iSERA Biological begins COVID drug human trials

Mumbai: A company in western Maharashtra has started human trials of a drug targeted at mild and moderately infected coronavirus patients, a top official said.

The company is hopeful of launching the product by the year-end after completing all the phases of trials, the official said.

World's largest vaccine maker Serum Institute of India (SII) is the sponsor of the Pune-headquartered iSERA Biological Pvt Ltd's drug project, which began soon after COVID-19 hit Indian shores.

The company's primary activity is the manufacturing of antiserum products for snakebites and rabies, and it is using the same process for development of the anti-Covid drug as well, its director Pratap Deshmukh told PTI.

He did not disclose the investment by his company and SII in the drug development. There has been no reaction from the Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, on the drug project.

"The drug project started as an idea to check if we can use Covid anti-bodies to help a patient. It was followed up with pre-clinical studies, analyzing neutralizing values and animal studies," he said.

The results so far have been encouraging, he said, adding the company will be able to deliver the drug at a tenth of the cost charged by the alternative produced by pharma major Roche.

Deshmukh said his company got the test license from the Drugs Controller General of India in April 2020 and SII came on board in June the same year, helping with the supply of antigens, he said.

These antigens are given to horses, who develop antibodies, using which the drug is manufactured after a purification process, he added.

This is a tested process used for over a century in making anti-venoms, Deshmukh said.

The 'polyclonal cocktail' being developed by iSERA will be safer than Roche's monoclonal cocktail, he claimed.

While SII will be holding the intellectual property being the sponsor, iSERA will be a partner, Deshmukh said.

The safety of the drug is being established during the human trials, after which the company will begin the second and third phase to establish its efficacy and define the dosage to ultimately seek an emergency use authorisation, he said.

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