Optimus tests oral pills to treat Covid-19
Hyderabad: HYDERABAD-BASED Optimus Pharma has successfully completed the phase III clinical trials of the orally administered Molnupiravir capsules on patients with Mild Covid-19, according to a company release.
As per the clinical trial protocol approved, 1,218 persons with mild Covid-19 were randomised in the study in a 1:1 ratio to Molnupiravir with "standard of care" or "standard of care alone." The treatment duration was a maximum of 5 days and the total study duration was for 28 days from randomisation.
Dr D Srinivasa Reddy, MD and Chairman said that the company has internally developed the active pharmaceutical ingredient (API) and the formulations for the product and had obtained approval for conducting Phase 3 Clinical Trial. The company has approached the Drugs Controller General of India (DCGI) to seek emergency use authorisation for Molnupiravir in India.
"We are all geared up 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 per cent in test arm compared to 48.4 per cent in standard of care arm on Day 5. Day 10 and Day 14 of the treatment duration have also given excellent results wherein remaining patients have successfully achieved RT-PCR negativity," Srinivasa Reddy said.
"The trial also reveals clinical improvement in significantly high proportion of patients' 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," Srinivasa Reddy added. Optimus Pharma is committed to serving the nation and fighting back the pandemic to restore normalcy in the lives of people affected by Covid-19 at the earliest.