Wilmington-headquartered PPD Inc. (Nasdaq: PPD) has helped facilitate work as a partner with Moderna in the successful execution of the Phase 3 COVE study of its mRNA vaccine against COVID-19, according to a news release. The firm also played a role in the first federally approved treatment for the coronavirus.
Massachusetts-based Moderna Inc. announced this week the completion of the enrollment of 30,000 participants in what the firm calls its Phase 3 COVE study, officials said.
The Phase 3 study of its mRNA-1273, a vaccine candidate against COVID-19, 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), which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
"To date, more than 25,650 participants have received their second vaccination," stated the release. "Moderna will determine whether to submit a dossier to FDA requesting Emergency Use Authorization based on an assessment of whether the potential benefit of the vaccine outweighs the potential risks once the 2 months of median safety follow-up have accrued."
PPD, a global contract research organization providing drug development, laboratory and lifecycle management services, has been "essential to the successful execution to date of the COVE study," officials said in the release.
PPD also supported Moderna's Phase 2 study of mRNA-1273, stated the release.
The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate those at high risk of severe COVID-19 disease.
As of Thursday, the COVE study includes more than 7,000 people nationwide over the age of 65 and more than 5,000 people under the age of 65, but have high-risk chronic diseases that put them at increased risk of severe COVID-19, including diabetes, severe obesity and cardiac disease.
"These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study," officials said in the release.
The study also includes more than 11,000 participants from minority communities, representing 37% of the study population, including more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.
Phase 3 clinical studies of the Moderna vaccine are taking place across the nation, including in Wilmington with Trial Management Associates, which is working with two physicians, Bart Williams and Will Jones, at Wrightsville Family Practice. Moderna selected the Wilmington-based contract management organization for both Phase 2 and Phase 3 studies this year.
“Completing enrollment of the Phase 3 COVE study is an important milestone for the clinical development of mRNA-1273, our vaccine candidate against COVID-19. We are indebted to all of the participants in the study. We would also like to thank the investigators and our partners at clinical trial sites, including our partners from PPD and the NIH, as well as the dedicated Moderna team for their support in completing enrollment,” said Stéphane Bancel, CEO of Moderna, in the release. “Moderna is committed to rigorous scientific research and the highest data quality standards. We will continue to work in collaboration with regulators to advance mRNA-1273, which we hope will help defeat the COVID-19 pandemic.”
PPD was also a partner in work involving Gilead Sciences' remdesivir, or Veklury, which was recently approved for use in adult and pediatric patients ages 12 and older for the treatment of COVID-19 requiring hospitalization, according to a news release from the FDA.
Veklury is the first treatment for COVID-19 to receive FDA approval, stated the release.
“I am immensely proud of the dedication of everyone at PPD who helped Gilead achieve this significant outcome with remdesivir," said David Simmons, chairman and CEO of PPD, in a statement on the firm's website. "Together, we all are inspired by the opportunity to help our customers deliver innovative therapies. Our work with Gilead is an excellent example of how we are responding to the critical needs of our customers and our world during the pandemic.”