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Molnupiravir shows ‘promising’ results in phase 3 trials: Optimus Pharma

Our Bureau Hyderabad | Updated on July 21, 2021

‘The day 10 and day 14 of the treatment duration has also given excellent results’

The interim phase 3 results of Covid-19 drug Molnupiravir capsules have shown ‘ promising’ results, Optimus Pharma has announced on Wednesday.

“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,” the company said in a release.

The day 10 and day 14 of the treatment duration has also given excellent results wherein remaining patients have successfully achieved RT-PCR negativity, it added.

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 standard of care or standard of care alone. The treatment duration is a maximum of five days and the total study duration will be maximum for 28 days from randomisation.

According to D Srinivasa Reddy, Charman and Managing Director, Optimus Pharma, his firm has internally developed the active pharmaceutical ingredient (API) and the formulations for the product and had obtained approval for conducting Phase 3 Clinical Trial.

“Optimus is all geared to immediately begin manufacturing of Molnupiravir for Covid-19 patients in India,” he added.

“The trial also reveals clinical improvement in 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,” Reddy said.

Optimus has approached the Drugs Controller General of India (DCGI) to seek emergency use authorisation for Molnupiravir in India.

Published on July 21, 2021

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