Dr Reddy's said that it needed to engage 100 and 1,400 volunteers for Phase 2 and 3 trials respectively.
Dr Reddy’s Laboratories on Wednesday said the Phase 3 trials of Russia’s Sputnik V vaccine for COVID-19 in India to be conducted by it are expected to be completed by the end of March depending on approvals and data validation. The city-headquartered drug maker, which has received approval from the Drug Control General of India (DCGI) for conducting human clinical trials of Sputnik V, was expected to complete the Phase 2 trials by December, Dr Reddy’s Chief Executive Officer Erez Israeli said.
“Phase-3, we should finish somewhere by March and then of course it depends on the ability to compile the data, obtain the approvals etc. It can be as early as end of March or April /May and beyond. It depends on the results. Its a combination of phase-2, global phase-3 and phase-3 in India,” he told reporters here after announcing the company’s Q2 results. He said the company needed to engage 100 and 1,400 volunteers for Phase 2 and 3 trials respectively. Dr Reddy’s and Russian Direct Investment Fund (RDIF), Russias sovereign wealth fund, entered into a partnership last month to conduct clinical trials of Sputnik V and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the worlds first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Sputnik V is currently undergoing phase 3 clinical trials in Russia and the proposed number of subjects is 40,000.