Cerecor Has Successful Phase 2 Data on Antibody in Patients Hospitalized with COVID-19 ARDS

 

• COVID-19 ARDS patients treated with a single dose of the anti-LIGHT monoclonal antibody CERC-002 demonstrated robust improvement in the primary endpoint (proportion of patients alive and free of respiratory failure over the 28-day study period) compared to placebo (n=62, odds ratio [OR] = 2.62, p=0.059)
• A prespecified subgroup analysis of patients 60 years of age showed that CERC-002 treatment led to a greater than 3-fold increase in likelihood of avoiding respiratory failure and death compared to placebo (n=33, OR = 3.38, p=0.054)
• 28-day mortality was reduced by approximately 50% in patients treated with CERC-002 (3 patients) vs. placebo (6 patients). There were a total of 4 COVID-19 related deaths in patients on CERC-002 vs. 9 on placebo as of December 2020. These data will be updated and analyzed at the 60-day timepoint
• Importantly, CERC-002 showed activity on top of corticosteroids in COVID-19 ARDS (>90% of patients in the trial received corticosteroids and >60% received remdesivir)
• CERC-002 dramatically and rapidly reduced serum free-LIGHT levels
• CERC-002 was well tolerated with no drug related SAEs and no clinically meaningful differences in immunosuppression or other SAEs between CERC-002 and placebo
• The company intends to meet with the FDA and believes that these data support the initiation of a registration trial and filing for Breakthrough Therapy Designation. Additionally, the company is continuing its program in severe pediatric-onset Crohn’s disease and is exploring the applicability of CERC-002 in non-COVID-19 ARDS
• http://www.globenewswire.com/news-release/2021/01/05/2153315/0/en/Cerecor-Announces-Successful-Proof-of-Concept-Data-for-CERC-002-a-Unique-LIGHT-Neutralizing-Antibody-in-Patients-Hospitalized-with-COVID-19-ARDS.html