Kiniksa Reports Interim Data from Phase 2/3 Trial of Mavrilimumab in Non-Mechanically Ventilated Severe COVID-19 Patients

Kiniksa Reports Interim Data from Phase 23 Trial of Mavrilimumab in Non-Mechanically Ventilated Severe COVID-19 Patients

Kiniksa announced results from the Phase 2 portion of a phase 2/3 trial of mavrilimumab in non-mechanically ventilated patients (Cohort 1) with severe COVID-19 pneumonia and hyperinflammation. The primary efficacy endpoint was achieved, with the proportion of patients alive and free of mechanical ventilation at Day 29 higher with mavrilimumab treatment versus placebo. Enrollment is currently underway in the phase 3 portion of the trial.

In the Phase 2 portion of the global, randomized, double-blind, placebo-controlled trial, patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation were enrolled into 2 cohorts: non-mechanically ventilated patients (Cohort 1; n=116) requiring supplemental oxygen to maintain SpO2 ≥ 92%; and mechanically ventilated patients (Cohort 2) for whom mechanical ventilation was initiated within 48 hours prior to randomization. Patients were randomized in a 1:1:1 ratio to receive a single intravenous (IV) dose of mavrilimumab 10 mg/kg, 6 mg/kg, or placebo. The primary efficacy endpoint was the proportion of patients alive and free of mechanical ventilation at Day 29. 

Non-mechanically ventilated patients (Cohort 1) treated with mavrilimumab demonstrated a reduction in mechanical ventilation and death at Day 29 pooled across dose levels. The proportion of patients alive and free of mechanical ventilation at Day 29 was 12.3 percentage points higher in mavrilimumab recipients (86.7%) compared to placebo recipients (74.4). Mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death through Day 29. Day 29 mortality was 12.5 percentage points lower in mavrilimumab recipients (8%) compared to placebo recipients (20.5%). Mavrilimumab recipients experienced a 61% reduction in the risk of death through Day 29. 

Kiniksa indicated it is discussions with the U.S. FDA and other government agencies to identify pathways, including potential Emergency Use Authorization, for accelerated availability of mavrilimumab as a therapeutic option for severe COVID-19 patients.

About mavrilimumab

Mavrilimumab is a fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα).

Responses