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Data from 25,800 participants in the Phase 3 trial in India, who received a 1: 1 vaccine or placebo, showed that the candidate vaccine was well tolerated and demonstrated an 81% effectiveness in preventing COVID-19 in those without prior infection after second dose.
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The clinical trial will continue until the final analysis in 130 confirmed cases, in order to collect more data and assess the effectiveness of COVAXIN in additional secondary study outcomes.
MALVERN, Pa., March 3, 2021 (GLOBE NEWSWIRE) – Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on the discovery, development and commercialization of genetic therapies to cure blindness diseases and develop a vaccine to save COVID-19 lives, today announced that its co-development partner, Bharat Biotech, has announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a COVID-19 candidate vaccine inactivated by entire virion. COVAXIN demonstrated a vaccine effectiveness of 81%.
“We are excited about the interim efficacy results of the Bharat Biotech phase 3 study with COVAXIN in India. These results, which in part suggest significant immunogenicity against the rapidly emerging UK variant, represent an additional step in outlining the regulatory path for the United States and approval in the United States. COVAXIN, a complete virion-based candidate vaccine, is designed to fill a significant unmet need in our national COVID-19 vaccine arsenal, “said Dr. Shankar Musunuri, chairman, chief executive officer and co-founder of Ocugen.
“Today’s results from the interim analysis of Bharat Biotech’s Phase 3 trial with COVAXIN are a milestone in the development of another critical vaccine option for the US market. COVAXIN has been shown to induce immune responses against various protein antigens in the virus, potentially reducing the chance of escape from the mutant virus. This breadth of immune responses was demonstrated by the ability of COVAXIN-induced antibodies to neutralize the UK variant of SARS-Cov-2, ”said Dr. Bruce Forrest, member of Ocugen’s vaccine scientific advisory board.
Interim results from phase 3, as reported by Bharat Biotech
The Bharat Biotech Phase 3 clinical trial involved 25,800 participants between 18-91 years of age, including 2,433 over 60 and 4,500 with comorbidities. The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of symptomatic COVID-19 confirmed by PCR (mild, moderate or severe) starting at least 14 days after the second study vaccination in serologically negative (for SARS-CoV- 2) adult participants at the beginning of the study.
The first provisional analysis is based on 43 cases, of which 36 cases of COVID-19 were seen in the placebo group versus 7 cases seen in the COVAXIN group, resulting in a one-time estimate of the vaccine’s effectiveness of 80.6%.
The interim analysis included a preliminary review of the safety database, which showed that serious, serious and physician-assisted adverse events occurred at low levels and were balanced between the vaccine and placebo groups. The conduct and monitoring of the study follow the guidelines of Good Clinical Practices and were outsourced to IQVIA.
The National Institute of Virology analysis indicates that vaccine-induced antibodies can neutralize variant strains in the United Kingdom and other heterologous strains, which was published in bioRxiv.
Bharat Biotech expects to share more 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 intermediate and final analysis will be shared through pre-publication servers, as well as submitted to a peer-reviewed journal for publication.
About COVAXIN
COVAXIN, COVID-19 vaccine from India by Bharat Biotech, is developed in collaboration with the Indian Medical Research Council (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety record of more than 300 million doses delivered.
In addition to generating a strong immune response against multiple antigens, COVAXIN is shown to generate responses from memory T cells to their multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a superior safety profile than many other vaccines, COVAXIN is packaged in multi-dose vials that can be stored from 2 to 8TheÇ.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of genetic therapies to cure blindness diseases and develop a life-saving vaccine for COVID-19. Our innovative modifying gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one for many” and our new biological product candidate aims to offer better therapy for patients with unmet diseases, such as wet age-related macular degeneration , macular diabetic edema and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN candidate vaccine for COVID-19 in the US market. For more information, visit www.ocugen.com.
About Bharat Biotech:
Bharat Biotech has established an excellent history of innovation with more than 145 global patents, a broad product portfolio with more than 16 vaccines, 4 biotherapeutics, registrations in more than 123 countries and World Health Organization (WHO) prequalifications. Located in Genome Valley in Hyderabad, India, a center for the global biotechnology industry, Bharat Biotech has built a world-class vaccine and biotechnology, product research and development, Biosafety Level 3 manufacturing and vaccine supply and distribution.
Having distributed more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for H1N1 influenza, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the first tetanus toxoid conjugate vaccine for typhoid fever.
Bharat’s commitment to global social innovation programs and public-private partnerships has resulted in the introduction of WHO prequalified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® to combat 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 manufacturer of rabies vaccines in the world. To learn more about Bharat Biotech, visit www.bharatbiotech.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements in accordance with the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “forecasts”, “believes”, “potential”, “proposed”, “continues”, “estimates”, “provides”, “expects”, “plans”, “intends,” “ Can “,” could “,” could “,” will “,” should “or other words that convey uncertainty about future events or results to identify these forward-looking statements. These forward-looking statements include information about qualitative assessments of available data, potential benefits, clinical trial expectations and expected time for clinical trial readings and regulatory submissions. This information involves risks and uncertainties that may cause actual results to differ materially from those expressed or implied in such statements. Risks and uncertainties include, among other things , the uncertainties inherent in research and development, including the ability to meet expected clinical outcomes, clinical trial start and / or completion dates, regulatory submission dates ia, regulatory approval dates and / or launch dates, as well as the risks associated with the preliminary and provisional data (including the Phase 3 provisional data that are the subject of this release), including the possibility of new unfavorable clinical trial data And additional analysis of existing clinical trial data; the risk that data from clinical trials may be 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 Bharat Biotech clinical trial data will be published in scientific journal publications and, if so, when and with what modifications; whether the US Food and Drug Administration (FDA) will be satisfied with the design and results of COVAXIN’s preclinical and clinical studies, which were conducted by Bharat Biotech in India; if and when any biological license and / or emergency use authorization requests may be filed in the United States for COVAXIN; if and when such applications can be approved by the FDA; FDA decisions that affect labeling, manufacturing processes, safety and / or other matters that may affect COVAXIN’s availability or commercial potential in the United States, including product development 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 section entitled “Risk factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements made in this press release are only valid as of the date of this press release. Except as required by law, we assume no obligation to update the forward-looking 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 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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