Kiniksa Announces Lancet Rheumatology Publication of Clinical Outcomes with Mavrilimumab in COVID-19
HAMILTON, Bermuda, June 17, 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 that 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 were published in The
The 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab are described in a manuscript by De Luca et al1 entitled, “GM-CSF Blockade with Mavrilimumab in Severe COVID-19 Pneumonia and Systemic Hyperinflammation: A Single-Centre, Prospective Cohort Study,” which can be accessed online at the following link: http://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)3017 ....
“The data published in The Lancet Rheumatology are supportive of further development of mavrilimumab in COVID-19 pneumonia,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “The mavrilimumab-treated patients experienced earlier and improved clinical outcomes compared to controls, which is particularly impactful given the significant level of baseline disease, as evidenced by the magnitude of severe hypoxia and elevated inflammatory markers, such as C-reactive protein and interleukin-6. We look forward to evaluating mavrilimumab in our global placebo-controlled Phase 2/3 clinical trial in this population.”
The publication also includes an accompanying editorial highlighting the similarities between the aberrant immune response in COVID-19-related hyperinflammation and the cytokine release syndrome induced by chimeric antigen receptor T (CAR T) therapy. Furthermore, the editorial is supportive of the rationale for granulocyte macrophage colony stimulating factor (GM-CSF) pathway inhibition in the treatment of immune-mediated conditions where upstream modulation of the inflammatory cascade could be advantageous.
Kiniksa has an active investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) for a Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation. The Phase 2/3 clinical trial protocol is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mavrilimumab relative to placebo in addition to standard of care therapy in the treatment of patients with severe COVID-19 pneumonia and hyperinflammation. Additionally, an investigator-initiated placebo-controlled study in the U.S. is enrolling patients.