Pharma

Dr. Reddy’s seeks approval to continue Phase 3 trial

The Phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.

  • By ICN Group | January 13, 2021

Dr. Reddy’s Laboratories Ltd. has reviewed the safety data from the Phase 2 clinical trial of the Sputnik V vaccine and submitted the data to Drugs Controller General of India (DCGI) for approval and to continue Phase 3 trial.   

The Phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. The safety data has been reviewed and submitted to the Drugs Controller General of India (DCGI) for review and approval to continue Phase 3 clinical trial.

G. V. Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “The Indian clinical trial being conducted by Dr. Reddy’s and Russian Direct Investment Fund (RDIF) is an adaptive design Phase 2/3 trial. It is a bridging study to the larger global phase 3 study on 31,000 subjects. The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India.”

Kirill Dmitriev, CEO, Russian Direct Investment Fund said, “The safety data from the phase 2 clinical trial from India is very positive and confirms the safety profile of Sputnik V in the international markets. The Sputnik V consistently shows safety and high efficacy in international clinical trials as it is based on a safe human adenoviral vector platform.”

The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterisation and to use BIRAC’s clinical trial centres for the vaccine.

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