Merck has begun its rolling submission to Health Canada for its experimental antiviral agent, molnupiravir, as a potential COVID-19 therapy.
Molnupiravir is being developed by Merck in partnership with Ridgeback Biotherapeutics, and is an oral formulation of a potent ribonucleoside analogue with antiviral activity against the SARS-CoV-2 virus.
The rolling submission was accepted by Health Canada under the Interim Order of the Minister of Health, which permits the review of initial safety, quality, and efficacy findings while late-stage studies are underway.
When available, results from the molnupiravir development programme, will be submitted to Health Canada and a decision will following the review of all required evidence.
The antiviral agent was invented by Emory University’s not-for-profit biotechnology company, Drug Innovations at Emory.
In March this year, Merck and Ridgeback reported preliminary results from a Phase IIa trial of molnupiravir for Covid-19 and a Phase II/III trial is underway.
The randomised, placebo-controlled, double-blind, multi-centre MOVe-OUT trial is analysing oral doses of the drug in 1,850 non-hospitalised Covid-19 patients aged 18 years or above.
In various preclinical models, including for prophylaxis, treatment and prevention, molnupiravir had demonstrated activity against SARS-CoV-2. The drug was also observed to be active in SARS-CoV-1 and MERS models.
Kat Jenkins
This is a syndicated feed from Pharmafile
