Cocrystal Pharma Receives Pre-IND Responses from the FDA on Oral CC-42344 for Treating Influenza A
19 Marzo 2024 - 1:00PM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) announces it has received Pre-Investigational New Drug
(Pre-IND) feedback from the U.S. Food and Drug Administration (FDA)
regarding CC-42344 as a potential oral treatment for pandemic and
seasonal influenza A. A Pre-IND review provides the opportunity to
obtain FDA guidance and clarification on critical steps such as the
proposed clinical trial design, as well as clinical drug
manufacturing and nonclinical studies deemed necessary before
filing the trial design. The feedback was provided in a written
response to a Pre-IND package and questions submitted by the
Company in January 2024.
“We value the FDA guidance as we prepare to file
the IND for our Phase 2b trial and open enrollment of patients in
the U.S.,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO.
“This is an important milestone that provides greater clarity on
the regulatory requirements and our planned oral CC-42344 clinical
program.”
A Phase 2a challenge study of oral CC-42344 is
underway in the United Kingdom to evaluate safety, and viral and
clinical measures in healthy volunteers who are infected with the
influenza A virus. The Company expects to report topline results
from this study in the second half of this year.
In addition, preparations are underway to begin
a Phase 1 study in Australia with the Company’s inhaled formulation
of CC-42344 as a potential influenza A treatment and prophylaxis
for those exposed to the virus. 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
InhibitorCC-42344 is a novel, broad-spectrum,
investigational antiviral candidate for the treatment of pandemic
and seasonal influenza A. CC-42344 inhibits the first step in the
viral replication process of influenza A by binding to a highly
conserved PB2 site of the polymerase complex that is essential to
replication. In vitro testing with CC-42344 showed 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
pharmacokinetic and safety profiles. In addition, oral CC-42344
demonstrated favorable safety and tolerability results in a Phase 1
study in Australia. This antiviral candidate was discovered using
the Company’s proprietary structure-based drug discovery platform
technology.
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 StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the expected results of the Phase 2a trial for CC-42344
for the oral treatment of influenza A in the second half of 2024,
efforts in preparation for an anticipated Phase 2b trial for oral
treatment of influenza A following the Phase 2a trial, efforts 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, 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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