- Data from 25,800 phase 3 study participants in India, who received vaccine or placebo at a ratio of 1: 1, showed that the candidate vaccination was well tolerated and that 81% was effective in preventing COVID-19 in people with no prior infection after the second dose.
- Clinical study to proceed to the final analysis of 130 confirmed cases to collect further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints.
MALVERN, Pa., March 3, 2021 (GLOBE NEWSWIRE) – Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on the discovery, development and commercialization of gene therapies to cure blindness diseases and to develop a vaccine to save lives from COVID-19 today announced that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a completely virion-inactivated COVID-19 vaccine candidate. COVAXIN showed a vaccine effectiveness of 81%.
“We are very pleased with the interim results of COVAXIN’s Bharat Biotech Phase 3 study in India. These results, which indicate in part significant immunogenicity against the rapidly emerging UK variant, represent an additional step towards outlining the regulatory pathway for EUA and approval in the United States. COVAXIN, a fully virion-based vaccine candidate, is designed to address a significant unmet need in our national arsenal of COVID-19 vaccines, ”said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-founder of Ocugen. .
Today’s results of the interim analysis of Bharat Biotech’s Phase 3 study of COVAXIN mark a milestone in the development of another critical vaccine option for the US market. COVAXIN has been shown to induce immune responses against multiple protein antigens of the virus, potentially reducing the possibility of mutant virus escape. This breadth of immune responses has been demonstrated by the ability of antibodies induced by COVAXIN to neutralize the British variant of SARS-Cov-2, ”said Dr. Bruce Forrest, member of Ocugen’s Scientific Advisory Board on Vaccines.
Phase 3 interim results as reported by Bharat Biotech
The Phase 3 clinical trial of Bharat Biotech enrolled 25,800 participants aged 18-91, including 2,433 over the age of 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 first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%.
The interim analysis included a preliminary assessment of the safety database, which showed that serious, serious and medically-attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The conduct and monitoring of the study are in accordance with good clinical practice guidelines and are outsourced to IQVIA.
Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the British variant strains and other heterologous strains, as published in bioRxiv.
Bharat Biotech expects to share further details of the study results as additional data becomes available. An additional interim analysis is planned for 87 cases and the final analysis is planned for 130 cases. All data from the second interim and final analysis is shared through pre-publish servers and submitted to a peer-reviewed journal for publication.
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 is 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 several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8TheC.
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 diseases with one drug – ‘one in many’ and our new biologic product candidate aims to provide better therapy to patients with disadvantaged diseases such as wet age-related macular degeneration, diabetic macula. edema and diabetic retinopathy. We are jointly developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the US market. For more information, please visit www.ocugen.com.
About Bharat Biotech:
Bharat Biotech has built an excellent 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 pre-qualifications from the World Health Organization (WHO). 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 tetanus toxoid conjugated vaccine for typhoid fever.
Bharat’s commitment to global social innovation programs and public-private partnerships resulted in the introduction of groundbreaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® that fight polio, rotavirus and typhoid infections respectively. The recent acquisition of the anti-rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. For more information about Bharat Biotech, please 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 such as ‘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 authorities; 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 drug and / or emergency license applications can be filed for COVAXIN; if and when such applications can be approved by the FDA; decisions of the FDA that affect the 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
Chief Financial Officer and Head of Corporate Development
[email protected]
Media contact:
For Ocugen:
LaVoieHealthScience
Emmie Twombly
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+1 857-389-6042
Lisa DeScenza
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