The trials 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 Compared to Standard of Care alone.
The company said it has approached the Drug Controller General of India (DCGI) to seek emergency use authorization for Molnupiravir in India.
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 analog, 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 (test arm) versus standard of care alone (control arm), 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.
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 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 (2-point decrease in WHO Clinical Progression Scale) was observed in Molnupiravir group compared to standard of care
Median time to clinical improvement was as early as 8 days in Molnupiravir group compared to 12 days in standard of care alone group.
Earlier SARS CoV-2 RT-PCR negativity observed in Molnupiravir group compared standard of care. There were fewer hospital admissions in Molnupiravir group
There was no mortality in either group. All adverse events were non-serious, mild in severity, and none led to drug discontinuation. 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.