Optimus Pharma gets DCGI nod to conduct Phase-3 trial of COVID-19 antiviral drug Molnupiravir

Optimus Pharma has internally developed the active pharmaceutical ingredient and the formulations for the product it had filed for clinical trials with the DCGI.

Viswanath Pilla
May 19, 2021 / 06:03 PM IST

Molnupiravir demonstrated highly promising results in reducing viral load to almost zero in merely 5 days of treatment duration. (Representative image)

 
 
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Optimus Pharma on May 19 said it has received the Drug Controller General of India's (DCGI) go-ahead for conducting Phase-III clinical trials for orally administered Molnupiravir capsules on mild to moderate COVID-19 patients.

Optimus Pharma said it has internally developed the active pharmaceutical ingredient (API) and the formulations for the product it had filed for clinical trials with the DCGI.

As per the clinical trial protocol approved, as many as 2,500 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care versus standalone standard supportive care.

The treatment duration is a maximum of 5 days and the total study duration will be a maximum of 29 days from randomisation, the release said.

Moneycontrol has learnt from sources that while Molnupiravir formulation is protected by patents, its API isn't. MSD (US Merck) last month has signed with voluntary licensing agreements with Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries.

COVID-19 Vaccine

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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“Optimus is all geared to immediately begin clinical trials on Molnupiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients,” said Dr D Srinivas Reddy, Chairman & Managing Director of Optimus Pharma.

Molnupiravir demonstrated highly promising results in reducing viral load to almost zero in merely 5 days of treatment duration.

Based on completed phase-2 part clinical studies, proposed dosage is 800 mg twice daily which significantly reduces viral culture in infected patients not progressing into acute respiratory distress syndrome.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
TAGS: #Business #Companies #coronavirus
first published: May 19, 2021 06:03 pm