Kiniksa Outlines Next Steps for the Development of Mavrilimumab

About this update from Kiniksa Pharmaceuticals International, Plc

[{"type":"text","content":"- Defined regulatory pathway for Phase 3 clinical development of mavrilimumab in multiple indications - - Continued development in COVID-19-related ARDS represents fastest path to potential registration for mavrilimumab; Phase 3 data expected in Q1 2022 - HAMILTON, Bermuda, June 08, 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 outlined next steps for the development of mavrilimumab, an investigational fully-human monoclonal antibody that blocks activity of granulocyte macrophage colony stimulating factor (GM-CSF) by binding specifically to the alpha subunit of the GM-CSF receptor. “Recent favorable interactions with the FDA, based upon the clinical data generated with mavrilimumab in COVID-19-related ARDS, giant cell arteritis, and rheumatoid arthritis, underscore the broad utility of mavrilimumab and define a regulatory pathway for Phase 3 clinical development for each indication,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We believe the ongoing Phase 3 study of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration for the asset, and there remains a significant unmet need in these patients. Enrollment in our Phase 3 clinical trial is ongoing, and we expect data in the first quarter of 2022.” Mavrilimumab Development and Capital Allocation Interactions between Kiniksa and the U.S. Food and Drug Administration (FDA) on mavrilimumab in COVID-19–related acute respiratory distress syndrome (ARDS), giant cell arteritis (GCA), and rheumatoid arthritis (RA) resulted in a defined path for Phase 3 clinical development for each indication.Kiniksa believes development of mavrilimumab in COVID-19-related ARDS represents the fastest path to potential registration. Based upon data from the Phase 2 portion of the Phase 2/3 clinical trial of mavrilimumab in non-mechanically ventilated patients with COVID-19-related ARDS and discussions with the FDA, Kiniksa has adjusted the final sample size to appropriately power the Phase 3 portion of the clinical trial. The Phase 3 clinical trial will enroll a total of approximately 600 non-mechanically ventilated patients. The primary efficacy endpoint remain...

More updates from Kiniksa Pharmaceuticals International, Plc