Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on
discovering, developing, and commercializing gene therapies to cure
blindness diseases and developing 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 whole virion inactivated COVID-19
vaccine candidate. COVAXIN demonstrated a vaccine efficacy of 81%.
“We are thrilled with the interim efficacy results of Bharat
Biotech’s Phase 3 trial of COVAXIN in India. These results, which
in part suggest 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 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.
“Today’s results from the interim analysis of Bharat Biotech’s
Phase 3 trial 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
ability of antibodies induced by COVAXIN to neutralize the UK
variant of SARS-Cov-2,” said Dr. Bruce Forrest, member of the
vaccine scientific advisory board of Ocugen.
Interim Phase 3 Results as Reported by Bharat
Biotech
Bharat Biotech’s Phase 3 clinical trial enrolled 25,800
participants between 18-91 years of age, 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 occurrence of
PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with
onset at least 14 days after the second study vaccination in
serologically negative (to SARS-CoV-2) adult participants at
baseline.
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 review of the safety
database, which showed that severe, serious, and medically attended
adverse events occurred at low levels and were balanced between
vaccine and placebo groups. The trial’s conduct and monitoring are
as per Good Clinical Practice guidelines and have been outsourced
to IQVIA.
Analysis from the National Institute of Virology indicates that
vaccine-induced antibodies can neutralize the UK variant strains
and other heterologous strains, which has been published in
bioRxiv.
Bharat Biotech expects to share further details of the trial
results as additional data become 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 analyses
will be shared via pre-publication servers as well as submitted to
a peer-reviewed journal for publication.
About COVAXINCOVAXIN, India's COVID-19 vaccine
by Bharat Biotech, is developed in collaboration with the Indian
Council of Medical Research (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 track record of more than 300 million doses
supplied.In addition to generating strong immune response against
multiple antigens, COVAXIN is shown to generate memory T cell
responses, for its multiple epitopes, indicating longevity 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
2-8oC.
About Ocugen, Inc.Ocugen, Inc. is a
biopharmaceutical company focused on discovering, developing, and
commercializing gene therapies to cure blindness diseases and
developing a vaccine to save lives from COVID-19. Our breakthrough
modifier gene therapy platform has the potential to treat multiple
retinal diseases with one drug – “one to many” and our novel
biologic product candidate aims to offer better therapy to patients
with underserved diseases such as wet age-related macular
degeneration, diabetic macular edema, and diabetic retinopathy. We
are co-developing Bharat Biotech’s COVAXIN vaccine candidate for
COVID-19 in the U.S. market. For more information, please visit
www.ocugen.com.
About Bharat Biotech:
Bharat Biotech has established an excellent track record of
innovation with more than 145 global patents, a wide product
portfolio of more than 16 vaccines, 4 bio-therapeutics,
registrations in more than 123 countries, and World Health
Organization (WHO) Pre-qualifications. Located in Genome Valley in
Hyderabad, India, a hub for the global biotech industry, Bharat
Biotech has built a world-class vaccine & bio-therapeutics,
research & product development, Bio-Safety Level 3
manufacturing, and vaccine supply and distribution.
Having delivered more than 4 billion doses of vaccines
worldwide, Bharat Biotech continues to lead innovation and has
developed vaccines for influenza H1N1, Rotavirus, Japanese
Encephalitis, Rabies, Chikungunya, Zika and the world’s first
tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment
to global social innovation programs and public private
partnerships resulted in the introduction of path breaking WHO
pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV®
combatting polio, rotavirus, typhoid infections, respectively. The
recent acquisition of the rabies vaccine facility, Chiron Behring,
from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the
largest rabies vaccine manufacturer in the world. To learn more
about Bharat Biotech visit www.bharatbiotech.com.
Cautionary 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 “predicts,” “believes,” “potential,”
“proposed,” “continue,” “estimates,” “anticipates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “will,” “should” or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. Such forward-looking
statements include information about qualitative assessments of
available data, potential benefits, expectations for clinical
trials, and anticipated timing of clinical trial readouts 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. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, 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 that is the subject of this release), including the
possibility of unfavorable new clinical trial data and further
analyses of existing clinical trial data; the risk that clinical
trial data are subject to differing interpretations and
assessments, including during the peer review/publication process,
in the scientific community generally, 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 modifications; whether the U.S. Food and
Drug Administration (FDA) will be satisfied with the design of and
results from preclinical and clinical studies of COVAXIN, which
have been conducted by Bharat Biotech in India; whether and when
any biologics license and/or emergency use authorization
applications may be filed in the United States for COVAXIN; whether
and when any such applications may be approved by the FDA;
decisions by the FDA impacting labeling, manufacturing processes,
safety and/or other matters that could affect the availability or
commercial potential of COVAXIN in the United States, including
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 section entitled “Risk
Factors” in the quarterly and annual reports that we file with the
SEC. Any forward-looking statements that 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 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.
Ocugen Contact:Ocugen, Inc.Sanjay
SubramanianChief Financial Officer and Head of Corporate
Development ir@ocugen.comMedia Contact:For
Ocugen:LaVoieHealthScienceEmmie
Twomblyetwombly@lavoiehealthscience.com+1 857-389-6042Lisa
DeScenzaldescenza@lavoiehealthscience.com+1 978-395-5970
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