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Drug maker Hetero on Friday announced the interim clinical results from Phase III Clinical trials of Molnupiravir in mild Covid-19 patients conducted across multiple Covid19 dedicated hospital sites across India.
Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of Covid19 being developed by Merck & Co., Inc., USA (MSD).
``The interim results from mild Covid19 patients revealed an earlier clinical improvement (2-point decrease in WHO Clinical Progression Scale) observed in Molnupiravir group compared to standard of care SOC) group,’’ the Hyderabad-based company said in a release.
``The Median time to clinical improvement as early as eight days in Molnupiravir group compared to 12 days in SOC alone group,’’ it added.
Hetero inks voluntary licensing pact with MSD for Molnupiravir
It results showed `fewer hospital admissions’ in Molnupiravir group compared to standard of care 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. Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely,’’ Hetero said.
Hetero has approached the Drug Controller General of India (DCGI) to seek Emergency Use Authorization for Molnupiravir in India.
Patients in the clinical trial were randomised to receive either Hetero’s Molnupiravir capsules 800 mg (4 x 200 mg) every 12 hours (twice daily) for five 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.
In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).
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, according to the release.
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