- Topline results from Phase 2a study expected to
be announced before year end -
Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the
“Company”), a clinical stage biotechnology company discovering and
developing novel antiviral therapeutics that target the
replication machinery of hepatitis viruses, influenza viruses
and noroviruses, announced today the commencement of
enrollment and initiation of patient dosing in its Phase 2a
clinical study evaluating CC-31244 for the treatment of hepatitis C
virus (HCV)-infected individuals.
Gary Wilcox, Vice Chairman and Chief Executive
Officer of Cocrystal, commented, “We are pleased to advance the
clinical development of our lead program, CC-31244 with the
commencement of enrollment and patient dosing in our Phase 2a
study. The start of this study represents an exciting clinical
milestone, and we look forward to announcing topline results before
the end of this year. Importantly, our team is diligently focused
on the successful completion of this Phase 2a study and we believe
the results will be integral in guiding our next phase of
development for our hepatitis C program.”
The Phase 2a open-label study is designed to
evaluate the safety, tolerability and preliminary efficacy of
CC-31244 with an approved HCV drug. Dr. Joel Chua, Institute of
Human Virology, University of Maryland Baltimore, will serve as the
Principal Investigator of the study. Enrolled subjects will
self-administer orally 400 mg of CC-31244 and a fixed dose
combination of sofosbuvir and velpatasvir for 14 days. After 14
days the subjects will continue the treatment for another 4 weeks
on the fixed dose combination of sofosbuvir and velpatasvir.
Subjects will be followed up until 24 weeks after the last dose of
sofosbuvir and velpatasvir to determine if they have achieved
sustained virologic response (SVR). Primary and secondary efficacy
endpoints are SVR at 12 weeks post-treatment (SVR12) and at 24
weeks post-treatment (SVR24), respectively.
Dr. Chua commented, “The need for treatment
options with ultra-short duration for individuals chronically
infected with hepatitis C remains a significant unmet need. We are
encouraged by the results that CC-31244 has demonstrated to date,
and I believe it has shown not only great potential, but also
tremendous promise in meeting the need for safe and rapid treatment
options.”
The Company previously reported positive data
from the Phase 1a/1b trial of CC-31244 for the treatment of chronic
hepatitis C infection. The Phase 1a/1b study was a randomized,
placebo-controlled, double-blind trial designed to evaluate single
and multiple ascending doses of CC-31244 for safety/tolerability,
pharmacokinetics, and antiviral activity in hepatitis C infected
patients. In Phase 1a, 30 healthy volunteers received single doses
(20-400 mg) of CC-31244, and 12 healthy volunteers received
repeated doses of CC-31244 (either 200 or 400 mg) for 7 days. In
Phase 1b, 15 patients with hepatitis C genotype 1 infection
received CC-31244 for 7 days (6, 400 mg daily; 6, 600 mg daily; 3,
200 mg twice daily).
As reported, there were no dose-limiting adverse
events, study discontinuations due to adverse events, or serious
adverse events. Viral load data showed that CC-31244 administered
once daily (400 mg or 600 mg) or twice daily (200 mg) for 7 days
had a substantial and durable antiviral effect, with an average
hepatitis C RNA viral load decline from baseline of 1000-fold by
Day 4. Interestingly, the mean viral load at 6 days after the last
dose persisted in the range of 100-fold below baseline. Hepatitis C
genotype 1b cell-based replicon assays using combinations of
CC-31244 with other classes of hepatitis C drugs showed additive
and synergistic effects of CC-31244, providing important
information for ultra-short therapy cocktail regimens.
For additional information about the 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 Hepatitis C Virus
Hepatitis C virus (HCV) 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 HCV 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. It is a broad-spectrum novel
non-nucleoside replication inhibitor of the hepatitis C virus.
Phase 1b studies in HCV-infected patients showed the largest
reduction in viral load of any non-nucleoside inhibitor tested to
date. CC-31244 is now in clinical trials as part of a cocktail for
ultra-short therapy of 2 to 6 weeks. The lead candidate for
influenza has advanced to IND-enabling studies. It is effective in
animal models against both the pandemic and seasonal strains of
influenza. In addition, the Company has a pipeline of promising
early preclinical programs. Two private investors own approximately
48% of the Company. Corporate investors include OPKO Health, Inc.,
Brace Pharma Capital, LLC and Teva Pharmaceuticals Industries, Ltd.
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 expectations regarding the manner of conducting and
future progress of the Phase 2a study, and our future success. 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 and the
ability of the clinical research organization conducting the Phase
2a study to recruit subjects. Further information on our risk
factors is contained in our filings with the SEC, including the
Prospectus Supplement dated 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) 475-8247
COCP@jtcir.com
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