Hetero announces interim clinical results of Molnupiravir in COVID patients in India
Hyderabad: 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) , 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, Hyderabad-based Pharmaceutical company said in a release here.
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.
While referring the interim results from mild COVID-19 patients, it said there was no mortality in either groups. 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 the clinical trial studies, Hetero is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by CDSCO.
Hetero company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.
It has 36 state-of-the-art manufacturing facilities strategically located worldwide, which has been approved by top pharma regulatory bodies of the world.
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