- Hepatitis C program designed to
develop ultra-short treatment for hepatitis C virus (HCV)
consisting of CC-31244, an oral, potent, broad-spectrum
non-nucleoside inhibitor, as a part of combination therapy to
include approved HCV DAAs (direct antiviral agents)
Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or
the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral
therapeutics, today announced safety and preliminary
efficacy data for its U.S. Phase 2a study evaluating
CC-31244 for the ultra-short treatment of HCV infected
individuals.
CC-31244 is an investigational, oral,
potent, broad-spectrum replication inhibitor called a
non-nucleoside inhibitor (NNI). Epclusa (sofosbuvir/velpatasvir) is
an approved 12-week therapy for HCV developed by Gilead Sciences,
Inc. The U.S. Phase 2a study is an open-label study designed to
evaluate the safety, tolerability, and preliminary
efficacy of CC-31244 with Epclusa in 12 subjects with
treatment-naïve HCV genotype 1. Subjects received
oral 400 mg of CC-31244 and Epclusa for 2 weeks.
Following this, the subjects continued Epclusa treatment
alone for another 4 weeks. All subjects completed the
6-week treatment regimen. The treatment was well tolerated with no
study discontinuations due to adverse events. Eight of 12 subjects
achieved the primary efficacy endpoint of sustained virologic
response at 12 weeks after completion of treatment (SVR12). SVR12
is defined as undetectable virus in blood 12 weeks after completion
of treatment and considered a virologic cure.
“There is currently no approved HCV therapy of 6
weeks duration or less. We are encouraged by our preliminary
safety and efficacy data with CC-31244 and Epclusa showing no
drug-drug interactions and substantial efficacy. The
data obtained from this trial used 2 weeks of
CC-31244 in combination with Epclusa. Our future trials
may look to extend the duration of CC-31244 up to 6 weeks as
part of a combination therapy to evaluate whether such
a regimen will result in higher cure rates. We are
also pleased that the planned
investigator-sponsored trial is moving forward
in Hong Kong to continue to evaluate CC-31244 in
different combination therapies,” commented Dr. Gary Wilcox,
Vice Chairman and Chief Executive Officer of Cocrystal.
Joel Chua, M.D., Assistant Professor of Medicine
and Principal Investigator of the U.S. Phase 2a study at the
Institute of Human Virology, University of Maryland School of
Medicine, commented, “The short-term combination of CC-31244 and
Epclusa had a favorable safety profile and was very well tolerated
by all our participants in the study. A good portion of subjects
achieved SVR12 despite a very short duration of therapy.”
Plans are underway to
commence the second study in the HCV clinical
development program, a Phase 2a study in Hong
Kong evaluating the safety, tolerability and preliminary
efficacy of CC-31244 in combination with sofosbuvir and
daclatsavir with or without a protease inhibitor, for the
treatment of hepatitis C. The Humanity & Health
Research Centre expects to commence the study in
Q1 2019. The upcoming, Hong Kong Phase 2a open-label
trial differs from the current Phase 2a
trial Cocrystal is conducting by use of a protease
inhibitor as part of the combination regimen and a shorter
treatment duration.
For additional information about
the U.S. Phase 2a study of CC-31244 for the treatment of
viral hepatitis C, please visit ClinicalTrials.gov and
reference identifier NCT03501550.
About CC-31244
CC-31244 is an investigational,
oral, broad-spectrum replication inhibitor called
a non-nucleoside inhibitor (NNI). It
has been designed and developed using the Company's
proprietary structure-based drug discovery technology to
have a high barrier to drug resistance and to be
a highly potent, selective NNI that is active
against all HCV genotypes (1-6) with low level
cytotoxicity in multiple cell types.
About Epclusa
Epclusa, developed and marketed by Gilead
Sciences, Inc., is a fixed dose combination medication for the
treatment of hepatitis C. It combines sofosbuvir and velpatasvir.
It is more than 90% effective for hepatitis C genotypes one through
six. Treatment duration is 12 weeks. It also works for hepatitis C
in those who also have cirrhosis or HIV/AIDS. It is taken by mouth.
Epclusa is generally well tolerated. Common side effects include
headaches, feeling tired, trouble sleeping, and nausea. Sofosbuvir
works by blocking the NS5B protein and velpatasvir works by
blocking the NS5A protein. [1][2]
- Sofosbuvir/Velpatasvir for the treatment of Hepatitis
C". World Health Organization. Retrieved 29
June 2017.
- Sofosbuvir and Velpatasvir. The American Society of
Health-System Pharmacists. Retrieved 8
December 2017.
About Hepatitis C
Hepatitis C is a viral infection of the liver
that causes both acute and chronic infection, and according to the
World Health Organization in 2017, affects an estimated 71 million
people worldwide, including 3.5 million in the United States.
Chronic hepatitis C virus infection can lead to fibrosis
(scarring), cirrhosis, liver failure, and liver cancer.
Approximately 399,000 people die each year from hepatitis C, mostly
from cirrhosis and hepatocellular carcinoma.
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 hepatitis
viruses, influenza viruses, and noroviruses. Cocrystal employs
unique structure-based technologies and Nobel Prize winning
expertise to create first- and best-in-class antiviral drugs.
CC-31244 is in a Phase 2a trial as part of a cocktail for
ultra-short therapy of 6 weeks. It is a broad-spectrum novel
non-nucleoside replication inhibitor of the hepatitis C virus. The
Company’s lead candidate for influenza is effective in animal
models against both the pandemic and seasonal strains of influenza.
In a separate program, novel inhibitors effective against influenza
strains A and B have been identified and are in the preclinical
stage as part of a worldwide exclusive license and collaboration
agreement with Merck. In addition, the Company has a pipeline of
promising early preclinical programs. 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 our anticipated plans for future trials and expectations
regarding the timing for the initiation and future progress of the
Hong Kong Phase 2a study. 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, receipt of regulatory approvals and
the ability of the Hong Kong clinical research organization to
recruit subjects. Further information on our risk factors is
contained in our filings with the SEC, including our Quarterly
Report on Form 10-Q for the quarter ended June 30, 2018, the
Prospectus Supplements dated July 19, 2018 and April 30, 2018, and
our Annual Report on Form 10-K for the year ended December 31,
2017. 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
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From Apr 2024 to May 2024
Cocrystal Pharma (NASDAQ:COCP)
Historical Stock Chart
From May 2023 to May 2024