Optimus Pharma on May 19 said it has received the Drug Controller General of India's (DCGI) go-ahead for conducting Phase-III clinical trials for orally administered Molnupiravir capsules on mild to moderate COVID-19 patients.
Optimus Pharma said it has internally developed the active pharmaceutical ingredient (API) and the formulations for the product it had filed for clinical trials with the DCGI.
As per the clinical trial protocol approved, as many as 2,500 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care versus standalone standard supportive care.
The treatment duration is a maximum of 5 days and the total study duration will be a maximum of 29 days from randomisation, the release said.
Moneycontrol has learnt from sources that while Molnupiravir formulation is protected by patents, its API isn't. MSD (US Merck) last month has signed with voluntary licensing agreements with Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries.
“Optimus is all geared to immediately begin clinical trials on Molnupiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients,” said Dr D Srinivas Reddy, Chairman & Managing Director of Optimus Pharma.
Molnupiravir demonstrated highly promising results in reducing viral load to almost zero in merely 5 days of treatment duration.
Based on completed phase-2 part clinical studies, proposed dosage is 800 mg twice daily which significantly reduces viral culture in infected patients not progressing into acute respiratory distress syndrome.