Enrollment Completed in Phase 2a Study with Cocrystal Pharma’s Oral Antiviral Candidate CC-42344 for Pandemic and Seasonal Influenza
May 01 2024 - 8:00AM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) announces completion of enrollment of 78 subjects who
were infected with influenza A in a randomized, double-blind,
placebo-controlled Phase 2a human challenge clinical study
evaluating the safety, tolerability, antiviral and clinical
measurements of its novel, broad-spectrum, oral PB2 inhibitor
CC-42344. CC-42344 is a new class of antiviral treatment designed
to effectively block an essential step in the viral replication and
transcription of pandemic and seasonal influenza A, and was
discovered using the Company’s proprietary structure-based drug
discovery platform technology.
“There is an urgent need for new influenza
antivirals targeting highly pathogenic avian pandemic and seasonal
influenza strains. It’s gratifying to report the timely completion
of enrollment in this important study, keeping us on track to
announce topline results later this year. This human challenge
study was conducted in the United Kingdom and was designed to
evaluate a favorable safety profile, virological effects, and an
improvement in clinical symptom for CC-42344 as a potential oral
treatment for avian pandemic and seasonal influenza A,” said Sam
Lee, Ph.D., Cocrystal’s President and co-CEO. “We are pleased to
advance our robust pipeline with achievement of this important
clinical development milestone as we continue to build our
leadership in influenza therapeutics.”
In March 2024 Cocrystal announced receipt of
positive Pre-Investigational New Drug (Pre-IND) feedback from the
FDA providing guidance and clarification on critical steps
including designing a proposed Phase 2b study protocol for CC-42344
as a potential oral treatment for pandemic and seasonal influenza
A.
Cocrystal also plans to begin a Phase 1 study in
Australia with an inhaled formulation of CC-42344 as a potential
influenza A treatment and post-exposure prophylaxis. Recent
preclinical data showed that inhaled CC-42344 exhibited highly
effective delivery into the lung, superior lung exposure, efficacy
in influenza-infected human lung epithelia and a favorable safety
profile.
CC-42344 Influenza A PB2
Inhibitor
In December 2023, Cocrystal announced the
achievement of first-patient-in for the Phase 2a human challenge
clinical trial with CC-42344, an investigational new oral antiviral
inhibitor for the treatment of pandemic and seasonal influenza A.
The randomized, double-blind, placebo-controlled study was designed
to evaluate the safety, tolerability, viral and clinical
measurements of influenza A infection in subjects dosed with oral
CC-42344 treatment. The study enrolled 78 healthy subjects.
In late 2022 Cocrystal reported favorable safety
and tolerability results in the single-ascending and
multiple-ascending dose portions of the healthy volunteer Phase 1
trial conducted in Australia. Preclinical data showed that
CC-42344 is highly active against seasonal and pandemic influenza A
strains.
About Seasonal Influenza
Each year there are approximately 1 billion
cases of seasonal influenza worldwide, with 3-5 million severe
illnesses and up to 650,000 deaths, according to the World Health
Organization. On average about 8% of the U.S. population contracts
influenza each season. In addition to the health risk, influenza is
responsible for approximately $10.4 billion in direct costs for
hospitalizations and outpatient visits for adults in the U.S.
annually.
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, 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, 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 the expected
timing and results of the Phase 2a trial for CC-42344 for the oral
treatment of influenza A in 2024, an anticipated Phase 2b trial for
oral treatment of influenza A following the Phase 2a trial, plans
to begin a Phase 1 study in Australia for an inhaled formulation of
CC-42344 as a potential influenza A treatment and prophylaxis, and
the potential efficacy and clinical benefits of, and market for,
such product candidates. 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 proceed with the studies including
recruiting volunteers and procuring materials for such studies by
our clinical research organizations and vendors, the results of
such studies and our ability to obtain FDA approval to initiate the
Phase 2b study. 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, 2023. 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
Media Contact:JQA PartnersJules
Abraham917-885-7378Jabraham@jqapartners.com
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