Dr Reddys gets safe recommendation for third phase of Sputnik V clinical trial
Dr Reddy's Laboratories on Monday post-market hours informed that the independent Data & Safety Monitoring Board (DSMB) has reviewed the safety data from phase 2 clinical trial of Sputnik V vaccine and has given the approval to go ahead with phase 3 clinical trial after necessary prerequisites, without any modifications.
The company says that phase 2 of Sputnik V was conducted on 100 subjects as a part of the randomised, double-blind, parallel-group, placebo-controlled study in India. DSBM has confirmed that no safety concerns were identified and the study has met the primary endpoints of safety. The phase 2 of the clinical trial had shown a good safety profile in India. This further extends the company’s confidence in the safety of Sputnik V, which has been administered to more than 1 million people in Russia and more than 3,00,000 people in Argentina.
The company is working towards the accelerated launch of Sputnik V vaccine in India. The clinical trials would be conducted by JSS Medical Research as the clinical research partner in India. Dr Reddy's and Russian Direct Investment Fund (RDIF) had joined hands in September 2020 to conduct the clinical trials of Sputnik V vaccine and the rights for distribution in India. Sputnik V ranks among the top 10 candidate vaccines heading towards the end of clinical trials and the start of mass production on World Health Organisation’s (WHO) list.
Dr Reddy's Laboratories is a pharmaceutical company, which is engaged in providing medicines. It operates in 3 segments namely global generics, pharmaceutical services & active ingredients (PSAI), and proprietary products.
In spite of the news, the share of Dr Reddy's was trading down by 1.24 per cent at Rs 5,349.5 on Tuesday during the afternoon session.