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The primary efficacy in the second intermediate analysis demonstrates that COVAXIN is 78% effective after the second dose in preventing COVID-19 in those without a previous infection.
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Demonstrates 70% efficacy against asymptomatic COVID-19 infections; indicates the potential to significantly reduce 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 the discovery, development and commercialization of gene therapies to cure blindness and develop a vaccine to save the lives of COVID-19, announced today that its co-development partner, Bharat Biotech, shared the positive results of the second interim analysis of his phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a mild, moderate, and severe COVID-19 vaccine efficacy of 78%, with only 100% efficacy against severe COVID-19 disease.
“We continue to be excited about the compelling interim results of the second phase 3 clinical trial in Bharat Biotech. We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease, including 100% hospitalizations, and by significantly limiting the spread of asymptomatic COVID-19 infections based on the efficacy shown so far. We are dedicated to being part of the life-saving solution of COVID-19 by bringing COVAXIN to the US market. Based on a traditional vaccine platform that has a long-established safety profile, we believe that COVAXIN is an important tool to add to our national arsenal to end the pandemic, ”said Dr. Shankar Musunuri, Chairman of the Board, Director executive and Co-Founder of Ocugen.
The safety and efficacy of COVAXIN are remarkable due to the prevalence of several variants of the coronavirus circulating at the time of the study. This vaccine is based on a proven technology platform and the company intends to consider clinical development in special populations, such as children, ”said Dr. Bruce Forrest, a member of the Ocugen Vaccine Scientific Advisory Board.
The second intermediate phase 3 result, reported by Bharat Biotech
The Bharat Biotech Phase 3 clinical trial enrolled 25,800 participants aged 18 to 91 in India, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the phase 3 clinical trial is based on the first onset of symptomatic PCR (mild, moderate, or severe) confirmed COVID-19 with onset at least 14 days after the second negative serological vaccination study (SARS). -CoV -2) adult participants at baseline.
The second intermediate analysis is based on the accumulation of over 87 symptomatic cases of COVID-19. However, due to the recent increase in cases in India, 127 symptomatic cases were reported, resulting in a timely estimate of vaccine efficacy of 78% (95% CI: 61-88) against mild, moderate and severe COVID-19 disease. The process will continue until the pre-planned 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, the India COVID-19 vaccine by Bharat Biotech, is being developed in collaboration with the Indian Medical Research Council (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine, which is manufactured using a vero cell manufacturing platform with an excellent safety experience of over 300 million doses provided.
In addition to generating a strong immune response against several antigens, COVAXIN has been shown to generate memory T cell responses for multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a higher safety profile than data available for several other vaccines, COVAXIN is packaged in multiple 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 for the cure of blindness and the development of a vaccine to save the lives of COVID-19. Our discovery-modifying gene therapy platform has the potential to treat multiple retinal diseases with a single drug – “one in many,” and our new biologic candidate aims to provide better therapy for patients with underlying diseases, such as be macular degeneration related to wet age, macular diabetes edema and diabetic retinopathy. We are co-developing the COVAXIN ™ vaccine of Bharat Biotech candidate for COVID-19 on the US market. For more information, please visit www.ocugen.com.
About Bharat Biotech
Bharat Biotech has established an excellent innovation experience with more than 145 patents worldwide, a wide product portfolio of over 16 vaccines, 4 bio-therapeutic products, registrations in over 123 countries and World Health Organization pre-qualifications ( WHO). Located in the Genome Valley of Hyderabad, India, a hub for the global biotechnology industry, Bharat Biotech has built a world-class and bio-therapeutic vaccine, product research and development, bio-level 3 manufacturing and vaccine supply and distribution.
After delivering over 4 billion doses of vaccines worldwide, Bharat Biotech continues to drive innovation and has developed vaccines for H1N1 flu, Rotavirus, Japanese encephalitis, rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugate vaccine for typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships has led to the introduction of pre-competent WHO BIOPOLIO®, ROTAVAC® and Typbar TCV® vaccines, which fight polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine factory, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest producer of rabies vaccine in the world. To learn more about Bharat Biotech, visit www.bharatbiotech.com.
Warning note on 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 may, in some cases, use terms such as “predict,” “believe,” “potential,” “proposed,” “continue,” “estimate,” “anticipate,” “expect,” “plan,” “intend,” “Maybe”, “could”, “could”, “will”, “should” or other words that convey uncertainty about future events or results to identify these forward-looking statements. Such forward-looking statements include information on qualitative assessments of available data, potential benefits, expectations for clinical trials and the anticipated timing of clinical trial readings and regulatory presentations. This information implies risks and uncertainties that could cause the actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, including the ability to meet anticipated clinical objectives, start and / or end dates of clinical trials, regulatory submission data, regulatory approval data and / or launch, as well as the risks associated with preliminary and interim data (including phase 3 interim data covered by this Communication), including the possibility of new unfavorable clinical trial data and further analysis of existing clinical trial data; the risk of clinical trial data being subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community at large and by regulators; if and when data from Bharat Biotech clinical trials will be published in scientific journals and, if so, when and with what changes; whether the US Food and Drug Administration (FDA) will be pleased with the design and results of preclinical and clinical studies of COVAXIN, which were conducted by Bharat Biotech in India; if and when any biological license and / or applications for emergency use authorization may be filed in the United States for COVAXIN; if and when such applications may be approved by the FDA; FDA decisions affecting labeling, manufacturing processes, safety, and / or other issues that could affect the availability or commercial potential of COVAXIN in the United States, including product development or therapies by other companies. These and other risks and uncertainties are described in more detail in our regular submissions to the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in our quarterly and annual reports to the SEC. Any forward-looking statements we make in this press release speak only as of the date of this press release. Except as provided by law, we assume no obligation to update the advance statements contained in this press release, whether as a result of new information, future events or otherwise, after the date of this press release.
Contact Ocugen:
Ocugen, Inc.
Sanjay subramanian
Chief Financial Officer and Chief of Staff Dev.
[email protected]
Media contact:
LaVoieHealthScience
Lisa DeScenza
[email protected]
+1 9783955970