Optimus interim phase 3 data for Molnupiravir shows 78.3% efficacy
The interim results on 353 patients showed that the drug has been successful in reducing viral load effectively with RT-PCR negativity.
Hyderabad: Hyderabad-based Optimus Pharma’s interim results of phase III clinical trials for orally administered Molnupiravir capsules on patients with mild Covid-19 patients showed reduced viral load and 78.3 per cent efficacy. The company said it has submitted the data to the Indian drugs regulator Drugs Controller General of India (DCGI) on Sunday.
Optimus chairman and managing director Dr D Srinivasa Reddy said the company has developed the active pharmaceutical ingredient and the formulation for the drug and had obtained approval for conducting phase 3 clinical trials.
The interim results on 353 patients showed that the drug has been successful in reducing viral load effectively with RT-PCR negativity, achieving 78.3 per cent in the test arm compared to 48.4 per cent in standard of care arm on Day 5.
“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,” he added.
As per the trial protocol, 1,218 subjects with mild Covid-19 are being 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 study duration is 28 days.
Optimus has approached the DCGI to seek Emergency Use Authorization for Molnupiravir in India. The company said it is prepared to immediately begin production of the drug.
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