Hetero’s phase 3 trial results of Molnupiravir shows fewer hospital admissions

Hyderabad-based pharma company has approached the Drug Controller General of India to seek Emergency Use Authorization for the investigational drug in India

Hyderabad: Hetero’s interim results from phase 3 trial of Molnupiravir demonstrated statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with treatment in mild Covid-19 patients compared to standard of care (SOC) alone, the company said.

The Hyderabad pharma company has approached the Drug Controller General of India to seek Emergency Use Authorization for the investigational drug in India.

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In April this year, the company 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).

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 with a potential to completely eliminate SARS CoV-2 from the body within five days.

“Hetero had commenced a phase-III, comparative, randomised, multicentre clinical trial on 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 randomised within five days of onset of symptoms,” the company said.

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.

Early clinical improvement

The interim results from mild Covid-19 patients revealed earlier clinical improvement in Molnupiravir group compared to standard of care. Median time to clinical improvement as early as eight days in Molnupiravir group compared to 12 days in SOC alone group.

Also, earlier SARS CoV-2 RT-PCR negativity observed in Molnupiravir group compared to standard of care. Fewer hospital admissions in Molnupiravir group compared to standard of care alone over 14 days of observation.

Hetero said, “There was no mortality in either of the 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 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, the company said.

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