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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 humans without prior infection
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Shows 70% efficacy against asymptomatic COVID-19 infections; indicates potential to significantly reduce virus transmission
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COVAXIN has been administered to millions of people in India and is playing a vital role in fighting 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 develop 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 completely virion-inactivated COVID-19 vaccine candidate. COVAXIN showed vaccine efficacy in mild, moderate and severe COVID-19 disease of 78% with efficacy against only severe COVID-19 disease of 100%.
“We remain enthusiastic about the compelling second interim results of Bharat Biotech’s Phase 3 clinical trial. We believe that COVAXIN could help change the course of this pandemic by preventing serious COVID-19 disease, including hospital admissions, by 100% and significantly reducing the spread of asymptomatic COVID-19 infections based on the evidence to date. proven efficacy. We are committed to being part of the solution to save lives of COVID-19 by bringing COVAXIN to the US market. Based on a traditional vaccine platform with a well-established safety profile, we believe COVAXIN is an important tool to add to our national arsenal in ending the pandemic, ”said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen.
“The safety and efficacy demonstrated by COVAXIN is remarkable due to the prevalence of several variants of the coronavirus that were circulating at the time of 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, member of Ocugen’s scientific advisory board on vaccines.
Results of the second interim phase 3 as reported by Bharat Biotech
The Phase 3 clinical study of Bharat Biotech enrolled 25,800 participants aged 18-91 in India, including 2,433 over 60 and 4,500 with co-morbidities. The primary endpoint of the Phase 3 clinical trial 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 serologically negative (against SARS-CoV – 2) adult participants at the start.
The second interim analysis is based on the collection of more than 87 symptomatic cases of COVID-19. However, due to the recent increase in the number of cases in India, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95% CI: 61-88) against mild, moderate and severe COVID-19. disease. The trial will continue until its scheduled completion.
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, India’s COVID-19 vaccine by Bharat Biotech, has been developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine manufactured using a vero cell production platform with an outstanding safety record of over 300 million doses delivered.
In addition to generating a strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, due to its multiple epitopes, indicating a long lifespan and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to the data available 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 the discovery, development and commercialization of gene therapies to cure blindness diseases and develop a vaccine to save lives from COVID-19. Our breakthrough modifying gene therapy platform has the potential to treat multiple retinal disorders with one drug – ‘one in many’ and our new biologic product candidate aims to provide better therapy for patients with disadvantaged diseases such as wet age-related macular degenerative edema and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN ™ vaccine for COVID-19 in the US market. For more information, please visit www.ocugen.com.
About Bharat Biotech
Bharat Biotech has an outstanding track record of innovation with more than 145 worldwide patents, a broad product portfolio of more than 16 vaccines, 4 biotherapeutics, registrations in more than 123 countries and the World Health Organization (WHO) Pre-qualifications. Based in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has developed world-class vaccine and biotherapeutics, research and product development, biosafety level 3 manufacturing, and vaccine delivery and distribution.
Bharat Biotech has delivered more than 4 billion doses of vaccines worldwide and remains innovative, developing vaccines for influenza H1N1, Rotavirus, Japanese encephalitis, rabies, Chikungunya, Zika and the world’s first conjugated tetanus toxoid vaccine for typhoid fever. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in the introduction of breakthrough WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® that fight polio, rotavirus and typhoid infections respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. For more information about Bharat Biotech, visit www.bharatbiotech.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We can use terms like ‘predicts’, ‘believes’, ‘potential’, ‘proposed’, ‘continue’, ‘estimate’, ‘anticipates’, ‘expects’, ‘plans’, ‘intends’, in some cases “May”, “could”, “could”, “will”, “would” or other words expressing uncertainty about future events or results to identify these forward-looking statements. Such forward-looking statements contain information about qualitative assessments of available data, potential benefits, expectations for clinical trials and expected timing of clinical trial readings and regulatory submissions This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Risks and uncertainties include, among others, the uncertainties inherent in research and development, including the ability to n to meet expected clinical endpoints, clinical trial start and / or completion dates, regulatory submission dates, regulatory approval dates and / or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data subject to this release), including the possibility of unfavorable new clinical trial data and further analysis of existing clinical trial data; the risk that clinical trial data will be subject to differing interpretations and judgments, including during the peer review / publication process, in the scientific community at large and by regulatory agencies; if and when data from Bharat Biotech’s clinical studies will be published in scientific journals and, if so, when and with what changes; 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; if and when in the United States a biologic authorization and / or emergency authorization applications can be filed for COVAXIN; if and when such applications can be approved by the FDA; decisions by the FDA that affect labeling, manufacturing processes, safety, and / or other matters that could 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 filings with the Securities and Exchange Commission (SEC), including the risk factors described in the “Risk Factors” section of the quarterly and annual reports we file with the SEC. Any forward-looking statements we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update any forward-looking statements in this press release, whether as a result of new information, future events or otherwise, after the date of this press release.
Ocugen contact person:
Ocugen, Inc.
Sanjay subramanian
CFO and Head of Corp. The V.
[email protected]
Media contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
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