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Aurobindo & MSN seek SEC's nod to discontinue molnupiravir phase III studies on moderate Covid-19 patients

Gireesh Babu, New Delhi
Saturday, October 9, 2021, 08:00 Hrs  [IST]

Two Indian pharma firms which are conducting clinical trials on US-drug major Merck & Co’s Covid-19 drug molnupiravir have requested permission from the expert panel of the drug regulator to discontinue late stage clinical trials on moderate Covid-19 patients and continue the trials in mild Covid patients.

In the 187th meeting of the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), held on October 4, 2021, to examine Covid-19 related proposals under the accelerated approval process, Hyderabad-based pharma firms Aurobindo Pharma and MSN Laboratories have submitted the request after presenting the interim clinical trial data in moderate Covid-19 patients.

The firms informed the SEC that they want to discontinue the phase III trial in moderate Covid-19 patients and continue the phase III trial in mild Covid patients.

In both the cases, the committee opined that the firm should submit the request in writing to CDSCO for further consideration. MSN has been conducting studies on molnupiravir 200 and 400 mg capsules, while Aurobindo has been conducting studies on molnupiravir 200 mg.

In the same meeting, Strides Pharma presented its proposal for some amendments before the committee for molnupiravir 200 and 400 mg capsules trials. The committee, after detailed deliberations, recommended for approval of proposed amendments in respect of RT-PCR negativity assessment at third day instead of 14th day and assessment of C Reactive Protein (CRP). The primary endpoint of the study will remain the same, it added.

Molnupiravir, an investigational oral antiviral medicine developed by Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics, has been identified as a drug which significantly reduce the risk of hospitalisation or death due to Covid-19, in patients with mild-to-moderate Covid viral infection.

At an interim analysis, the drug reduced the risk of hospitalisation or death by around 50 per cent. Around 7.3 per cent of patients who received molnupiravir were either hospitalised or died through Day 29, following randomisation, compared with 14.1 percent of placebo-treated patients, said Merck in the beginning of this month. Through day 29, no deaths were exported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo, it added.

Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorisation by local regulatory agencies. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022, it said.

In India, the company has entered into agreement with generic drug manufacturers including Cipla Ltd, Dr Reddy’s Laboratories, Sun Pharma, Aurobindo Pharma, Hetero Labs, Torrent Pharma, MSN Labs and Emcure Pharma. MSN Labs has initiated phase III clinical trials of the drug in the end of May, this year, with studies expected to be conducted on more than 2,400 subjects, in more than 40 sites across the country, according to reports.


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