Hetero announces interim clinical results from phase III clinical trials of Molnupiravir conducted in India
- Phase 3 Trial Demonstrates 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
- Hetero 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., USA (NYSE: MRK), 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 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 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 interim results from mild COVID-19 patients (N=741) revealed the following encouraging outcomes:
- Earlier clinical improvement (2-point decrease in WHO Clinical Progression Scale) observed in Molnupiravir group compared to standard of care (Day 5 (63.43% vs 22.33%; p=<0.0001), Day 10 (78.96% vs 49.49%; p=<0.0001) and Day 14 (81.55% vs 73.22%; 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% vs 26.07%; p=<0.0001) Day 10 (94.03% vs 57.20%; p=<0.0001) and Day 14 (97.01% vs 85.21%; p=<0.0001)).
- Fewer hospital admissions in Molnupiravir group compared to standard of care alone (7 (1.89%) Vs 23 (6.22%) p= 0.0027) over 14 days of observation.
- There was no mortality in either groups. All adverse events were non-serious, mild in severity, and none led to drug discontinuation. The most common adverse events reported were nausea, diarrhea, and headache which were resolved completely.
