American pharmaceutical behemoth Merck (NYSE:MRK) and Ridgeback Biotherapeutics LP disclosed preliminary findings from Phase 2a double-blind, placebo-controlled, randomised trial for evaluating the safety, tolerability, and efficacy of molnupiravir to eliminate SARS-CoV-2.
On 6 March 2020, the companies reported findings from one secondary objective from the Phase 2a clinical trial. The trial demonstrated a reduction in time of isolation of coronavirus in participants having symptomatic SARS-CoV-2 infection.
The companies disclosed that molnupiravir, an investigational oral antiviral agent, demonstrated a quicker reduction in the coronavirus in phase 2a trial among participants having early COVID-19 symptoms.
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Molnupiravir is an orally-bioavailable, investigational form of a potent analog of ribonucleoside that prevents the replication of various RNA viruses including SARS-CoV-2.
CMO and senior VP and global clinical development head of Merck Research Laboratories, Dr Roy Baynes, commented:
The lead investigator of the study and a professor of medicine at the University of North Carolina, Dr William Fischer, said that the study’s findings are promising. He further added-
Moreover, the companies disclosed that findings from the primary efficacy as well as safety endpoints, including additional secondary objectives, will be presented at an upcoming medical meeting.
Phase 2a clinical trial details
- Phase 2a study is a multi-center US-based clinical trial that enrolled 202 non-hospitalised adults who had COVID-19 signs or symptoms within seven days and were confirmed active SARS-CoV-2 infection.
- The trial’s primary objective was the decline in time to viral negativity determined by RT-PCR (reverse transcriptase polymerase chain reaction) analysis.
- The study results remain blinded, and companies will share at a later date.
- The duo updated the market that other Phase 2 and Phase 2/3 clinical trials are underway.
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In addition to the ongoing clinical trials, Merck has conducted a thorough nonclinical program for the safety profile characterisation of molnupiravir.