DCGI nod to Phase-1 trials of potential COVID-19 treatment 'antisera'

The Drugs Controller General of India has given permission for conducting Phase-1 human clinical trial for an 'antisera' that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, Indian Council of Medical Research officials said on Tuesday.

The 'antisera' has been developed by the 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 said at press briefing on Tuesday.

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.

'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 pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform.

'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.

Earlier such measures were used for controlling several viral and bacterial infections.

'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.

As part of the study, 10 healthy horses were immunised with inactivated SARS-CoV-2 and after 21 days of immunisation, plasma samples were tested.

The results of the plasma samples indicated presence of SARS-CoV-2 specific IgG antibodies as detected in ELISA with neutralising capacity.