Cocrystal Pharma Reports Highly Favorable Safety and Tolerability Results from a Phase 1 Study with its Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A
December 19 2022 - 8:00AM
Cocrystal Pharma, Inc. (Nasdaq: COCP) announces highly favorable
safety and tolerability results for its orally administered
replication inhibitor CC-42344 in its Phase 1 study. CC-42344 is a
broad-spectrum antiviral for the treatment of pandemic and seasonal
influenza A with a novel mechanism of action. The randomized,
double-controlled Phase 1 study was conducted in Australia to
evaluate the safety, tolerability and pharmacokinetics (PK) of
CC-42344 given orally at single doses up to 800 mg and daily doses
up to 14 days in 56 healthy volunteers.
Approximately 50% of the participants who
received a single dose of CC-42344 across all dose levels (100 to
800 mg) experienced adverse events, similar to the proportion of
placebo subjects who also experienced adverse events. In the
multiple-dose section of the study, the incidence of adverse events
was 67% for both CC-42344 (50 to 200 mg) and placebo. The vast
majority of adverse events were mild in severity. The most
frequently reported adverse event was headache, which occurred at
similar rates in CC-42344-treated and placebo-treated participants.
There were no serious adverse events or drug discontinuation due to
adverse events.
“We are encouraged by the highly favorable
safety and tolerability results from this first-in-human study with
CC-42344. These findings give us confidence to continue our
clinical testing of this compound as a potential treatment for
pandemic and seasonal influenza A,” said Sam Lee, Ph.D.,
Cocrystal’s President and co-interim CEO. “With these results our
influenza A program has achieved a major milestone and we look
forward to beginning a Phase 2a clinical study.”
Cocrystal plans to apply to the United Kingdom
Medicines and Healthcare Products Regulatory Agency to conduct a
Phase 2a human challenge study in early 2023. Subject to regulatory
clearance, the study is expected to be initiated in the second half
of 2023.
“On average about 8 percent of the U.S.
population contracts influenza each season according to the Centers
for Disease Control and Prevention. In addition to the health risk,
influenza is responsible for approximately $10.4 billion in direct
costs for hospitalizations and outpatient visits in the U.S.
annually. We are highly focused on advancing CC-42344 through the
clinical process and toward making a meaningful contribution to
improving health and reducing the cost of care,” said James Martin,
Cocrystal’s CFO and interim Co-CEO.
About CC-42344 CC-42344 is an
oral PB2 inhibitor discovered using Cocrystal’s proprietary
structure-based drug discovery platform technology. It is
specifically designed to be effective against all significant
pandemic and seasonal influenza A strains and to have a high
barrier to resistance due to the way the virus’ replication
machinery is targeted. CC-42344 targets the influenza polymerase,
an essential replication enzyme with several highly conserved
regions common to multiple influenza strains. In vitro testing
showed CC-42344’s excellent antiviral activity against influenza A
strains, including pandemic and seasonal strains, as well as
against strains resistant to Tamiflu® and Xofluza®, while also
demonstrating favorable PK and safety profiles.
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), 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 StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the potential of CC-42344 for the treatment of seasonal
and pandemic influenza, and our expectations and plans to submit an
application to the United Kingdom Medicines and Healthcare Products
Regulatory Agency to conduct a Phase 2a human challenge study in
early 2023 and to initiate the Phase 2a study in the second half of
2023. 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 any future impact of COVID-19 (including long-term or
pervasive effects of the virus), inflation, interest rate increases
and the war in Ukraine on the U.K. 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, 2021. 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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