Kiniksa Announces Results from Phase 3 Trial of Mavrilimumab in COVID-19-Related ARDS

About this update from Kiniksa Pharmaceuticals International, Plc

[{"type":"text","content":"HAMILTON, Bermuda, Dec. 28, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that the Phase 3 portion of the Phase 2/3 trial of mavrilimumab in COVID-19-related acute respiratory syndrome (ARDS) did not meet the primary efficacy endpoint. Mavrilimumab is an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα). “The Phase 3 study of mavrilimumab in COVID-19-related ARDS did not provide the expected outcome, however we are proud of our efforts to help patients in need during this unprecedented time. We greatly appreciate the participation of the patients, their families, the investigators, and the Kiniksa employees who made this study possible,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “We continue to believe in the potential broad utility of mavrilimumab and are evaluating next steps for the molecule. Our current strategy focuses our resources on the ARCALYST franchise, including the commercial execution in recurrent pericarditis, as well as the development of vixarelimab and our anti-CD40 program, KPL-404.” The Phase 2/3 trial is a global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of mavrilimumab for the treatment of hospitalized, non-mechanically-ventilated adult patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation. A total of 582 patients in the Phase 3 portion of the trial were randomized in a 1:1:1 ratio to receive a single intravenous dose of mavrilimumab 10 mg/kg, 6 mg/kg, or placebo. The Phase 3 portion of the trial did not meet its primary efficacy endpoint of proportion of patients alive and free of mechanical ventilation at Day 29. About KiniksaKiniksa is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s portfolio of assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions, and offer the potential for differentiation. Thes...

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