Kiniksa Announces Early Evidence of Treatment Response with Mavrilimumab in 6 Patients with Severe COVID-19 Pneumonia and Hyperinflammation

 - All 6 patients treated with mavrilimumab showed resolution of fever and did not progress to mechanical ventilation; follow-on controlled study in Italy planned - 
- Consortium of U.S. academic sites planning to commence investigator-initiated studies in parallel -
- Evaluating a Phase 2/3 clinical development program pending regulatory feedback and data from treatment experiences -

HAMILTON, Bermuda, March 31, 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 early evidence of treatment response with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα), in a treatment protocol in patients with severe coronavirus 2019 (COVID-19) pneumonia and hyperinflammation. The treatment protocol was conducted by 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 within a COVID-19 Program directed by Professor Alberto Zangrillo, Head of Department of Anesthesia and Intensive Care of the Scientific Institute San Raffaele Hospital and Professor in Anesthesiology and Intensive Care, Università Vita-Salute San Raffaele.

The treatment protocol with the investigational drug mavrilimumab was a prospective, interventional, single-active-arm, single-center pilot experience. Patients suffering from severe pulmonary involvement of COVID-19, acute respiratory distress, fever, and clinical and biological markers of systemic hyperinflammation status​ were treated with a single intravenous dose of mavrilimumab. The objective was to reduce incidence of progression of acute respiratory failure, the need of mechanical ventilation, and the transfer to the intensive care unit.

To date, 6 patients have been treated with mavrilimumab in the treatment protocol. All patients showed an early resolution of fever and improvement in oxygenation within 1-3 days. None of these patients have progressed to require mechanical ventilation. Mavrilimumab has been well-tolerated.

“Patients with COVID-19 die of a devastating pneumonia caused by a hyperinflammation syndrome,” said Professor Lorenzo Dagna. “Last week my team administered mavrilimumab to 6 patients who were experiencing a steep decline of pulmonary status due to COVID-19 pneumonia. All patients responded on treatment, and 3 out of the 6 patients were discharged within 5 days. The data are compelling, and I look forward to continued studies of mavrilimumab in COVID-19.”