- Data from 25,800 participants in the phase 3 trial in India, who received vaccine or placebo in a 1: 1 ratio showed that the vaccine candidate was well tolerated and demonstrated 81% efficacy in prevention of COVID-19 in those without previous infection after the second dose.
- The clinical trial will continue until the final analysis of 130 confirmed cases in order to collect more data and evaluate the efficacy of COVAXIN in other final criteria of the secondary study.
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 develop a vaccine to save lives from COVID-19, announced today that its development partner, Bharat Biotech , has announced the results of the first interim analysis of its phase 3 study of COVAXIN, a COVID-19 vaccinated candidate completely inactivated by virions. COVAXIN demonstrated a vaccine efficacy of 81%.
“We are delighted with the intermediate efficacy results of Bharat Biotech’s phase 3 COVAXIN trial in India. These results, which in part suggest significant immunogenicity against the rapid UK variant, represent an additional step towards to the US regulatory outline and approval in the U.S. COVAXIN, a comprehensive candidate for virion-based vaccine, is designed to meet a significant unmet need in our national COVID-19 vaccine arsenal. said Dr. Shankar Musunuri, chairman of the board, executive director and co-founder of Ocugen.
“Today’s results of the interim analysis of Bharat Biotech’s Phase 3 COVAXIN trial 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 chance of escaping the mutant virus. This range of immune responses has been demonstrated by the ability of COVAXIN-induced antibodies to neutralize the British variant of SARS-Cov-2, ”said Dr. Bruce Forrest, a member of Ocugen’s scientific vaccine advisory committee.
Provisional results of phase 3 according to Bharat Biotech reports
Bharat Biotech’s Phase 3 clinical trial associated 25,800 participants aged 18 to 91 years, including 2,433 over 60 years and 4,500 with comorbidities. The main endpoint of the phase 3 clinical trial is based on the first occurrence of symptomatic COVID-19 (mild, moderate or severe) confirmed by PCR with onset at least 14 days after the second study of serologically negative vaccination (a SARS-CoV- 2) adult participants at baseline.
The first provisional 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, which resulted in a timely estimate of the efficacy of the vaccine. 80.6%.
The interim analysis included a preliminary review of the safety database, which showed that serious, serious, and medically assisted adverse events occurred at low levels and were balanced between the vaccinated and placebo groups. The conduct and follow-up of the trial are in accordance with the guidelines of good clinical practice and have been subcontracted to IQVIA.
Analysis by the National Institute of Virology indicates that vaccine-induced antibodies can neutralize UK variant strains and other heterologous strains, which has been published in bioRxiv.
Bharat Biotech hopes to share more details of the test results as additional data become available. An additional interim analysis is planned for 87 cases and the final analysis for 130 cases. All data from the second interim and final analyzes will be shared through pre-publication servers and submitted to a peer-reviewed journal for publication.
About COVAXIN
COVAXIN, Bharat Biotech’s India COVID-19 vaccine, 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 that is manufactured with a vero cell manufacturing platform with an excellent safety history of over 300 million doses supplied.
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 longevity and a rapid antibody response to future infections. With published data demonstrating a higher safety profile than other vaccines, COVAXIN is packaged in multidose vials that can be stored at 2-8HeC.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing and marketing 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 candidate for biologics aims to offer better therapy to patients with low-grade diseases. treated, such as age-related macular degeneration, macular diabetes edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s candidate COVAXIN 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 world patents, a wide product portfolio of more than 16 vaccines, 4 biotherapies, registrations in more than 123 countries and World Health Organization pre-qualifications ( WHO). Located in the Genome Valley in Hyderabad, India, a hub for the global biotechnology industry, Bharat Biotech has built a world-class vaccine and biotherapy, product research and development, biosafety manufacturing and supply and distribution of vaccines.
Having administered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead the innovation and has developed vaccines against H1N1 flu, Rotavirus, Japanese encephalitis, rabies, Chikungunya, Zika and the first tetanus and toxoid conjugate vaccine for typhus.
Bharat’s commitment to global social innovation programs and public and private partnerships led to the introduction of pre-qualified WHO BIOPOLIO®, ROTAVAC® and Typbar TCV® vaccines that fight polio, rotavirus and typhoid infections, respectively. The recent acquisition of the rabies vaccine plant, Chiron Behring, of GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest manufacturer of rabies vaccines in the world. For more information on Bharat Biotech, visit www.bharatbiotech.com.
Caution 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. In some cases, we may use terms such as “predict,” “believe,” “potential,” “propose,” “continue,” “calculate,” “anticipate,” “expect,” “plan,” “intend,” Can, “could,” “could,” “wants,” or “should” or other words that convey uncertainty about future events or outcomes to identify these prospective statements. These forward-looking statements include information on qualitative evaluations of available data, potential benefits, expectations of clinical trials, and planned timing of clinical trial readings and regulatory presentations. This information carries risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, but are not limited to, the uncertainties inherent in research and development, including the ability to meet expected clinical criteria, start and / or end dates of clinical trials, regulatory submission dates. , the dates of regulatory approval and / or release dates, as well as the risks associated with the preliminary and provisional data (including the provisional data of phase 3 object of this version), including the possibility of new data of unfavorable clinical trials and additional analysis of existing clinical trial data; the risk that clinical trial data will be subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community at large and by regulatory authorities; if and when data from Bharat Biotech clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design and results of clinical and preclinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether an application for a biological product license and / or emergency use authorization in the United States may be submitted to COVAXIN and when it may be submitted; if and when these FDAs can approve these applications; FDA decisions affecting labeling, manufacturing processes, safety, and / or other issues that may 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 periodic submissions to 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 are only spoken from 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 not, after the date of this press release. press.
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