Ridgeback Biotherapeutics Announces Publication of Phase 1 Double-Blind, Placebo-Controlled Study to Determine the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Molnupiravir in Healthy Volunteers
Results show drug to be generally well tolerated with pharmacokinetics exceeding plasma exposures expected to be efficacious
MIAMI--(BUSINESS WIRE)--Ridgeback Biotherapeutics, LP today announced the publication of results from its first-in-human Phase 1 study of molnupiravir (EIDD-2801/MK-4482) in healthy volunteers. The findings from this Phase 1, randomized, double-blind, placebo-controlled study were published online in the peer reviewed journal Antimicrobial Agents and Chemotherapy. The study met its primary objectives to determine the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of molnupiravir. Molnupiravir was shown to be generally well tolerated in both single and multiple ascending doses.
Of the 130 healthy volunteers who participated in the study, fewer than half reported an adverse event. The incidence of reported adverse events was higher following administration of placebo, and 93.3% of adverse events were reported as mild. There were no serious adverse events and there were no statistically significant findings from results of clinical laboratory, vital signs or electrocardiography.
The primary objective for the food effect cohort was to assess the effect of food on the pharmacokinetics on EIDD-2801 and EIDD-1931, the active antiviral ribonucleoside analog of which EIDD-2801 is a prodrug of, following a single oral dose. When administered in a fed state, there was a decrease in the rate of absorption, but no decrease in overall exposure.
Furthermore, the study met its secondary objective to define the pharmacokinetics of molnupiravir and EIDD-1931 in plasma and urine following single and multiple doses. Molnupiravir appeared rapidly in plasma, with a median time of maximum observed concentration of 1.00 to 1.75 hours, and declined with a geometric half-life of approximately 1 hour. Mean maximum observed concentration and area under the concentration versus time curve increased in a dose-proportional manner, and there was no accumulation following multiple doses. Plasma exposures exceeded expected efficacious exposures based on scaling from animal models; therefore, dose escalations were discontinued before a maximum tolerated dose was reached.
“Molnupiravir is a potential oral anti-viral for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus which causes COVID-19, and its variants. We are excited to have seen a favorable safety profile at all doses tested, with adverse events being generally mild, and not higher than seen in the placebo group,” said Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics. “Molnupiravir may address the urgent unmet need for an easily administered, oral antiviral therapy in this COVID-19 pandemic.”
“These results come on the heels of the news recently reported in Nature where therapeutic treatment of infected animals with molnupiravir twice daily significantly reduced the SARS-CoV-2 load in the upper respiratory tract and completely suppressed spread to untreated contact animals,” noted Ridgeback CEO Wendy Holman. “This study shows the potential of this therapy to hold the key to breaking community transmission. We are excited with the continued development of molnupiravir in several Ph2 and Ph3 studies.”
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally-bioavailable form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. In animal studies of two distinct coronaviruses (SARS-CoV-1 and MERS), molnupiravir has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and our partner Merck.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.