Cocrystal Pharma Announces First-Patient-In for Phase 2a Human Challenge Study Evaluating Oral CC-42344 in Pandemic and Seasonal Influenza A
06 Dicembre 2023 - 2:00PM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) announces 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. This randomized, double-blind,
placebo-controlled study will evaluate the safety, tolerability,
viral and clinical measurements of influenza A infection in
subjects dosed with oral CC-42344 treatment.
“There is an urgent need for new oral antivirals
targeting pandemic and seasonal influenza that address drug
resistance. CC-42344 was discovered using our proprietary
structure-based drug discovery platform technology to inhibit the
viral replication process. The data from this proof-of-concept
clinical study will further validate CC-42344’s novel mechanism of
action,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We
expect to report topline data from this clinical trial in
2024.”
“We are excited about the potential CC-42344
holds to create a paradigm shift in the treatment of one the
world’s most common viral infections,” added James Martin,
Cocrystal’s CFO and co-CEO. “Currently approved antiviral
treatments for influenza are prone to viral resistance, increasing
the need for improved influenza treatments for patients that also
provide significant cost savings to the global healthcare
system.”
About CC-42344In 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. In
October 2023 Cocrystal received authorization from the United
Kingdom Medicines and Healthcare Products Regulatory Agency to
initiate a Phase 2a human challenge trial with CC-42344 as a
potential treatment for pandemic and seasonal influenza A.
About Seasonal InfluenzaEach
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 StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the initiation and characteristics of a Phase 2a study
for CC-42344 as a product candidate for oral antiviral inhibitor
for the treatment of pandemic and seasonal influenza A, the
potential efficacy and clinical benefits of, and market for, such
product candidate, and the expected results and topline data from
this clinical trial in 2024. 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 Phase 2a study
including recruiting volunteers and procuring materials for such
study by our clinical research organizations and vendors, and the
results of such 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, 2022. 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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