COVID: Optimus Pharma submits phase 3 trials interim result for Molnupiravir capsules
Optimus has approached DCGI to seek Emergency Use Authorization for Molnupiravir in India, the release said.
Hyderabad: Optimus Pharma on Wednesday said that it has submitted interim result of Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild Covid infection.
With 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 here.
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 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 standard of care or standard of care alone, he said.
The treatment duration is a maximum of five days and the total study duration will be maximum for 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 percent in test arm compared to 48.4% in standard of care arm on Day 5. Day 10 and Day 14 of the treatment duration has also given excellent results wherein remaining patients have successfully achieved RT-PCR negativity, the pharma company claimed.
The trial has 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," Dr Reddy said.
Optimus has approached the Drugs Controller General of India (DCGI) to seek Emergency Use Authorization for Molnupiravir in India, the release added.
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