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Hetero announces interim clinical results from Phase III clinical trials of Molnupiravir conducted in India

ANI | Updated: Jul 09, 2021 11:51 IST

Hyderabad (Telangana) [India], July 9 (ANI): Hetero, a globally renowned vertically integrated pharmaceutical organization, on Friday announced the interim clinical results from Phase III clinical trials of Molnupiravir in mild Covid-19 patients conducted across multiple COVID-19 dedicated hospital sites across India.

In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).
As per the official release by Hetero, 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 mild Covid-19 patients (N=1218). 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 interim results from mild COVID-19 patients (N=741) revealed encouraging outcomes.
Earlier clinical improvement (2-point decrease in WHO Clinical Progression Scale) observed in the Molnupiravir group compared to standard of care (Day 5 (63.43 percent vs 22.33 percent; p=<0.0001), Day 10 (78.96 percent vs 49.49 percent; p=<0.0001) and Day 14 (81.55 percent vs 73.22 percent; p=0.0150))
Median time to clinical improvement as early as 8 days in Molnupiravir group compared to 12 days in SOC alone group (p=0.0001)
Earlier SARS CoV-2 RT-PCR negativity observed in Molnupiravir group compared standard of care (Day 5 (77.35 percent vs 26.07 percent; p=<0.0001) Day 10 (94.03 percent vs 57.20 percent; p=<0.0001) and Day 14 (97.01 percent vs 85.21 percent; p=<0.0001)).
Fewer hospital admissions in the Molnupiravir group compared to standard of care alone (7 (1.89 percent) vs 23 (6.22 percent) p= 0.0027) over 14 days of observation.
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 the above 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. (ANI)