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Primary efficacy in the second interim analysis shows that COVAXIN is 78% effective after the second dose to prevent COVID-19 in those without prior infection
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Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates the possibility of significantly reducing virus transmission
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COVAXIN has been administered to several million people in India and plays a critical role in combating the pandemic
MALVERN, Pa., April 21, 2021 (GLOBE NEWSWIRE) – Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, announced today that its co-development partner , Bharat Biotech, shared positive results from the second interim analysis of its Phase 3 study of COVAXIN, a whole virion-inactivated COVID-19 vaccine candidate. COVAXIN has shown vaccine efficacy in mild, moderate and severe COVID-19 disease of 78%, with efficacy in severe COVID-19 disease alone of 100%.
“We are still excited about the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN can help change the course of this pandemic by 100% preventing serious COVID-19 disease, including hospitalizations, and significantly reducing the spread of asymptomatic COVID-19 infections due to its efficacy up to so far shown. We would like to be part of the solution to save the lives of COVID-19 by bringing COVAXIN to the US market. “Based on a traditional vaccine platform with a long-established safety profile, we believe COVAXIN is an important tool in contributing our national arsenal to ending the pandemic,” said Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-Founder of Ocugen.
The safety and efficacy shown by COVAXIN are remarkable due to the presence of several variants of the coronavirus circulating during the trial. This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children, ‘said Dr. Bruce Forrest, a member of Ocugen’s advisory board, said.
Second Interim Phase 3 Results as Reported by Bharat Biotech
Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between the ages of 18-91 in India, including 2,433 older than 60 and 4,500 with disease conditions. The primary endpoint of the clinical phase 3 study is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 starting at least 14 days after the second study vaccination in serological negative (versus SARS-CoV -2) adult participants at the starting line.
The second interim analysis is based on the build-up of more than 87 symptomatic cases of COVID-19. However, due to the recent increase in cases in India, 127 symptomatic cases were recorded, resulting in a score estimate of the vaccine efficacy of 78% (95% CI: 61-88) against mild, moderate and severe COVID-19 disease had. The trial will continue until its pre-scheduled closing.
The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.
About COVAXIN
COVAXIN, the COVID-19 vaccine from India by Bharat Biotech, was developed in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine manufactured using a vero-sel manufacturing platform with an excellent safety record of over 300 million doses supplied.
In addition to eliciting strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses for its multiple epitopes, indicating a long lifespan and a rapid antibody response to future infections. With published data showing a safety profile that is better than the available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8⁰C.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing gene therapies to cure blindness diseases and develop a vaccine to save the lives of COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many”, and our new candidate for biological products is aimed at better treatment of patients with subarachnoid diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are developing with Bharat Biotech’s COVAXIN stof vaccine candidate for COVID-19 in the US market. Visit www.ocugen.com for more information.
About Bharat Biotech
Bharat Biotech has set an excellent record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutic agents, registrations in more than 123 countries, and the World Health Organization (WHO) qualifications. Bharat Biotech, located in Genome Valley in Hyderabad, India, a hub for the global biotechnology industry, has built a world-class vaccine and biotherapeutic agent, research and product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.
After delivering more than 4 billion doses of vaccines worldwide, Bharat Biotech has continued to develop vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus toxoid conjugated vaccine for typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships has led to the launch of groundbreaking WHO-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® that fight polio, rotavirus and typhoid infections, respectively. Bharat Biotech has positioned the acquisition of the rabies vaccine Chiron Behring from GlaxoSmithKline (GSK) as the world’s largest rabies vaccine manufacturer. Visit www.bharatbiotech.com for more information on Bharat Biotech.
Warning about forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Security Reform Litigation Act of 1995, which is subject to risks and uncertainties. In some cases, we may use terms such as ‘predict’, ‘believe’, ‘potential’, ‘proposed’, ‘continue’, ‘estimate’, ‘expect’, ‘expect’, ‘plan’, ‘intend,’ “Power,” “could,” “power,” “will,” “must” or other words that are uncertain about future events or outcomes to identify these forward-looking statements.Such forward-looking statements contain information about qualitative assessment of available data, potential benefits, expectations for clinical trials and the expected timing of clinical trials and regulatory submissions.This information involves risks and uncertainties that could lead to actual results that differ materially from those expressed or implied by such statements. the uncertainties inherent in research and development, including the ability to meet expected clinical endpoints, start and / or completion dates for clinical trials, dates for submission of r regulations, approval dates and / or release dates of regulations, as well as risks associated with preliminary and interim data (including the phase 3 interim data that is the subject of this version), including the possibility of adverse new clinical trial data and further analyzes of existing clinical data. test data; the risk that clinical trial data are subject to different interpretations and assessments, including during the peer review / publication process, in the scientific community in general and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what amendments; whether the US Food and Drug Administration (FDA) will be satisfied with the design and results of preclinical and clinical studies of COVAXIN, conducted by Bharat Biotech in India; whether and when any biological license and / or emergency permit applications may be filed in the United States for COVAXIN; whether and when such applications can be approved by the FDA; FDA decisions that affect the labeling, manufacturing processes, safety and / or other issues that may affect the availability or commercial potential of COVAXIN in the United States, including the development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filing with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports we submit to the SEC. Any forward-looking statements we make in this press release apply only to the date of this press release. Except as required by law, we accept no obligation to update forward-looking statements in this press release, whether due to new information, future events or otherwise, after the date of this press release.
Ocugen contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corp. Dev.
[email protected]
Media contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970