The interim results of phase 3 capsules of Molnupiravir, a Covid-19 drug, showed “promising” results, Optimus Pharma announced on Wednesday.
“The drug was successful in effectively reducing viral load with RT-PCR negativity reaching 78.3% in the test arm versus 48.4% in the standard care arm on day 5,” the company said in a report. communicated.
Day 10 and day 14 of the course of treatment also gave excellent results in which the remaining patients were successful in achieving RT-PCR negativity, he added.
In accordance with the approved clinical trial protocol, 1,218 subjects with mild Covid-19 will be randomized into the study in a 1: 1 ratio to Molnupiravir with standard management or management alone. The duration of treatment is a maximum of five days and the total duration of the study will be a maximum of 28 days from randomization.
According to Dr. Srinivasa Reddy, Charman and Managing Director of Optimus Pharma, his company has internally developed the active pharmaceutical ingredient (API) and product formulations and has obtained approval to conduct a Phase 3 clinical trial.
“Optimus is ready to immediately start manufacturing Molnupiravir for Covid-19 patients in India,” he added.
“The trial also reveals clinical improvement in a significantly high proportion of patients’ health. The safety of the drug has also been established with no side effects, comorbidity or morbidity observed during and after the course of treatment, ”said Reddy.
Optimus has contacted the Drugs Controller General of India (DCGI) to request emergency use authorization for Molnupiravir in India.