Cocrystal Pharma Provides Update on Influenza A Program
October 19 2020 - 8:05AM
Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or
the “Company”), announces promising in vitro and 7-day toxicity
data for its influenza A preclinical lead molecule, CC-42344, that
is currently being evaluated in IND-enabling studies for the
treatment of both seasonal and pandemic influenza strain A.
The Company’s fully owned drug candidate
CC-42344 is a potent, broad spectrum inhibitor of the influenza
replication enzyme targeting the PB2 subunit, and has strong
synergistic effects when combined with approved influenza antiviral
drugs including Tamiflu (oseltamivir) and Xofluza (baloxavir).
Cocrystal’s recent data shows that CC-42344 retained single digit
nanomolar potency (EC50 = 0.5 nM) against Xofluza (baloxavir)
resistant influenza A strain (H1N1, I38T). This can potentially
show CC-42344 drug superiority when seeking FDA approval.
Additionally, the Company reported a favorable safety profile from
the ongoing IND-enabling studies including 7-day rat and dog
toxicology studies, genotoxicity, and safety pharmacology. The
results show a no adverse effect level (NOAEL) of CC-42344 greater
than or equal to 1,000 mg/kg in both rat and dog. The Company plans
to complete the ongoing IND-enabling studies and enter into
clinical trials in 2021.
“We continue to make progress with this
important program and are working to finalize the Phase 1 study
protocol and initiate the Phase 1 study in 2021,” commented Sam
Lee, Ph.D., President of Cocrystal. “Influenza continues to be a
major global health concern, even during the current COVID-19
pandemic with authorities warning about a potential double pandemic
this upcoming flu season. We are encouraged by the recent in vitro
potency data of CC-42344 against the existing Xofluza (baloxavir)
H1N1 resistant strain containing mutation I38T and believe we have
the potential to significantly improve the treatment of
influenza.”
Cocrystal is applying its proprietary platform
technology to develop novel, broad spectrum influenza antivirals
that are specifically designed to be effective against all
significant A strains of the influenza virus and to have a high
barrier to resistance due to the mechanism used to target the
virus’s replication machinery. CC-42344, the Company’s lead
molecule for the treatment of influenza A, binds to a highly
conserved PB2 site on the influenza polymerase complex and exhibits
a novel mechanism of action that inhibits viral replication.
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 influenza
viruses, SARS-CoV-2 virus, hepatitis C viruses, and norovirus.
Cocrystal employs unique, proprietary, 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 related to our ability to
show CC-42344 drug superiority when seeking FDA approval and our
plans regarding the completion of the IND-enabling studies and the
beginning of clinical trials. 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
impact of the COVID -19 pandemic, the availability of products
manufactured by third parties, and the future results of
preclinical and clinical studies. Further information on our risk
factors is contained in our filings with the Securities and
Exchange Commission, including our Annual Report on Form 10-K for
the year ended December 31, 2019 and our Quarterly Report on Form
10-Q for the quarter ended June 30, 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 and Media Contact:
JTC Team, LLC(833) 475-8247COCP@jtcir.com
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