English Health

Optimus PharmaSeeks Emergency Approval to Conduct Phase 3 Clinical Trial of Molnupiravir for COVID-19 in India

April 27, 20214 min read dsprime

Hyderabad [Telangana], April 27: Dr. D. Srinivas Reddy, Chairman, and CEO of Optimus Pharma announced that they have filed for seeking emergency approval for Phase 3 Clinical Trial from the Drugs Controller General of India. Once the approval is granted for Phase 3 Clinical Trial, we would be extensively accelerating the manufacturing of our in-house developed generic version of Molnupiravir for making it available in the Indian market as soon as possible. Optimus Pharma is committed to halting the pandemic across the nation and ensuring immediate relief to all those who have been infected with the highly virulent SARS-CoV-2.

Optimus Pharma is pleased to announce the development of oral Molnupiravir on the fast lane. Optimus Pharma is becoming a key player in the fight against the COVID-19 pandemic in India has already achieved very high production levels of Favipiravir one of our flagship drugs for COVID-19 infection. In a bid to develop and diversify our anti-viral portfolio especially against SARS-CoV-2, we are here with yet another promising drug to compensate for the lack of antiviral drugs in the market further diversifying our antivirals portfolio. In hindsight of the raging second wave, Molnupiravir has been developed for non-hospitalized mild to moderate infections of SARS-CoV-2. Optimus Pharma is aggressively pushing for achieving scalability for 800mg dose of the drug.

Our available pre-clinical data on Molnupiravir already demonstrated that there were no adverse clinical signs and mortality observed in any of the treatment groups, as compared to the control group of animals with high efficacy and thereby effectively neutralizing virulence of the SARS-CoV-2 virus in the test group as compared to control group.

The drug is effective against a variety of viruses that use an RNA-dependent RNA polymerase (RdRp), as is the case with SARS-CoV-2 which is directly responsible for the transcription of Viral m-RNA of the virus in the infected subject. Early in vitro tests of Molnupiravir on SARS-CoV-2 revealed a steady decrease in virus output that was proportional to the dose of Molnupiravir used. Since the RdRp of SARS-CoV-2 and SARS-CoV, which the drug was designed to treat, has 99.1% nucleotide similarity hence, this was possible. Repeated drug exposure quickly neutralized virus populations, ensuring that none of the random mutations mediate drug resistance. As the drug is introduced in higher amounts, the titer levels and genome output of SARS-CoV-2 decrease exponentially.

It has been observed that Molnupiravir is only marginally successful in preventing extreme SARS-CoV-2 infection that is severe cases of the infection. This might have been the reason for their withdrawal and continue the trial only with non-hospitalized patients that are subjects with mild to moderate infection. We aim to do the same and establish its efficacy in the same treatment group.

Phase 2 Clinical Trial study on enrolled 202 non-hospitalized adults is already made available by the innovator of the molecule. Virological analysis was characterized by a marked decrease in positive viral culture in subjects who received Molnupiravir (all doses) relative to placebo – at day 5: 0% (0/47) for Molnupiravir and 24% (6/25) for placebo. Furthermore, the secondary objective for a faster decrease in infectious virus among people with early COVID-19 who were treated with Molnupiravir is encouraging and Phase 3 Clinical Trials are warranted for checking the efficacy of the molecule across demographics, particularly as the SARS-CoV-2 virus continues to spread and evolve globally.

Unlike the current drugs being administered intravenously, Molnupiravir is administered orally. This makes it a promising drug to halt the disease progression in the early stages as well as mount a powerful response against moderate infection levels. The fact that this molecule can be consumed as an orally administered drug in the form of an 800mg capsule renders a maverick advantage to achieve scalability in terms of upscaling from gm scale to multi-ton levels in a short time frame, thereby ensuring availability in the Indian market at a comparatively exponential scale. In vitro assays indicate that it is significantly more effective than the drugs being used currently, and the safety profile appears to be satisfactory.