Sputnik V meets the primary endpoint of safety in the Phase 2 Clinical Trial in India
January 11 2021 - 10:25AM
Business Wire
Dr. Reddy’s submitted the phase 2 safety
data for DCGI’s approval to continue phase 3 clinical
trials
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY) announced today 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 Managing Director, 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. 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 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.
Sputnik V developed by the Gamaleya National Research Institute
of Epidemiology and Microbiology was registered by the Ministry of
Health of Russia and became the world’s first registered vaccine
against COVID-19 based on the established human adenoviral vector
platform. It currently ranks among top 10 candidate vaccines
approaching the end of clinical trials and the start of mass
production on the World Health Organization’s (WHO) list. The
vaccine’s efficacy is confirmed at 91.4% 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.
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. ((BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Through its three
businesses - Pharmaceutical Services & Active Ingredients,
Global Generics and Proprietary Products – Dr. Reddy’s offers a
portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
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performance or events may differ materially from those in such
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conditions such as performance of financial markets, credit
defaults , currency exchange rates, interest rates, persistency
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competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
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including related integration issues, and (vi) the susceptibility of our industry
and the markets addressed by our, and our customers’, products and
services to economic downturns as a result of natural disasters,
epidemics, pandemics or other widespread illness, including
coronavirus (or COVID-19), and (vii) other risks and uncertainties
identified in our public filings with the Securities and Exchange
Commission, including those listed under the "Risk Factors" and
"Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2020. The company assumes no
obligation to update any information contained herein.”
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com (PH:
+91-40-49002135)
MEDIA RELATIONS APARNA TEKURI aparnatekuri@drreddys.com
(PH: +91-40- 49002446)
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