This morning, Hamilton, Bermuda based biopharmaceutical company Kiniksa Pharmaceuticals Ltd. (KNSA:NASDAQ) 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 company advised that "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 firm stated that the treatment protocol tested the investigational drug mavrilimumab in an interventional, single-active-arm 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 with the objective of reducing incidence of progression of acute respiratory failure, the need of mechanical ventilation, and the transfer to the intensive care unit."
The company noted that so far six patients have been treated with mavrilimumab using the treatment protocol and that mavrilimumab has been well-tolerated. The firm reported that all of the patients showed an early resolution of fever and improvement in oxygenation within 1-3 days and none of the patients' conditions progressed to require mechanical ventilation.
Professor Dagna commented, "Patients with COVID-19 die of a devastating pneumonia caused by a hyperinflammation syndrome...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."
The company's Chief Medical Officer John F. Paolini, MD, PhD, remarked, "These data are the first reported evidence of early treatment response with GM-CSF antagonism in COVID-19...By blocking GM-CSF signaling, mavrilimumab works upstream of interleukin-6 and potentially addresses the underlying pathophysiology of the hyperinflammation which may be responsible for the severe pneumonia of COVID-19. Controlled clinical studies are required to fully characterize the potential of mavrilimumab in this disease. Building upon our activities over the last several weeks, we continue to evaluate the data and next steps, including a potential Phase 2/3 clinical development program."
The company explained that mavrilimumab has not yet been approved for any indication in any country and described mavrilimumab as "an investigational fully-human monoclonal antibody that is designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor (GM-CSFRα)." The company listed that the lead indication for mavrilimumab is giant cell arteritis which is an inflammatory disease of medium-to-large arteries. The firm advised that mavrilimumab was safely dosed and met primary endpoints in Phase 2b clinical studies in Europe of more than 550 patients suffering from rheumatoid arthritis.
Kiniksa Pharmaceuticals is focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating autoinflammatory and autoimmune diseases with significant unmet medical need. Kiniksa's pipeline of product candidates across various stages of development include Rilonacept for the potential treatment of recurrent pericarditis; Mavrilimumab for the potential treatment of giant cell arteritis; KPL-716 for the potential treatment of a variety of pruritic diseases, including prurigo nodularis, a chronic inflammatory skin condition; and a few others.
Kiniksa Pharmaceuticals has a market capitalization of around $678.8 million with about 55.55 million outstanding shares. KNSA shares opened nearly 37% higher today at $16.74 (+$4.52, +36.99%) over the yesterday's closing price of $12.22. The stock has traded today between $14.52 and $17.46 per share and currently is trading at $15.43 (+$3.21, +26.27%).[NLINSERT]
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