Two Indian drugmakers seek to end trials of Merck’s antiviral drug for moderate COVID-19

BENGALURU, Oct. 8 (Reuters) – Two Indian drugmakers have requested approval to end their late-stage trials of Merck & Co’s investigational antiviral drug molnupiravir (MRK.N) in patients with COVID-19 moderate.

The two Indian drug makers Aurobindo Pharma Ltd (ARBN.NS) and MSN Laboratories plan to continue research into the late stage of the drug for people with mild COVID-19, the Indian regulator’s expert committee said on Friday. medications.

The two companies have separately requested authorization to end trials in the case of moderate COVID-19 patients after submitting interim clinical trial data regarding the drug’s effectiveness in treating this category of patients, revealed the committee, questioning the effectiveness of the experiment. drug to improve outcomes for patients with moderate cases of COVID-19.

Separately, a senior source from India’s drug regulator told Reuters that molnupiravir had shown no “significant efficacy” against moderate cases of COVID-19. Read more

Merck’s shares soared last week after its partner Ridgeback Biotherapeutics said an interim analysis of a late-stage clinical trial of molnupiravir showed the drug nearly halved the risk of hospitalization or death for patients with mild or moderate COVID-19. Read more

It was not immediately clear whether Indian drugmakers and Merck were using identical criteria to define moderate cases of COVID-19.

Aurobindo Pharma, MSN and Merck did not immediately respond to Reuters requests for comment.

Merck has entered into voluntary licensing agreements with at least eight Indian drug makers for molnupiravir, with the aim of turning the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income countries. Read more

Aurobindo has been conducting a clinical trial of the drug in 100 patients with moderate COVID-19 since August of this year. According to the details of his trial, moderate patients included those with fever, cough, difficulty breathing and lack of oxygen.

Of the eight Indian companies, five – Dr Reddy’s Laboratories (REDY.NS), Cipla (CIPL.NS), Sun Pharma (SUN.NS), Torrent Pharmaceuticals (TORP.NS) and Emcure Pharmaceuticals – are conducting a joint trial for the drug. antiviral only in mild outpatient COVID-19 patients.

The other licensed company, Hetero, announced interim data from its own late-stage trial in the treatment of mild COVID-19 patients in early July and submitted an emergency use approval request for the same.

Hetero is separately conducting a study in moderate COVID-19 patients and said clinical results on the same topic will be shared in due course.

Reporting by Shivani Singh and Anuron Kumar Mitra in Bengaluru and Neha Arora in New Delhi; Editing by Rashmi Aich

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