Cadila gains 5% on DGCI nod for clinical trials of Covid-19 vaccine

Shares of Cadila Healthcare surged 5 per cent to Rs 380 on the BSE on Friday after the company said its vaccine candidate for Covid-19 (ZyCoV-D) has received the permission from DGCI for human clinical trials.

In an exchange filing, the company said it has received the approval from Drug Controller General of India - Central Drugs Standard Control Organisation (DCGI-CDSCO) to initiate Phase I/II human clinical trials for its Covid-19 (plasmid DNA) vaccine. The company has completed preclinical development and plans to begin the trials in July 2020, it said.

In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs, and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay, indicating the protective potential of the vaccine candidate, Cadila Healthcare said.

No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic, it said.

The company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

At 09:20 am, Cadila Healthcare had erased its early morning surge and was trading 1.7 per cent higher at Rs 369.55 on the BSE, as compared to 0.35 per cent rise in the S&P BSE Sensex. The stock was trading close to its 52-week high of Rs 383.65, touched on June 15, 2020. A combined 1.98 million equity shares have changed hands on the counter on the NSE and BSE, so far.