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Cocrystal Pharma's Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5N1 Avian Influenza Strain CC-42344 was shown to be highly active against the highly pa

Key Takeaway: Cocrystal Pharma announced that its investigational drug candidate CC-42344 has shown strong antiviral activity against the highly pathogenic H5N1 avian influenza strain. The virology study indicated that CC-42344 binds effectively to the PB2 protein of the virus, significantly outperforming the reference antiviral Tamiflu. This development comes amidst growing concerns about the H5N1 strain's potential for human-to-human transmission and the associated public health risks. Cocrystal is progressing with clinical evaluations of CC-42344 as a treatment option for both pandemic and seasonal influenza infections.

Market Sentiment Analysis

POSITIVE FACTORS

  • CC-42344 demonstrated strong antiviral potency against the H5N1 strain.
  • The drug has a favorable safety and tolerability profile in initial studies.
  • The results validate the company's structure-based drug discovery platform.
  • Potential to effectively address an emerging global health concern with influenza.

Full Press Release Details

Pharma's Investigational Drug Candidate CC-42344 Demonstrates Strong Antiviral Potency Against the 2024 Highly Pathogenic H5N1
Avian Influenza Strain
CC-42344 was shown to be highly active against the highly pathogenic 2024 Texas H5N1 avian influenza strain
The Company's virology study further confirmed the previous structural and in vitro data that revealed the binding of CC-42344 to PB2 protein of the 2024 H5N1 avian influenza virus
Wash. (May 29, 2025) - Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that a recent virology study showed its
novel, broad-spectrum influenza PB2 inhibitor CC-42344 exhibits strong antiviral activity against the highly pathogenic H5N1 avian influenza
A strain (A/Texas/37/2024).
March 25, 2024, the highly pathogenic avian H5N1 influenza virus was confirmed in a dairy cow in Texas and has continued to spread widely
in U.S. dairy cattle, causing a few human cases. There is concern that the H5N1 virus could adapt for human-to-human transmission and
potentially result in an influenza pandemic. CC-42344 is a new investigational drug candidate for the treatment of pandemic and seasonal
influenza infections. This inhibitor binds to a highly conserved active site of the PB2 protein and inhibits the viral replication process.
The Company previously announced the structural and in vitro data of CC-42344 with the purified H5N1 PB2 protein.
virology study utilized the highly pathogenic H5N1 avian strain (influenza A/Texas/37/2024) and was conducted to test antiviral activity
of CC-42344 using Tamiflu as a reference inhibitor. The data showed that CC-42344 was highly potent against the H5N1 avian influenza
virus (EC50, 0.003 M), approximately 1,000-fold more potent, compared to a refence compound Tamiflu (EC50, 2.69 M). CC-42344 is currently
in development as an oral treatment for pandemic avian and seasonal influenza A infections with initial data showing a favorable safety
and tolerability profile.
are excited to share these H5N1 results that further validate our structure-based drug discovery platform technology and strengthen our
position in developing treatments for influenza infection," said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. "These
important antiviral data along with the favorable safety profile observed in a Phase 1 study support further clinical evaluation of CC-42344
for pandemic and seasonal flu."
are developing a therapeutic candidate with the potential to address the multibillion-dollar influenza market," said James Martin,
CFO and co-CEO of Cocrystal Pharma. "Influenza is a major global health concern that may become more challenging to treat as highly
pathogenic avian viruses emerge and become resistant to approved antivirals. On average, in the U.S. about 8% of the population contracts
influenza each season and influenza is responsible for an estimated $11.2 billion in direct and indirect costs annually."
multistate outbreak of highly pathogenic avian influenza in dairy cows was initially reported in March 2024 and was the first time that
avian flu viruses were found in cows. In April 2024 the Centers for Disease Control and Prevention (CDC) confirmed an avian flu
infection in a person exposed to dairy cows that were presumed to be infected with the virus. This is believed to be the first instance
of likely mammal-to-human spread of this virus. In September 2024 the CDC reported the first human case of avian influenza without a
known occupational exposure to sick or infected animals.
CDC analyzed blood collected from people of all ages in all 10 Department of Health and Human Services regions during the 2022-2023 and
2021-2022 flu seasons. These samples were challenged with the avian flu subtype H5N1 virus to determine whether there was an antibody
reaction. Data from this study suggest that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in
the U.S. Antibody levels remained low regardless of whether or not participants received a seasonal flu vaccination, meaning that
seasonal flu vaccination did not produce antibodies to avian flu H5N1 viruses.
Cocrystal Pharma, Inc.
Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication
process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. 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,
Note Regarding Forward-Looking Statements
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including
statements regarding the potential efficacy of CC-42344 against influenza including the avian influenza A H5N1 virus and the potential
market for such product candidate. 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, risks
relating to our ability to obtain regulatory authority for and proceed with clinical trials including
our plans to complete a Phase 2a study for CC-42344, the results of such studies, our and our collaboration partners' technology
and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes
including based on initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory
approvals or limit access to federal funding for our programs, and potential development of effective treatments and/or vaccines by competitors
and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop.
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, 2024. 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.

Frequently Asked Questions

What is CC-42344?

CC-42344 is an investigational drug candidate developed by Cocrystal Pharma, targeting avian influenza.

How potent is CC-42344 against H5N1?

CC-42344 exhibits strong antiviral activity with an EC50 of 0.003 M, around 1,000-fold more potent than Tamiflu.

Is CC-42344 safe for use?

Initial data suggests a favorable safety and tolerability profile for CC-42344 in clinical studies.

What is the significance of H5N1 in the US?

The H5N1 virus is spreading in U.S. dairy cattle, raising concerns about potential human transmission.

What viruses does Cocrystal Pharma target?

Cocrystal Pharma develops antiviral therapeutics targeting influenza, coronaviruses, noroviruses, and hepatitis C.

Last updated: May 29, 2025