NATCO starts Phase-III Clinical Trial of Molnupiravir capsules for Covid-19 treatment with Yashoda Hospitals

Natco Pharma Limited on Friday, May 21, 2021, announced that it has initiated a Phase-III clinical trial of Molnupiravir capsules in India. Its first patient was dosed today in Yashoda Hospitals, Hyderabad.

Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.

Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir Capsules in mild COVID-19 patients. NATCO's clinical trial is planned in 32 hospitals across India. A few established hospitals locally include Yashoda Hospitals, Gleneagles Global Hospitals, KIMS Hospital in Secunderabad and Vizag, and Excel Hospital, where the trial is being conducted.

Announcing the commencement of the trials, Dr. Lingaiah Amidalya, Medical Director of Yashoda Hospitals stated that, "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 it 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 a large scale. Thus, the disease burden on the healthcare system as well as the society could well be reduced, with significant implications on the financial burden of the common man and their out of the pocket expense."

Hyderabad based Yashoda Hospitals in a release said, "The Clinical trials at Yashoda Hospitals will entail the COVID patient volunteers to take 400 mg twice a day without being admitted in the hospital since it is an OPD (out-patient department) based clinical trial and have regular interactions with their physicians on Day 5, Day 10 and Day 15 for their follow up cycle at the Hospital."

Molnupiravir is a prodrug of the active antiviral ribonucleoside analogue 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 USA 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.