/3 trial (NCT05623345) is a randomized, double-blind, placebo-controlled, multi-center study that evaluated the safety and efficacy of izokibep in 351 adult patients with active PsA across 71 sites in the United States and Europe. Patients were randomized to receive izokibep subcutaneously at 160 mg every week (QW), 160 mg every two weeks (Q2W), or 80 mg every four weeks (Q4W), or placebo.
About Izokibep
Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency. Its small molecular size allows for robust tissue penetration, and an albumin-binding domain extends its half-life. Acelyrin believes these characteristics may provide clinically meaningful benefits for patients, including resolution of key disease manifestations. Izokibep is currently in late-stage trials for moderate-to-severe hidradenitis suppurativa (搜索) (HS), psoriatic arthritis (搜索) (PsA), and uveitis (搜索), with plans to initiate a Phase 3 program in axial spondyloarthritis (搜索) (AxSpA).
Psoriatic Arthritis and Unmet Needs
Psoriatic arthritis (搜索) (PsA) is a chronic immune-mediated inflammatory disease affecting approximately 30% of the 125 million people living with psoriasis worldwide. PsA is characterized by destructive joint inflammation, psoriasis, and enthesitis, significantly reducing the quality of life for affected individuals. There remains a significant unmet need for more effective therapies to address all disease manifestations of PsA.
Presentation at EULAR 2024
The late-breaking oral presentation at EULAR 2024 will be delivered by Philip Mease, MD, MACR, Director of Rheumatology Research at Swedish Medical Center. The presentation, titled "Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Patients with Active Psoriatic Arthritis (搜索): Week 16 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2b/3 Study," is scheduled for Saturday, June 15, 2024, from 9:30 AM to 9:40 AM CEST.