Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal”
or the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral therapeutics,
presented at the AASLD 2019 Liver Meeting being held November 8-12,
2019 in Boston, MA, new data in a poster demonstrating positive
data from its triple regimen, U.S. Phase 2a study evaluating
CC-31244 and sofosbuvir/velpatasvir (Epclusa) for the ultrashort
treatment of HCV infected individuals.
The poster titled, “Immune Cell Phenotypes
Associated with Successful Response to 2 Weeks of a Novel
Non-Nucleoside Inhibitor CDI-31244 Concurrent with 6 Weeks of
Sofosbuvir/Velpatasvir in Subjects with Chronic Hepatitis C
Genotype 1 Infection,” was presented by Joel Chua, MD, Assistant
Professor of Medicine of the Institute of Human Virology at the
University of Maryland School of Medicine and Principal
Investigator of the U.S. Phase 2a trial, on Sunday November 10,
2019 and is available on the Company’s website here.
“We are pleased with the new data from the U.S.
Phase 2a study that were presented this past weekend at the AASLD
2019 Liver Meeting. By investigating the association of specific
immune cell biomarkers with sustained virologic response (SVR) or
relapse in 12 treatment-native patients with chronic HCV genotype 1
infection without cirrhosis, we were able to successfully identify
patients that are more likely to respond to our shorter treatment
regimen,” commented Dr. Sam Lee, President of Cocrystal. “With the
data demonstrated to date, we believe that CC-31244 has the
potential to address the areas of unmet need that still exist in
the HCV treatment landscape including the high cost which acts as a
major barrier for treatment. We are grateful to Dr. Chua and his
team and look forward to advancing the development of CC-31244 and
its potential to offer ultrashort duration HCV therapy.”
Results from the Phase 2a study demonstrated
that eight of 12 (67%) patients achieved primary endpoint of
sustained virologic response (SVR) 12, which is considered a cure,
using only 6 weeks of Epclusa’s therapy combined with only 2 weeks
of CC-31244. Patients that achieved SVR had significantly higher
frequencies of terminally differentiated effector memory CD8+ T
cells compared with those who relapsed at both baseline and at
end-of-6-week treatment. At the same time, the frequency of naïve
CD8+ T cells was lower while the frequency of effector memory CD8+
T cells was higher in SVR patients; however, these differences were
not statistically significant. NK cell cytotoxic phenotypes
determined by measuring expression of TRAIL and CD107a also did not
differ between SVR and relapse patients, unlike another study that
evaluated a different regimen for 12 weeks.
CC-31244, an investigational, oral,
broad-spectrum replication inhibitor or NNI, has a high barrier to
drug resistance and is a highly potent, selective NNI that is
active against all HCV genotypes (1-6) with low level cytotoxicity
in multiple cell types. Epclusa 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.
In January 2019, Cocrystal announced safety and
preliminary efficacy data from its triple regimen, U.S. Phase 2a
study evaluating CC-31244. 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 the AASLD 2019 Liver
Meeting
AASLD is the leading organization of scientists
and health care professionals committed to preventing and curing
liver disease. AASLD was founded in 1950 by a small group of
leading liver specialists (including Hans Popper, Leon Schiff, Fred
Hoffbauer, Cecil Watson, Jesse Bollman, and Sheila Sherlock, to
name a few) to bring together those who had contributed to the
field of hepatology.
The annual AASLD Liver Meeting has grown to an
international society responsible for all aspects of hepatology,
and our annual meeting, AASLD, has grown in attendance from 12 to
more than 12,500 physicians, surgeons, researchers, and allied
health professionals from around the world. For more information,
please visit the conference website.
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 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 our beliefs regarding the potential
of 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, but are not limited to, risks arising general risks
arising from clinical trials, and receipt of regulatory approvals.
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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