Kiniksa Announces Data from U.S. Investigator-Initiated Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation - Seite 2

Data showed an early signal of efficacy, with trends toward clinical improvement as well as lower mortality and shorter duration of mechanical ventilation in patients treated with mavrilimumab on top of corticosteroids, including dexamethasone, and/or remdesivir.

• There was a 20.5% relative increase in the primary efficacy endpoint, the proportion of patients alive and off supplemental oxygen at Day 14 (mavrilimumab: 57.1% [n=21]; placebo: 47.4% [n=19]; nominal p=0.536).
• There was a 20.7% relative increase in the secondary efficacy endpoint, the proportion of patients alive and without respiratory failure at Day 28 (mavrilimumab: 95.2%; placebo: 78.9%; nominal p=0.172).
• There was 1 death (4.8%) in the mavrilimumab arm by Day 28, compared to 3 deaths (15.8%) in the placebo arm (nominal p=0.222). By Day 60 there was 1 death (4.8%) in the mavrilimumab arm, compared to 4 deaths (21.1%) in the placebo arm (nominal p=0.108).
• While the percentage of patients who progressed to mechanical ventilation was similar between treatment arms (mavrilimumab: 23.8% [n=5]; placebo: 21.1% [n=4]), the median (interquartile) duration of mechanical ventilation was shorter in the mavrilimumab arm (12 [9.0, 18.0] days) compared to the placebo arm (17 [11.0, 24.5] days). Additionally, 4 of the 5 patients who progressed to mechanical ventilation in the mavrilimumab arm had recovered by Day 28, whereas all patients in the placebo arm who progressed to mechanical ventilation had died by Day 28.
• There was no difference in serious adverse events between the mavrilimumab arm and the placebo arm.
  
  

“In the context of the evolving standard of care, the data from this trial in severe COVID-19 pneumonia and hyperinflammation are encouraging,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “While vaccination is expected to be the mainstay of COVID-19 prevention, we believe there will remain an unmet need for effective therapeutics to treat patients who develop severe hyperinflammation. I look forward to the results of the larger Kiniksa-sponsored trial of mavrilimumab in this patient population.”

Kiniksa is enrolling the Phase 2 portion of an adaptive design, placebo-controlled Phase 2/3 clinical trial in severe COVID-19 pneumonia and hyperinflammation. The company expects data from the Phase 2 portion of the trial in the first half of 2021.

About the Investigator-Initiated Placebo-Controlled Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation in the U.S.
The investigator-initiated Phase 2 trial was a randomized, double-blind, placebo-controlled study in the U.S. designed to evaluate the efficacy and safety of mavrilimumab versus placebo on top of standard of care therapy in the treatment of severe COVID-19 pneumonia and hyperinflammation. Standard of care therapy included, but was not limited to, anti-viral treatment and/or supportive care. The trial enrolled 40 patients across a consortium of academic sites, including Cleveland Clinic, University of Cincinnati, and Virginia Commonwealth University. Patients were randomized 1:1 to mavrilimumab to a single IV infusion of mavrilimumab 6 mg/kg or placebo. The primary endpoint was the proportion of patients alive and off of supplemental oxygen at Day 14. For more information, refer to ClinicalTrials.gov Identifier: NCT04399980.