Policy & Regulation
Ridgeback Biotherapeutics and Merck report update on Phase 2a trial of investigational oral antiviral agent
8 March 2021 -

Healthcare company Merck (NYSE:MRK) on Saturday provided an update on the preliminary results from Ridgeback Biotherapeutics LP's Phase 2a randomized, double-blind, placebo-controlled trial of the investigational oral antiviral agent, molnupiravir.

The companies presented the preliminary findings at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at another medical meeting.

According to the companies, 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. Molnupiravir is active in several models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission, as well as SARS-CoV-1 and MERS.

Based on the findings of one secondary objective from the Phase 2a study, the company announced a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection in Vero cell line culture.

This multi-centre US Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within seven days and confirmed active SARS-CoV-2 infection. The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs, concluded the partnership.

Login
Username:

Password: