Zydus Cadila announces completion of dosing in Phase I Clinical Trial of ZyCoV-D

Zydus Cadila, an innovation driven global pharmaceutical company focused on discovering and developing NCEs, Novel Biologicals, Biosimilars and Vaccines, today announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe and well tolerated in the Phase I clinical trial. The company will now commence Phase II clinical trials from the 6th of August, 2020.

The Company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on 15th July 2020, has been well tolerated. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.

"The Phase I dosing to establish the safety of ZyCoV-D is an important milestone," said Mr. Pankaj R. Patel, Chairman Zydus Cadila. "All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population."

The 7 day safety of the vaccine in all the subjects enrolled in the Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial. The Phase I study of ZyCoV-D will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose escalation, multicentric, randomized, double-blind placebo controlled study. The phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate in line with the current global clinical trial protocols in general. The neutralization potential of the antibodies elicited by the vaccine would also be checked by virus neutralization assay. The durability of the humoral response up to 6 months post last dose will also be evaluated.

With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

The plasmid DNA when introduced into the host cells would be translated into the viral protein and will elicit a strong immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance. Zydus acknowledges the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India in the development of ZyCoV-D.

Shares of CADILA HEALTHCARE LTD. was last trading in BSE at Rs.402.85 as compared to the previous close of Rs. 395.15. The total number of shares traded during the day was 461510 in over 8989 trades.

The stock hit an intraday high of Rs. 405.4 and intraday low of 390.6. The net turnover during the day was Rs. 183938841.

Source : Equity Bulls

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