‘Antisera’ phase 1 human trials get a green flag from DCGI as a potential Covid-19 treatment
Phase 1 human clinical trial for an antisera has been permitted by the Drugs Controller General of India (DCGI). The ‘antisera’ was developed by injecting inactivated SARS-CoV-2 virus in horses, and is believed to be a potential Covid-19 treatment, as relayed by ICMR officials. ICMR (Indian Council of Medical Research) has developed the antisera in association with Hyderabad based bio-pharmaceutical company.
ICMR Director General Dr. Balram Bhargava said during a press conference on Tuesday, “With Biological E Limited we have developed a horse ‘antisera’ and we have just got clearance for conducting clinical trials for that.”
Safety and efficacy is yet to be established through human clinical trials of the ‘antisera’. Antisera are blood serum which are high in antibodies against certain antigens. These are then injected in humans that help trigger immune system to fight the specific infections. ICMR had said in an earlier tweet “The ICMR and Biological E Limited, Hyderabad, have developed highly purified antisera (raised in animals) for prophylaxis and treatment of Covid-19.”
The details of study of the equine antisera development have been posted in a pre-print version on the Research Square platform. The study paper mentions “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 neutralization activity.”
“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 adds.
ICMR tweeted giving details “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. Standardization 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.”
The study involved 10 healthy horses who were immunized with inactivated SARS-C0V-2. 21 days post immunization plasma samples were tested that indicated presence of SARS-CoV-2 specific IgG antibodies. The detection was done using ELISA with neutralizing capacity.