Five Indian pharmaceutical companies have partnered to conduct a clinical trial of Merck (MSD)’s experimental antiviral candidate molnupiravir to treat mild Covid-19 in an outpatient setting.
The partners are Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries and Torrent Pharmaceuticals.
These companies separately signed non-exclusive voluntary licensing agreements with Merck between March and April this year to manufacture and supply the drug to India and more than 100 low and middle-income countries.
Molnupiravir is an oral drug designed to block the replication of various RNA viruses, including the SARS-CoV-2 virus.
Under the latest agreement, the partners will together sponsor, oversee and track the trial of the drug candidate in India.
Dr Reddy’s will perform the trial using its product, according to a directive issued by the Central Drugs Standard Control Organization’s Subject Expert Committee.
The remaining four companies must establish the equivalence of their product to Dr Reddy’s product.
Set to be carried out between this month and September 2021, the trial will follow the protocol approved by the Drugs Controller General of India. It will enrol 1,200 patients with mild Covid-19 across India.
If the study yields positive data, each of the five companies will individually seek regulatory approvals to produce and distribute molnupiravir for Covid-19 in the country.
Merck and its partner Ridgeback Biotherapeutics are currently assessing the drug in a global Phase III trial to treat non-hospitalised Covid-19 patients.
Earlier this year, Merck and Ridgeback reported preliminary data from a Phase IIa Covid-19 trial of molnupiravir in the US.
Data showed a decrease in time to negativity of infectious virus isolation in nasopharyngeal swabs from patients with symptomatic Covid-19.
In another development, Cipla has obtained regulatory approval to distribute Moderna’s Covid-19 vaccine in India, reported Reuters citing a senior government official.
While a definitive deal for commercial supply is yet to be signed, Cipla is aiding Moderna in the regulatory approval and the import of vaccines to be donated to the country.