Kiniksa Announces 28-Day Clinical Outcomes Data from Mavrilimumab Treatment Protocol in Severe COVID-19 Pneumonia and Active U.S. IND for Phase 2/3 Clinical Trial

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[{"type":"text","content":"HAMILTON, Bermuda, June 08, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced the presentation of 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation at the European E-Congress of Rheumatology (EULAR) 2020. The company also announced an active investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for its global placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation. Additionally, an investigator-initiated placebo-controlled study in the U.S. is enrolling patients.\n On Saturday, June 6, 2020, at EULAR 2020, Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy, delivered 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab in non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation. The presentation, entitled Mavrilimumab Improves Outcomes in Severe COVID-19 Pneumonia and Systemic Hyper-Inflammation, is available through the Science section of Kiniksa’s website (www.kiniksa.com). In the treatment protocol, 13 non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation were treated with a single intravenous dose of mavrilimumab 6 mg/kg upon admission to the hospital. Twenty-six contemporaneous non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation and with similar baseline characteristics upon admission to the hospital, including comorbidities, baseline inflammatory markers and respiratory dysfunction, were evaluated as a control-group. All patients received similar standard of care therapy, including antivirals and antibiotics. Over the course of the 28-day follow-up period, mavrilimumab-treated patients experienc...

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