Final analysis inclusive of the 60-day safety update in the randomized placebo-controlled study demonstrated CERC-002 was statistically significant in reducing respiratory failure and mortality at Day 28 in patients hospitalized with COVID-19 associated pneumonia and mild to moderate acute respiratory distress syndrome (ARDS), the primary endpoint, (p=0.044)

Efficacy was highest in patients over the age of 60, the population most vulnerable to severe complications and death with COVID-19 infection.

At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed.

Results were observed on top of standard of care including high dose steroids (>90%) and remdesivir (>65%).

Cerecor has applied for FDA Breakthrough Therapy and Fast Track Designations, and plans to meet with FDA to discuss potential path to Emergency Use Authorization

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