Kiniksa Announces Data from U.S. Investigator-Initiated Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation
- Early signal of efficacy with trends toward lower mortality and shorter duration of mechanical ventilation in patients treated with mavrilimumab –
- Data from the Phase 2 portion of Kiniksa’s adaptive design Phase 2/3 clinical trial expected in 1H 2021 -
HAMILTON, Bermuda, Dec. 22, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced data from the investigator-initiated placebo-controlled study of mavrilimumab in patients with severe COVID-19 pneumonia and hyperinflammation. Enrollment in the study was closed early to focus on Kiniksa’s registrational development program in the same patient population.
“The data showed encouraging trends of reduced mortality and duration of mechanical ventilation in patients treated with mavrilimumab, especially when considering that many patients in this placebo-controlled study had already been treated with remdesivir and/or corticosteroids,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “These data are comparable to the data from the open-label treatment protocol reported in June of 2020. We believe the totality of these two data sets supports continued evaluation of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation.”
The investigator-initiated study was a randomized, double-blind, placebo-controlled study across a consortium of U.S. academic sites, including Cleveland Clinic, University of Cincinnati, and Virginia Commonwealth University, designed to evaluate the efficacy and safety of mavrilimumab versus placebo on top of standard of care therapy in patients with severe COVID-19 pneumonia and hyperinflammation. The study enrolled 40 patients with severe COVID-19 pneumonia (all patients presented with pneumonia and hypoxia: all patients required supplemental oxygen, 50% of patients required non-invasive ventilation, none required mechanical ventilation at baseline; median PaO2/FiO2 ratio 137) and hyperinflammation (median C-reactive protein 13.1 mg/dL). Concomitant medications at baseline included corticosteroids (65% of patients) and remdesivir (75% of patients). Patients were randomized 1:1 to a single intravenous (IV) infusion of mavrilimumab 6mg/kg (n=21) or placebo (n=19) and were followed for at least 60 days.