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DCGI okays phase-1 human trials of ‘antisera’ with potential to treat COVID-19

DCGI okays

The DGCI (Drugs Controller General of India), the apex healthcare research body has given approval for conducting Phase-1 human clinical trial for an “antisera” which has potential to treat COVID-19, ICMR officials said. ‘Antisera’ which was developed by injecting inactivated SARS-CoV-2 in horses.

The ‘antisera’ has been jointly developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm. “With Biological E Limited we have developed an horse ‘antisera’ and we have just got clearance for conducting clinical trials for that,” ICMR Director General Dr Balram Bhargava was quoted saying by a PTI report.

The ‘antisera’ is yet to undergo human clinical trials to establish safety and efficacy. Antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections.

Also read: Zenara Pharma gets DCGI approval to manufacture and sell Favipiravir tablets

“The ICMR and Biological E Limited, Hyderabad, have developed highly purified antisera (raised in animals) for prophylaxis and treatment of COVID-19,” the apex health research body had earlier said in a tweet.

“The study provides evidence of the potential of generating highly purified F(ab’)2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralisation activity,” the study paper said.

“Further, in-vivo testing for efficacy of this indigenously developed, cost effective product will pave the way to clinical evaluation. Additionally, being a donor independent method, this may prove as an efficient alternative to convalescent plasma for treatment of COVID-19 patients,” it said.

“Although, plasma recovered from patients experiencing COVID-19 could serve similar purpose, the profile of antibodies, their efficacy and concentration keep varying from one patient to another and therefore, make it an unreliable clinical tool for patient management,” the ICMR had said in a tweet. “Standardisation achievable through equine sera based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of COVID-19,” it said.

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