Hetero releases data of phase III clinical trails of Molnupiravir anti-viral COVID drug

Hetero, a globally renowned vertically integrated pharmaceutical organization, on Friday announced the interim clinical results from its Phase III clinical trials of Molnupiravir anti-viral drug in mild COVID-19 patients. The trials, which were conducted across multiple COVID-dedicated hospitals across India, demonstrated statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir treatment in mild COVID-19 patients. The company said it has approached the Drug Controller General of India (DCGI) to seek emergency use authorization for Molnupiravir in India.

Molnupiravir against COVID-19

In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J, the US, to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs). Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analogue, being developed globally by MSD, that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19 with demonstrated activity against SARS-CoV-2 in human airway epithelial cell cultures and potential to completely eliminate SARS CoV-2 from the body within 5 days.

Hetero had commenced a phase III, comparative, randomized, multicenter clinical trial on 1,218 mild COVID-19 patients. These clinical trials were aimed at evaluating the efficacy and safety of Molnupiravir plus standard of care versus standard of care alone, in mild Covid-19 patients with a positive SARS CoV-2 RT PCR test for Covid-19 and randomized within 5 days of onset of symptoms. 

Phase III Trials of Molnupiravir

Patients in the clinical trial were randomized to receive either Hetero's Molnupiravir capsules 800 mg (4 x 200 mg) every 12 hours (twice daily) for 5 days along with the standard of care as per the Indian Council of Medical Research (ICMR) guidelines or, in the control arm, to receive standard of care alone. The company said the interim results from 741 mild COVID-19 patients revealed encouraging outcomes. Earlier clinical improvement was observed in the Molnupiravir group compared to standard of care

Median time to clinical improvement was as early as 8 days in the Molnupiravir group compared to 12 days in a standard of care alone group. Earlier SARS CoV-2 RT-PCR negativity observed in the Molnupiravir group compared standard of care. There were fewer hospital admissions in the Molnupiravir group. There was no mortality in either group. All adverse events were non-serious, mild in severity, and none led to drug discontinuation. The most common adverse events reported were nausea, diarrhoea and headache which were resolved completely. In addition to these clinical trial studies, Hetero is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by CDSCO. The interim and final clinical results on the same will be shared in due course.