Optimus Pharma on Sunday submitted the interim result of Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with mild Covid-19 symptoms.
Hyderabad (Telangana): Optimus Pharma on Sunday submitted the interim result of Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with mild Covid-19 symptoms.
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.
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