Dr Reddy’s announces Sputnik V meets primary endpoint of safety in Phase 2 trial in India
Dr Reddy’s submitted the phase 2 safety data for DCGI’s approval to continue phase 3 clinical trials
Dr Reddy’s Laboratories announced that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications.
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 DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety. Further, the safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval to continue phase 3 clinical trials.
G V Prasad, Co-chairman and MD, Dr Reddy’s Laboratories said, “The Indian clinical trial being conducted by Dr Reddy’s and 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. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India.”
Kirill Dmitriev, CEO of the 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 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.
In September 2020, Dr Reddy’s and Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of the Sputnik V vaccine and the rights for distribution in India.
The vaccine’s efficacy is confirmed at 91.4 per cent based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation.