Kiniksa Commences Dosing of Vixarelimab Phase 2b Clinical Trial in Prurigo Nodularis

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[{"type":"text","content":"– Evaluating vixarelimab across a range of once-monthly dose regimens injected subcutaneously –\nHAMILTON, Bermuda, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced the commencement of dosing in the Phase 2b clinical trial of vixarelimab in prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules. Vixarelimab is a fully-human monoclonal antibody that targets oncostatin M receptor beta (OSMRβ). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020. “We are pleased to announce the commencement of dosing in the Phase 2b trial of vixarelimab in patients with prurigo nodularis. The study builds upon learnings from our prior preclinical and clinical work in the disease and will evaluate vixarelimab across a range of once-monthly dose regimens,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “By targeting the OSMRβ receptor, we believe vixarelimab has the potential to make a meaningful impact on the lives of patients suffering with prurigo nodularis by addressing both the pruritus and the skin nodules associated with this devastating disease.” The Phase 2b trial is a randomized, double-blind, placebo-controlled study designed to investigate the efficacy, safety, and pharmacokinetics of vixarelimab in patients with prurigo nodularis. The trial is expected to enroll approximately 180 patients experiencing moderate-to-severe pruritus. Patients will be randomized 1:1:1:1 to receive vixarelimab 540 mg, 360 mg, 120 mg, or placebo as a once-monthly subcutaneous injection. The primary efficacy endpoint is the percent change from baseline in the weekly-average Worst-Itch Numeric Rating Scale (WI-NRS) at Week 16. Key secondary endpoints include the proportion of patients achieving greater-than-or-equal-to 4-point weekly-average WI-NRS reduction at Week 16 and the proportion of patients achieving a 0/1 score (clear/almost clear) on the prurigo nodularis-investigator’s global assessment (PN-IGA) at Week 16. Kiniksa’s Breakthrough Therapy application was based on dat...

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