Cocrystal Pharma Completes IND-enabling Studies with CC-42344 for the Treatment of Seasonal and Pandemic Influenza A, Plans t...
June 23 2021 - 8:00AM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal”
or the “Company”), a clinical-stage biotechnology company
discovering and developing novel antiviral therapeutics that target
the replication machinery of influenza viruses, coronaviruses,
hepatitis C viruses and noroviruses, announces the completion of
IND-enabling studies with its potent, broad-spectrum PB2 inhibitor
CC-42344 for the treatment of seasonal and pandemic influenza A and
plans to initiate Phase 1 clinical development of CC-42344 in the
third quarter of 2021.
“We are highly encouraged by the potential of
CC-42344 to treat seasonal and pandemic influenza, both of which
are major global health concerns,” said Sam Lee, Ph.D., Cocrystal’s
President and interim co-CEO. “We recently completed a 14-day GLP
toxicology study, which was the final pre-IND enabling step prior
to advancing this potent inhibitor into a first-in-human study.
“There is a pressing need for new antivirals to
treat influenza, as currently approved antiviral therapeutics are
prone to viral resistance,” added Dr. Lee. “CC-42344 stops the
first step of viral replication by binding to a highly conserved
PB2 site of the influenza polymerase complex that is essential to
replication. This uniquely positions CC-42344 to be an effective
therapeutic against all significant A strains of the influenza
virus, including avian pandemic strains as well as strains that are
resistant to Tamiflu® (oseltamivir) and Xofluza® (baloxavir
marboxil).”
“The planned Phase 1 study with CC-42344 will be
conducted in Australia, which offers favorable regulatory policies
and a clinical trial environment that aligns with our strategy for
quickly and cost-efficiently moving into clinical development,”
said James Martin, Cocrystal’s CFO and interim co-CEO. “The
Australian regulatory agency allows for a streamlined path for
early-stage study initiation and the Australian government offers
generous incentives for clinical studies performed in that country.
Importantly, clinical studies conducted in Australia have a
reputation for generating high-quality data. In preparing to
initiate this study, we have already established a subsidiary in
Australia and have selected a contract research organization.”
According to the World Health Organization (WHO)
estimates, approximately 1 billion people are infected with
seasonal influenza annually, resulting in 3 million to 5 million
cases of severe illness and 250,000 to 500,000 deaths worldwide.
Approved influenza therapies have limited efficacy due to drug
resistance and viral mutation.
About Cocrystal Pharma,
Inc.Cocrystal Pharma, Inc. is a clinical-stage
biotechnology company discovering and developing novel antiviral
therapeutics that target the replication process of coronaviruses
(including SARS-CoV-2), influenza viruses, hepatitis C viruses and
noroviruses. Cocrystal employs unique structure-based technologies
and Nobel Prize-winning expertise to create first- and
best-in-class antiviral drugs. For further information about
Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding our strategy with respect to the clinical development of
CC-42344, including the planned initiation of influenza A Phase 1
study in Australia in the third quarter of 2021, and the potential
of CC-42344 to treat seasonal and pandemic influenza. The words
"believe," "may," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "could," "target," "potential," "is likely,"
"will," "expect" and similar expressions, as they relate to us, are
intended to identify forward-looking statements. We have based
these forward-looking statements largely on our current
expectations and projections about future events. Some or all of
the events anticipated by these forward-looking statements may not
occur. Important factors that could cause actual results to differ
from those in the forward-looking statements include, but are not
limited to, the risks and uncertainties arising from the impact of
the COVID-19 pandemic on the Australian and global economy and on
our Company, including supply chain disruptions and our continued
ability to proceed with our programs, including our influenza A
program, the ability of the contract research organization to
recruit patients into clinical trials, the results of future
preclinical and clinical studies, and general risks arising from
clinical trials. Further information on our risk factors is
contained in our filings with the SEC, including our Annual Report
on Form 10-K for the year ended December 31, 2020. Any
forward-looking statement made by us herein speaks only as of the
date on which it is made. Factors or events that could cause our
actual results to differ may emerge from time to time, and it is
not possible for us to predict all of them. We undertake no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future developments or
otherwise, except as may be required by law.
Investor Contact:LHA Investor
RelationsJody Cain310-691-7100jcain@lhai.com
# # #
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From Apr 2023 to Apr 2024