- Data from 25,800 participants in the Phase 3 trial in India, receiving vaccine or placebo in a 1: 1 ratio, showed that the vaccine candidate is well tolerated and showed 81% efficacy to prevent COVID-19 in those without prior infection after the second dose.
- Clinical trials to proceed to the final analysis in 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 focusing on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, announced today that its co-development partner , Bharat Biotech, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a whole virion-inactivated COVID-19 vaccine candidate. COVAXIN has shown a vaccine efficacy of 81%.
“We are delighted with the interim efficacy results of Bharat Biotech’s Phase 3 study of COVAXIN in India. These results, which in part indicate a significant immunogenicity against the rapidly emerging British variant, represent a further step to set out the regulatory path for EUA and approval in the United States. “COVAXIN, a whole virion-based vaccine candidate, is designed to fill a significant unmet need in our national arsenal of vaccines against COVID-19,” said Dr. Shankar Musunuri, chairman of the board, chief executive officer and co-founder of Ocugen said. .
“The current results of the interim analysis of Bharat Biotech’s Phase 3 investigation of COVAXIN are a milestone in the development of another critical vaccine option for the US market. COVAXIN has been shown to elicit immune responses against several protein antigens of the virus, reducing the possibility of mutant virus escape. This range of immune responses is demonstrated by the ability of COVAXIN-induced antibodies to neutralize the British variant of SARS-Cov-2, ”said Dr. Bruce Forrest, a member of the vaccination advisory board against Ocugen, said.
Interim Phase 3 results as reported by Bharat Biotech
Bharat Biotech’s Phase 3 clinical trial enrolled 25,800 participants between the ages of 18-91, including 2,433 older than 60 and 4,500 with concomitant diseases. 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 serological negative (versus SARS-CoV – 2) adult participants at the starting line.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group compared to 7 cases observed in the COVAXIN group, which resulted in a score estimate of the vaccine efficacy of 80.6% .
The interim analysis included a preliminary review of the safety database, which showed that severe, severe and medically attended side effects occurred at low levels and were balanced between vaccine and placebo groups. The performance and monitoring of the trial are in accordance with the guidelines of good clinical practice and have been outsourced to IQVIA.
Analysis by the National Institute of Virology indicates that antibodies produced by vaccines can neutralize the British variety strains and other heterologous strains, published in bioRxiv.
Bharat Biotech expects to share further details of the trial 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 will be shared via servers prior to publication and will also be submitted to a peer-reviewed journal for publication.
About COVAXIN
COVAXIN, the COVID-19 vaccine from India by Bharat Biotech, was developed in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine manufactured using a vero-sel manufacturing platform with an excellent safety record of over 300 million doses supplied.
In addition to eliciting a strong immune response against multiple antigens, COVAXIN is shown to generate memory T cell responses for its multiple epitopes, indicating a long lifespan and a rapid antibody response to future infections. With published data showing a safety profile that is superior to several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8.oC.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company that focuses on discovering, developing and commercializing gene therapies to cure blindness diseases and develop a vaccine to save the lives of COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our new candidate for biological products is aimed at better treatment of patients with subarachnoid diseases such as wet age-related macular degeneration, diabetic macular to offer diseases. edema and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN vaccine candidate for COVID-19 in the US market. Visit www.ocugen.com for more information.
About Bharat Biotech:
Bharat Biotech has built an excellent record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutic agents, registrations in more than 123 countries and the previous qualifications of the World Health Organization (WHO). Bharat Biotech is located in the Genome Valley in Hyderabad, India, a hub for the global biotechnology industry, and has built a world-class vaccine and bio-therapeutic, research and product development, biosafety production 3 and the supply and distribution of vaccines. .
After delivering more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to innovate and develop vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus toxoid conjugate vaccine for typhus.
Bharat’s commitment to global social innovation programs and public-private partnerships has led to the launch of groundbreaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® that fight polio, rotavirus and typhoid infections, respectively. The recent acquisition of the rabies vaccine Chiron Behring from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine producer in the world. Visit www.bharatbiotech.com for more information on Bharat Biotech.
Warning about forward-looking statements
This press release contains forward – looking statements within the meaning of the Private Security Procedure Reform Act of 1995, which is subject to risks and uncertainties. In some cases we may use terms such as ‘predict’, ‘believe’, ‘potential’, ‘proposed’, ‘continue’, ‘estimate’, ‘expect’, ‘expect’, ‘plan’, ‘intend,’ “Power,” “can,” “power,” “will,” “must” or other words that convey uncertainty about future events or outcomes to identify these forward-looking statements, such forward-looking statements contain information about qualitative assessment of available data, potential benefits, expectations for clinical trials, and the expected timing of clinical trials and regulatory submissions.This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.Risk and uncertainties include more the uncertainties inherent in research and development in, including the ability to meet the expected clinical endpoints, start and / or completion dates for clinical trials, dates for submission v regulations, dates and / or release dates of the regulations, as well as risks associated with preliminary and interim data (including the phase 3 interim data that is the subject of this version), including the possibility of unfavorable new clinical trial data and further analyzes of existing clinical trial data; the risk of clinical trial data being 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 data from Bharat Biotech’s clinical trials will be published in scientific journal publications, and if so, when and with what amendments; 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; whether and when any permit for biological licenses and / or emergency permits may be submitted in the United States for COVAXIN; whether and when such applications can be approved by the FDA; FDA decisions that affect the labeling, manufacturing processes, safety and / or other issues that may 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 filing with 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 apply only to the date of this press release. Except as required by law, we accept no obligation to update forward-looking statements in this press release, whether due to new information, future events or otherwise, after the date of this press release.
Ocugen contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corporate Development
[email protected]
Media contact:
For Ocugen:
LaVoieHealth Sciences
Emmie Twombly
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+1 857-389-6042
Lisa DeScenza
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