Optimus Announces Interim Clinical Results from Phase III Clinical Trials of Molnupiravir Conducted in India
Hyderabad (Telangana) [India], July 21: Optimus Pharma on Sunday submitted the interim result of Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild Covid-19 patients. 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.
In a statement, the MD and Chairman Dr. D Srinivasa Reddy had declared that Optimus pharma has internally developed the active pharmaceutical ingredient (API) and the formulations for the product and had obtained approval for conducting Phase 3 Clinical Trial.
As per the clinical trial protocol approved, 1218 subjects with mild COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with the standard of care, or standard of care alone. The treatment duration is a maximum of 05 days and the total study duration will be a maximum of 28 days from randomisation.
“Optimus is all geared to immediately begin manufacturing of Molnupiravir 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 % in the test arm compared to 48.4% in the standard of care arm on Day 5. Day 10 and Day 14 of the treatment duration have also given excellent results wherein the remaining patients have successfully achieved RT-PCR negativity. 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,” Chairman & Managing Director – Dr. D Srinivasa Reddy said.
Optimus has approached the Drugs Controller General of India (DCGI) to seek Emergency Use Authorization for Molnupiravir in India.
Optimus Pharma is committed to serve the nation and fight back the pandemic to restore normalcy in the lives of people affected by COVID-19 at the earliest. 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.