Cocrystal Pharma Announces Favorable Safety Data from the Phase 1 Study with Oral Antiviral CC-42344 for the Treatment of Pandemic and Seasonal Influenza A
November 17 2022 - 8:00AM
Cocrystal Pharma, Inc. (Nasdaq: COCP) today announced that CC-42344
demonstrated a favorable safety profile in both the
single-ascending dose and the multiple-ascending dose portions of
the ongoing Phase 1 study. CC-42344 is a broad-spectrum oral
antiviral for the treatment of pandemic and seasonal influenza A
with a novel mechanism of action.
“We are encouraged by the clean safety profile
observed with all dose levels in both the single-ascending and
multiple-ascending dose portions of the Phase 1 study, and we will
be assessing the pharmacokinetic data from this trial in the coming
weeks,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim
CEO. “We remain on track to reach an important milestone of
reporting topline Phase 1 study results later this year.
“Influenza is among the most serious global
public health threats, particularly with the emergence of pandemic
strains and resistance to available drugs,” he added. “Based on a
novel mechanism of action and a high barrier to resistance, we
believe CC-42344 holds potential to be a best-in-class oral
treatment for pandemic and seasonal influenza.”
The randomized, double-controlled,
dose-escalating Phase 1 study in Australia was designed to assess
the safety, tolerability and pharmacokinetics (PK) of orally
administered CC-42344 in healthy adults. In July 2022 Cocrystal
reported that PK data from the single-ascending dose portion of the
study support once-daily dosing. In October 2022 enrollment in the
multiple-ascending dose portion of the trial was completed. The
Company plans to present topline study results at the upcoming
World Antiviral Congress on December 1, 2022 and to submit an
application with the United Kingdom Medicines and Healthcare
Products Regulatory Agency to conduct a Phase 2a human challenge
study in early 2023. Subject to regulatory agency clearance, the
Phase 2a study is expected to be initiated in the second half of
2023.
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 Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding our being on
track to report topline results of the Phase 1 study later in 2022,
the potential of CC-42344 to be a best-in-class candidate 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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