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Aurobindo, MSN to halt Phase 3 trial in moderate Covid patients

G Naga Sridhar Hyderabad | Updated on October 08, 2021

Submit interim clinical trial data to the Subject Expert Committee

Aurobindo Pharma and MSN Laboratories plan to discontinue the Phase 3 trials of molnupiravir, an antiviral oral drug of Merck & Co, used in patients with moderate Covid.

Both firms have submitted the interim clinical trial data to the Subject Expert Committee (SEC) at its meeting held on Friday.

According to the minutes of the SEC meeting, MSN and Aurobindo submitted separate presentations to the SEC that they would like to discontinue the Phase 3 trials of molnupiravir in patients with moderate Covid and continue Phase 3 trials in patients with mild Covid.

The SEC opined that the firms should submit their respective applications expressing their desire to discontinue Phase 3 trials of molnupiravir in patients with moderate Covid to the Central Drug Standard Control Organisation.

Licensing pact

Merck had entered into a voluntary licensing pact with Aurobindo Pharma for the oral drug molnupiravir earlier this year. It commenced the trial in August.

Molnupiravir is also being studied in a Phase 3 trial for the treatment of non-hospitalised Covid patients. In April, MSD Pharmaceuticals had entered into non-exclusive voluntary licensing agreements on molnupiravir with five Indian generic manufacturers – Cipla, Dr Reddy’s Laboratories Limited, Emcure Pharmaceuticals, Hetero Labs and Sun Pharma.

Another Hyderabad-based company, Hetero, had recently declared interim data from a late-stage trial in mild Covid patients and submitted an application for drug control emergency-use approval for the same.

Published on October 08, 2021

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