Optimus Pharma on Wednesday received DCGI nod for conducting phase-III clinical trials for orally-administered Molnupiravir capsules on patients with mild-to-moderate Covid-19 patients.
With 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, the company said.
Optimus pharma said having internally developed the Active Pharmaceutical IngrOptimus Pharma Gets DCGI Nod for Conducting Phase-III Clinical Trials for Molnupiravir on Mild-to-Moderate Covid Patientsedient (API) and the formulations for the product, it had filed for clinical trials with the DCGI. The regulator gave nod for conducting the trial on mild to moderate patients.
As per the clinical trial protocol approved, 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 or standalone standard supportive care. The treatment duration is a maximum of five days and the total study duration will be 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,” the company’s Chairman & Managing Director Dr D Srinivas Reddy said.
Earlier, the company stated that Molnupiravir demonstrated highly promising results in reducing viral load to 0.0% in merely five days of treatment duration. Based on completed phase-II part clinical studies, 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 of Anti-Viral drugs against Sars-CoV-2 in the Indian market,” Reddy added.