Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA) has announced that the third phase part of the Phase 2/3 mavrilimumab study in COVID-19 related acute respiratory syndrome failed to meet the primary efficacy endpoint. Mavrilimumab is an experimental completely human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSFR) in granulocyte macrophages.
Phase 3 study failed to give expected outcomes
Chief Executive Officer and Chairman of Kiniksa Sanj K. Patel said, “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. We continue to believe in the potential broad utility of mavrilimumab and are evaluating the 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 study is a worldwide, placebo-controlled double-blind study evaluating the efficacy and safety of mavrilimumab for the treatment of hypoxia and severe COVID-19 pneumonia/hyper inflammation in hospitalized, non-mechanically ventilated adult patients. In the Phase 3 leg of the study, 582 patients were randomly assigned to receive a single intravenous dosage of mavrilimumab 10 mg/kg, 6 mg/kg, or placebo in a 1:1:1 ratio. Unfortunately, the major effectiveness endpoint of the Phase 3 section of the trial, the proportion of patients alive and free of mechanical ventilation at Day 29, was not met.
Mavrilimumab evaluated in rheumatoid arthritis in Europe
Mavrilimumab was previously tested in rheumatoid arthritis in Phase 2b clinical trials in Europe, where it met all of the primary effectiveness and safety goals. The company is assessing the next steps for mavrilimumab in giant cell arteritis. The primary and secondary efficacy outcomes of Phase 2 clinical study of mavrilimumab in GCA were both statistically significant. In 2020, the US Food and Drug Administration designated mavrilimumab as an Orphan Drug for the treatment of GCA.