Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.
The company had previously announced on June 11 that it expected to begin the Phase 3 trial at some point this month. At that point, it had already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed, having previously reported positive results in May for the Phase 1 study.
“We are pleased to have started the Phase 3 COVE study,” Moderna CEO Stephane Bancel said in a news release. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
Moderna’s Phase 3 study complies with FDA guidance as a randomized, placebo-controlled trial expected to include 30,000 U.S. participants testing the mRNA-1273 candidate in a dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19, with key secondary endpoints including prevention of severe COVID-19 (defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 (the virus causing COVID-19) regardless of symptomology. Primary efficacy analysis will be based on the number of participants with symptomatic COVID-19 disease.
The company is working closely with BARDA and the NIH to conduct the Phase 3 COVE study under the U.S. government’s “Operation Warp Speed” program to produce a successful vaccine at scale by the end of 2020. It is also collaborating with PPD for drug development, laboratory and lifecycle management services, while the company last month announced a collaboration for large-scale, commercial fill-finish manufacturing of its vaccine candidate with Catalent (NYSE:CTLT).
In total, Moderna has selected nearly 100 clinical research sites for the study. Moderna says it remains on track to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.
Having priced a $1.3 billion public offering on the back of the positive results from Phase 1, Moderna’s stock continues to rise with today’s news, trading up 6.4% at $77.90 per share in midday trading today.
MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.3% today.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease