Optimus Group based in Telangana has announced the successful completion of the much-awaited Molnupiravir oral capsule phase 3 clinical trial on Thursday.
On May 18, the firm had received approval from the Drug Controller General of India (DCGI) to conduct the trial as per the recommendations of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare.
The pharmaceutical company was the first to file for phase 3 clinical trial of Molnupiravir with the Central Licensing Authority. The clinical trial partner of Optimus, JSS Research, was tasked with the execution of the trial at the grass-root level. With 29 study sites across the country, roughly covering 96% of the nation’s demographic capital, the trial not only aims to prove the superiority of Molnupiravir over the standard treatment options but also prove the drug’s efficacy across India’s gene pool diversity, said a press release.
In order to cater to the unmet medical needs of the nation for a front-end cure to SARS-CoV-2 infection, Optimus is well prepared to ensure manufacturing and distribution of Molnupiravir efficiently and effectively.
“With an indigenously developed formulation, Optimus strives to establish its belief in the Make in India initiative of the government. Our aim is to develop a cutting-edge and affordable treatment option for COVID-19 and neutralise the disease in minimum treatment duration. We are fully committed to supporting our business partners across various regions of the world who are counting on us for the supply of Molnupiravir,” said chairman and managing director D. Srinivas Reddy.
Optimus submitted the final clinical trial report which highlighted promising results: At study Day 5, 78.4% of patients in the treatment group were recorded RT-PCR negative compared to 48.2% in the placebo group. At study Day 10, 91.5% patients in the treatment group were recorded RT-PCR negative compared to 43% in the placebo group.
“These results are not only a new hope to neutralise COVID but also reinforce our belief in the CLA to ensure a fair and legitimate trial and provide the necessary support for a self-reliant pharmaceutical industry. CDSCO has emerged as a reliable licensing authority in Asia promoting innovation and strict regulatory and quality compliance in the pharmaceutical industry,” he added.
