Benzinga | Apr 12, 2021 07:31AM EDT

Kiniksa Announces Announces Mavrilimumab Phase 2 Trial In Non-Mechanically Ventilated Severe COVID-19 Patients Achieved Primary Efficacy Endpoint

-- Primary endpoint achieved: the proportion of patients alive and free of mechanical ventilation at Day 29 was 12.3 percentage points higher with mavrilimumab versus placebo (p=0.1224 met predefined statistical threshold of p<0.2) --

-- 65% reduction in risk of mechanical ventilation/death with mavrilimumab versus placebo (p=0.0175) --

-- 61% reduction in risk of death with mavrilimumab versus placebo (p=0.0726) --

-- Clinical improvement was observed on top of steroids and/or antivirals --

-- Enrollment in the Phase 3 portion of the trial ongoing --

HAMILTON, Bermuda, April 12, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced the Phase 2 portion of the Phase 2/3 trial of mavrilimumab in non-mechanically-ventilated patients (Cohort 1) with severe COVID-19 pneumonia and hyperinflammation achieved its primary efficacy endpoint of the proportion of patients alive and free of mechanical ventilation at Day 29. Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFR?).

"These data suggest that mavrilimumab may be a transformational treatment option for patients with severe pneumonia due to hyper-inflammatory syndromes, including COVID-19," said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "Additionally, they reinforce our belief in the potential broad utility of mavrilimumab, which has demonstrated positive clinical data across three indications: giant cell arteritis, rheumatoid arthritis, and severe COVID-19. We are engaged with various government agencies to potentially secure resources to help bring mavrilimumab to patients as soon as possible."

The Phase 2/3 trial is a global, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mavrilimumab treatment in adults hospitalized with severe COVID-19 pneumonia and hyperinflammation.

In the Phase 2 portion of the trial, patients were enrolled into 2 cohorts: non-mechanically ventilated patients (Cohort 1) 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. There was a seamless transition in the enrollment of patients in both cohorts from the Phase 2 into the Phase 3 portions of the trial.

In the non-mechanically ventilated cohort (Cohort 1), 116 patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation were enrolled across sites in the United States, Brazil, Chile, Peru, and South Africa. 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. Key secondary endpoints included Time to Two-Point clinical improvement on the National Institute of Allergy and Infectious Diseases (NIAID) scale, Time to Return to Room Air, and Mortality at Day 29. The prespecified evidentiary standard for Phase 2 endpoints was a 2-sided alpha value of 0.2, without adjustment for multiplicity.

Baseline demographics were balanced across treatment arms: the population was ethnically/racially diverse (43% non-white), 49% were obese (body mass index ? 30), and 29% were older than 65 years. All patients received localstandard of care therapy: 96% received corticosteroids/dexamethasone and 29% received antivirals/remdesivir.