Zydus has started dosing participants in the Phase I/II clinical trials of its Covid-19 vaccine candidate, ZyCoV-D, following the Drug Controller General of India (DCGI) approval earlier this month.
In preclinical studies, the vaccine candidate was able to induce a ‘strong immune response’ in different animal species, including mice, rats, guinea pigs, and rabbits.
The antibodies generated were observed to neutralise the wild type virus when tested in virus neutralisation assay. This is said to indicate the protective potential of the product.
In repeat dose toxicology studies, no safety concerns were reported for the vaccine candidate administrated via intramuscular and intradermal routes.
According to the company, up to three times the intended human dose was observed to be safe, well tolerated and immunogenic in rabbits.
The adaptive, dose escalation, multi-centric Phase I/II trial will evaluate the safety, tolerability and immunogenicity of ZyCoV-D in more than 1,000 volunteers. It will be performed at several sites across the country.
Zydus Cadila chairman Pankaj Patel said: “We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India and regulatory agencies ICMR and DCGI in the development of ZyCoV-D vaccine candidate.
“We look forward to the adaptive Phase I/II clinical studies and gathering important data on ZyCoV-D in the months ahead.”
The company has already produced clinical batches of ZyCoV-D for the human trials. Zydus developed the Covid-19 vaccine candidate at its Vaccine Technology Centre in Ahmedabad, India.
Earlier this month, Zydus received approval from the Mexican regulatory authority, COFEPRIS, to assess Desidustat as a potential Covid-19 treatment.
Zydus will conduct a multi-centre, open-label, randomised, comparator-controlled Phase IIb trial to assess the safety and efficacy of the desidustat tablet for managing the disease.