Cadila Health seeks nod to start phase III clinical trials of ZyCoV-D

The drug maker announced on Thursday (24 December 2020) that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials.

The company is now planning to initiate Phase III clinical trial in around 30,000 volunteers upon receiving necessary approvals.

The Phase II study of the vaccine ZyCoV-D had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo controlled study.

The vaccine was found to be safe and immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome.

Speaking on the development, Mr. Pankaj R. Patel, chairman of the Zydus Group said, After establishing safety in Phase I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the Novel Vaccine on its successful completion.

Cadila Healthcare is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

The company's consolidated net profit soared 411% to Rs 423.60 crore on 16% jump in net sales to Rs 3,762.30 crore in Q2 September 2020 over Q2 September 2019.

The scrip was up 0.29% at Rs 491.05. It traded in the range of 488.90 and 499 so far during the day.

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