Optimus Pharma received DCGI nod for conducting Phase III clinical trials for orally administered Molnupiravir capsules on patients with mild to moderate COVID-19 patients. After developing the active pharma ingredient (API) and the formulations for the product, Optimus Pharma had filed for clinical trials with the DCGI.
As per the clinical trial protocol approved, 2500 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care or standalone standard supportive care. The treatment duration is a maximum of 05 days and the total study duration will be maximum for 29 days from randomisation, said the company.
“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 and MD, Optimus Pharma.
In a previous press release, the company had informed that Molnupiravir demonstrated highly promising results in reducing viral load to 0.0 per cent in merely five days of treatment duration. Based on the completed phase 2 part clinical studies, the proposed dosage is 800 mg twice daily which significantly reduces viral culture in infected patients and prevents ARDS.