Two drugmakers in the country have requested permission to end their late-stage trials on Merck & Co.’s experimental antiviral drug molnupiravir in moderate COVID-19 patients.
The drug regulator’s expert committee on Friday said two drugmakers, Aurobindo Pharma Ltd and MSN Laboratories, plan to continue the late-stage trails of the drug for people with mild COVID-19.
After submitting interim clinical trial data about the drug’s effectiveness in treating this category of patients, both the companies sought permission to terminate the trial in case of moderate COVID-19 patients, the committee disclosed, experimental questioned its efficacy. Outcome-improving drug for patients with moderate cases of COVID-19.
Separately, a source at the drug regulator told Reuters that molnupiravir had shown no “significant efficacy” against moderate COVID-19 cases.
Shares in Merck soared last week after partner Ridgeback Biotherapeutics said an interim analysis of a late-stage clinical trial on mollupiravir showed the drug worked well for mild or moderate COVID-19. Nearly halved the risk of hospitalization or death for patients.
It was not immediately clear whether the drugmaker and Merck used the same criteria to define moderate COVID-19 cases.
Aurobindo Pharma, MSN and Merck did not immediately respond to Reuters requests for comment.
Merck has entered into voluntary licensing agreements for Molnupiravir with at least eight Indian drug manufacturers, with the aim of turning the country into a manufacturing hub for the drug to supply low- and middle-income countries.
Aurobindo Pharma is conducting clinical trials on the drug in 100 patients with moderate COVID-19 from August this year
According to its testing details, the moderate patients included those with fever, cough, difficulty in breathing and lack of oxygen.
Of the eight Indian firms, five – Dr Reddy’s Laboratories, Cipla, Sun Pharma, Torrent Pharmaceuticals and Emcure Pharmaceuticals – are conducting a combined trial for an antiviral drug in only mild COVID-19 patients in an outpatient setting.
The other licensed company, Hetero, in early July announced interim data from its own late-stage trial in treating mild COVID-19 patients and submitted an application for emergency use approval for the same.
Hetero is separately conducting a study on moderate COVID-19 patients and has said that the clinical results on the same will be shared in due course.