Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the
“Company”), a clinical stage biotechnology company discovering and
developing novel antiviral therapeutics, announced today that
it has commenced patient enrollment in its Phase 2a study in Hong
Kong SAR, China.
The Phase 2a open-label study being conducted at
Humanity & Health Research Centre, Humanity and Health Medical
Group, in Hong Kong will evaluate the safety, tolerability and
preliminary efficacy of Cocrystal’s CC-31244 in combination with
Sofosbuvir and Daclatasvir with or without a protease inhibitor,
for the treatment of hepatitis C (HepC). Sixteen patients will be
enrolled in the Phase 2a study. This trial differs from the current
Phase 2a trial Cocrystal is conducting in that testing will include
for the first time a protease inhibitor.
Dr. George Lau commented, “We are pleased to
commence patient enrollment in this important, differentiated Phase
2a study. I believe CC-31244 has the potential to be a shorter,
safer and more effective treatment option for treating hepatitis C
in the Asian population and where there remains a significant unmet
need.”
Gary Wilcox, Chairman and Chief Executive
Officer of Cocrystal stated, “The commencement of patient
enrollment in this Phase 2a study represents a noteworthy
accomplishment in our clinical development program for CC-31244. We
are pleased to be working with the Humanity & Health Research
Centre in Hong Kong and believe this study will provide valuable
insight in this important market, representing one of the largest
hepatitis C virus carrier populations in the world. We look forward
to further understanding the potential to change the treatment
paradigm for patients living with HCV by providing an ultra-short
therapy to enhance the existing HepC combination therapies.” Under
the Clinical Trial Agreement, the Phase 2a study of CC-31244 for
the treatment of HepC will be sponsored and conducted by the
Humanity & Health Research Centre, Hong Kong under the guidance
of George Lau, M.D., FRCP (Edin, Lond), FHKAM (Med), FHKCP, FAASLD,
Founding Chairman of Humanity and Health Medical Group, Hong Kong.
As part of the agreement, Cocrystal will provide CC-31244, its lead
product in development for HepC. Cocrystal’s CC-31244 is an
investigational, oral, potent, broad-spectrum replication inhibitor
called a non-nucleoside inhibitor (NNI). It has a high barrier to
drug resistance designed and developed using the Company's
proprietary structure-based drug discovery technology. It is active
against HCV genotypes 1-6 with no significant cytotoxicity in
multiple cell types at high concentrations.
About Humanity and Health Medical Group
(HHMG)
Humanity and Health Medical Group (HHMG) is a
private company, founded in 2009 by its Chairman, George Lau, MBBS
(HKU), M.D. (HKU), FRCP (Edin, Lond), FHKAM (Med), FHKCP,
FAASLD, who is also Chair Professor and co-Director, Liver Diseases
& Transplant Centre, The Fifth Medical Centre
of Chinese PLA General Hospital (former Beijing 302 Hospital),
Beijing - Humanity & Health Medical Group, Beijing,
China. HHMG provides high-end medical services to the community
mainly in Hong Kong SAR, and Beijing, China. HHMG, focuses on liver
diseases, gastrointestinal diseases, cardiovascular diseases,
respiratory medicine, oncology and general surgery. These medical
services are run by a group of senior specialist consultants,
including the former Clinical Professor and Chair Professor and
Dean of the HKU-LKS medical school, Hong Kong SAR, China,
facilitated by the “smart-health-care system,” a state-of-the-art
laboratory and imaging services. In addition, HHMG has been working
closely with Beijing 302 Hospital, Beijing to run combined clinics
and translational research center. With this collaboration, HHMG
has become the largest HCV treatment center and private HBV
treatment center, in Hong Kong. HHMG has also setup a clinical
trial center, named Humanity and Health Research Center (HHRC) to
do all Phase 2-4 US FDA-regulated and EU EMEA-regulated
registration clinical trials in Hong Kong, in full compliance to
ICH and GCH requirement.
About Cocrystal Pharma,
Inc.
Cocrystal Pharma, Inc. is a clinical stage
biotechnology company discovering and developing novel antiviral
therapeutics that target the replication machinery of influenza
viruses, 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. The
Company is developing CC-31244, an investigational, oral,
broad-spectrum replication inhibitor called a non-nucleoside
inhibitor (NNI). CC-31244 is currently being evaluated in a Phase
2a study for the treatment of hepatitis C as part of a cocktail for
ultra-short therapy of 4 to 6 weeks. Cocrystal recently entered
into an exclusive worldwide license and collaboration agreement
with Merck & Co., Inc. to discover and develop certain
proprietary influenza A/B antiviral agents. CC-42344, the Company’s
molecule for the treatment of influenza A, is currently being
evaluated in preclinical IND-enabling studies. In addition, the
Company has a pipeline of promising early preclinical programs and
continues to identify and develop non-nucleoside polymerase
inhibitors for norovirus gastroenteritis using the Company’s
proprietary structure-based drug design technology platform. For
further information about Cocrystal, please visit
www.cocrystalpharma.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including the prospects for CC-31244. 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 the
availability of products manufactured by third parties, issues with
the subjects selected by Dr. Lau’s company and the results which
arise in the Hong Kong trial including efficacy of CC-31244 in
combination with the other drugs. 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, 2018.
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 and Media
Contact:Jenene Thomas Communications, LLC(833)
475-8247COCP@jtcir.com
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