Hyderabad: Phase III Clinical trials of Molnupiravir drug begins

Hyderabad: Molnupiravir Phase III clinical trials was launched on Friday in the city-based Yashoda Hospital in Somajiguda in association with Natco Pharma who received DCGI approval for conducting the phase III clinical trials for oral administration of Molnupiravir capsules for patients with mild and moderate Covid-19 symptoms.

Announcing the commencement of the trials, Dr Lingaiah Amidalya, medical director of the hospital, said "It is a privilege to be the first hospital in India chosen for the Phase III of the clinical trials, we hope that the trial is a success proving itself to be a game-changer, if patients can be treated with Molnupiravir in the mild stage of the disease, the transmission of Covid-19 can be controlled and further worsening of the disease can be prevented at large scale, thus the disease burden on the healthcare system as well as the society could be reduced, with significant implications on the financial burden of the common man and their out-of-pocket expense."

The clinical trials at Yashoda Hospital will entail the Covid patient volunteers to take 400 mg twice a day without being admitted to the hospital since it is an OPD (out-patient department) based clinical trial, and have reinteractions with their physicians on day 5, day 10 and day 15 for their follow at the hospital.

Molnupiravir is a prodrug of the active antiviral ribonucleoside analog of β-d-N4-hydroxycytidine. Its activity against SARS-CoV-2 is by inhibition of RNA-dependent-RNA polymerase. Molnupiravir leads to errors in the viral RNA sequence, stopping viral replication, shortening infection, and limiting disease transmission.

Scientists at Georgia University, United States of America have anticipated the tablet to take effect within 24 hours of the dose and that the oral administration of the tablet on Covid severe patients will help reduce the severity of the symptoms. Pre-clinical (animal) studies have found that Molnupiravir has remarkably reduced SARS-CoV-2 load and was found to have completely suppressed the spread of disease from animal to animal, and the virus multiplication development had stopped.

In a Phase-I clinical trial conducted in the United Kingdom, Molnupiravir was deemed to be safe and well-tolerated up to 800 mg twice a day for 5 days in healthy trial subjects. In the Phase-II clinical trials conducted in the USA, all patients who received Molnupiravir for 5 days were found to have a negative SARS-CoV-2 culture after the 5-day treatment duration.