Optimus Pharma gets DCGI nod for conducting Phase III Clinical Trials for Molnupiravir on patients with mild and moderate COVID-19 infection
Hyderabad (Telangana) [India], May 19: Optimus Pharma on Tuesday received DCGI nod for conducting Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild and Moderate Covid-19 symptoms. With a severe shortage of antiviral drugs in the market against the SARS-CoV-2 infection, it is imperative that more drugs with potent antiviral activity against SARS-CoV-2 be introduced.
Optimus pharma said having internally developed the active pharmaceutical ingredient (API) and the formulations for the product, it had filed for clinical trials with the DCGI. The regulator gave a nod for conducting the trial on mild and moderate patients on May 18 2021.
As per the clinical trial, protocols approved, a total of 2500 subjects in both mild and 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 a maximum for 29 days from randomisation, the release said.
“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,” Chairman & Managing Director – Dr. D Srinivas Reddy said.
In the previous press release, the company stated that Molnupiravir demonstrated highly promising results in reducing viral load to 0.0% in merely 5 days of treatment duration. Based on completed phase 2 part clinical studies, the proposed dosage is 800mg twice daily which significantly reduces viral culture in infected patients not progressing into ARDS.
Optimus Pharma is one of the largest manufacturers of the highly successful SARS-CoV-2 antiviral drug without compromising on quality as is the case with Favipiravir (sold under the brand – FAVICOVID). The company aims to do the same with Molnupiravir to cater to the rising demand for Anti-Viral drugs against SARS-CoV-2 in the Indian market.
With the cooperation of the government and our stakeholders, and a special thanks to the Subject Expert Committee of the CDSCO for their valuable contribution and their recommendations to the project, we hope to deliver the product in India by leveraging our solid distribution strength across the country.