Drug maker Hetero said on July 9 that the interim data of its Phase-3 study in India demonstrated that mild COVID-19 patients who had gotten COVID-19 antiviral drug Molnupiravir along with standard of care (SOC), recovered much faster than those who received standard of care.
Hetero had conducted phase-III, comparative, randomized, multicenter clinical trial on 1218 mild COVID-19 patients to evaluate 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 5 days of onset of symptoms.
The interim results show early clinical improvement observed in 63.43% of those in Molnupiravir group compared to standard of care at 22.33 percent on Day 5. For day 10 the improvement was seen at 78.96 percent vs 49.49 percent and Day 14 81.55 percent vs 73.22 percent. Median time to clinical improvement was seen as early as eight days in Molnupiravir group compared to 12 days in SOC alone group. ,
Earlier SARS CoV-2 RT-PCR negativity observed in Molnupiravir group compared standard of care at Day 5 was 77.35 percent vs 26.07 percent, Day 10 it was 94.03 percent vs 57.20 percent and Day 14 at 97.01 percent vs 85.21 percent.
There were fewer hospital admissions in Molnupiravir group compared to standard of care alone at 7 (1.89%) versus 23 (6.22%) over 14 days of observation.
The company said there was no mortality in either group.
Hetero said 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.
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.
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.
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 company said it will share interim and final clinical results in due course.
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).
Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It has shown activity against SARS-CoV-2 in human airway epithelial cell cultures and has potential to eliminate SARS CoV-2 from the body within 5 days.
It is presently being studied by MSD (Called as Merck in US), through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally.
Five India pharmaceutical companies such as Cipla, Dr Reddy's, Emcure, Sun Pharma and Torrent Pharma, who have similar licenses from MSD joined hands to conduct clinical trials of COVID-19 oral antiviral drug Molnupiravir.
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