Optimus submits interim result of phase III clinical trials for Molnupiravir capsules

With an acute 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 pharmaceutical company said in a release.

Company Chairman and Managing Director Dr D Srinivasa Reddy said that Optimus pharma has internally developed the Active Pharmaceutical Ingredient (API) and the formulations for the product and had obtained approval for conducting a phase 3 clinical trial.

As per the clinical trial protocol approved, 1,218 subjects with mild COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with the standard of care, he said.

The treatment duration is a maximum of five days and the total study duration will be a maximum of 28 days from randomisation, Dr Reddy added.

“Optimus is all geared to immediately begin manufacturing of Molnupiravir capsules for COVID-19 patients in India. The interim results on 353 patients have shown promising results of Molnupiravir.

"The drug has been successful in reducing viral load effectively with RT-PCR negativity achieved 78.3 per cent in test arm compared to 48.4% in the standard of care arm on Day 5. Day 10 and Day 14 of the treatment duration has also given excellent results wherein the remaining patients have successfully achieved RT-PCR negativity," the pharma company claimed.

Dr Reddy said, "The trial has also revealed clinical improvement in a significantly high proportion of patient’s health. The safety of the drug has also been established with no observed side effects, co-morbidity or morbidity observed during and after the treatment duration."

The release said, Optimus has approached the Drugs Controller General of India (DCGI) to seek 'Emergency Use Authorization' for Molnupiravir in India.