New Delhi: Hyderabad-based pharmaceuticals company Hetero, announced Friday that the interim analysis of the phase-3 trials of the antiviral Covid drug being manufactured by it in India, Molnupiravir, has shown promising results.
The company said that the drug — an oral antiviral — when administered to mild Covid patients, helped them recover faster, in comparison to those who received standard of care (SOC, the treatment process followed by a doctor based on the patient’s requirements, illness and clinical circumstances) treatment alone.
The company claimed in a statement that the phase-3 trials demonstrated “statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR (test results) with Molnupiravir treatment in mild Covid-19 patients, compared to standard of care alone.”
The company has now approached the Drugs Controller General of India (DCGI) to seek emergency use authorisation for the drug in India.
According to a press statement, the company conducted phase-III, comparative, random, multicentre clinical trials on 1,218 mild Covid patients, to evaluate the efficacy and safety of administering Molnupiravir, along with the SOC given to Covid patients, in comparison to SOC treatment alone. These trials were done on patients within five days of onset of symptoms.
Patients in the clinical trial were randomly selected to receive either Molnupiravir capsules of 800 mg strength (four capsules of 200 mg strength) every 12 hours (twice daily) for five days, along with SOC, as per the Indian Council of Medical Research (ICMR) guidelines, or to receive SOC alone.
Molunupiravir is being developed by American pharma giant MSD, in collaboration with an American biotechnology firm, Ridgeback Biotherapeutics. The drug is a potent ribonucleoside analog (known to block RNA viruses associated with influenza-like diseases) that inhibits the replication of multiple RNA viruses (those that have ribonucleic acid as its genetic material), including SARS-CoV-2, the causative agent of Covid.
In April, 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) across the world. The other Indian manufactures that the American company had tied up with at the time include Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals and Sun Pharmaceutical. Hetero is the first company to announce results in India for phase-3 trials of the drug.
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‘Median time to recovery is eight days’
The results of the investigational drug showed early clinical improvement. The company said that on the fifth day (of onset of symptoms) they observed clinical improvement in 63.43 per cent of those in the drug group, compared to only 22.33 per cent of those who received SOC alone.
On the tenth day, 78.96 per cent of those who received Molnupiravir showed improvement, in comparison to 49.49 per cent of those who were not administered the medicine, and on the fourteenth day 81.55 per cent of those who received the medicine showed improvement, compared to 73.22 per cent of those who got SOC alone.
“Median time to clinical improvement was seen (to be) as early as eight days in Molnupiravir group, compared to 12 days in SOC alone group,” the company said.
The company said that over a 14-day observation period, they found fewer hospital admissions among the group that received Molnupiravir, compared to those on standard of care alone — 7 per cent versus 23 per cent, respectively.
“There was no mortality in either group. All adverse events (from the drug use) 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,” the release stated.
Hetero has also said that it is undertaking a separate Molnupiravir study on moderate Covid patients, which has been approved by the Central Drugs Standard Control Organisation (CDSCO). “The interim and final clinical results of the same will be shared in due course,” it said.
(Edited by Poulomi Banerjee)
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