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 influenza viruses, coronaviruses, hepatitis C viruses
and noroviruses, announces progress in developing broad-spectrum
antiviral drug candidates that target coronaviruses including
SARS-CoV-2, the coronavirus that causes COVID-19. Cocrystal
initiated its COVID-19 program in March 2020 and has since expanded
the program with additional development and licensing.
“We are aggressively developing novel
coronavirus protease inhibitors for COVID-19 prophylactic and
therapeutic use,” said Sam Lee, Ph.D., President of Cocrystal.
“These drug candidates bind to a highly conserved region of the
active site of SARS-CoV-2 protease that is required for SARS-CoV-2
viral replication. Our high-resolution x-ray cocrystal structures
further confirmed the specific covalent interaction with this
conserved region of the proteases of the coronaviruses SARS-CoV-2,
SARS-CoV and MERS-CoV viruses.
“We believe that, due to their novel mechanism
of action, our protease inhibitors are likely to be effective
against new variants of SARS-CoV-2. This may include the recent
variants first identified in the United Kingdom, South Africa,
Brazil and India, which may be more contagious forms of the virus
and may evade immunity produced by vaccines or previous infection,”
he added.
Lead
candidate
CDI-45205
In December 2020 Cocrystal announced the
selection of CDI-45205 as its lead coronavirus development
candidate among a group of protease inhibitors obtained under an
exclusive license agreement with Kansas State University Research
Foundation (KSURF) announced in 2020.
CDI-45205 showed good bioavailability in mouse
and rat pharmacokinetic studies via intraperitoneal injection, and
also no cytotoxicity against a variety of human cell lines. The
Company recently demonstrated a strong synergistic effect with the
FDA-approved COVID-19 medicine remdesivir. Additionally, a
proof-of-concept animal study demonstrated that daily injection of
CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2
infected mice. Cocrystal has obtained promising preliminary
pharmacokinetic results and is continuing to further evaluate
CDI-45205.
“The immediate next steps in the process of
advancing this candidate toward clinical development require
scale-up synthesis and the subsequent manufacture of several
kilograms of the active pharmaceutical ingredient (API) to support
Investigational New Drug (IND)-enabling studies and Phase 1
trials,” said Dr. Lee. “Similar to our influenza CC-42344 program,
we are exploring multiple routes of administration of preclinical
lead molecules including oral, inhalation and injection. We will
also be examining in vitro activities of our compounds against the
SARS-CoV-2 variants.”
Novel SARS-CoV-2
replication inhibitors
Cocrystal has leveraged its antiviral
development expertise by using its proprietary technology and drug
discovery platform to launch a second COVID-19 program with
additional antiviral compounds developed.
“While we are highly encouraged by preclinical
progress with CDI-45205, we continue developing a new class of
SARS-CoV inhibitors. We applied our proprietary drug discovery
platform technology and high-throughput protein crystallography
approach to design new chemical scaffolds to improve in vitro
potency and pharmacokinetic properties,” explained Dr. Lee. “Lead
discovery and optimization are ongoing. We anticipate identifying
another SARS-CoV-2 preclinical lead for oral administration this
year. In addition to these two SARS-CoV-2 protease programs, we are
also developing novel SARS-CoV-2 inhibitors that block viral
replication and transcription. Our goal is to rapidly advance
multiple SARS-CoV-2 lead molecules to the clinical trial
stage.”
“Public health officials are calling for the
urgent development of potent antivirals that inhibit the
replication cycle of SARS-CoV-2,” said Gary Wilcox, Ph.D., Chairman
and Chief Executive Officer of Cocrystal. “Among the significant
challenges scientists face is inhibiting viral replication without
damaging the inner workings of healthy cells. Cocrystal’s approach
to drug discovery could provide a solution for designing antivirals
for use against a range of viruses, including coronaviruses, with
limited off-target interaction.
“Our established, proprietary drug discovery
platform is comprised of computation, medicinal chemistry and x-ray
crystallography together with extensive knowledge of viruses and
drug targets. This is a far different approach from traditional,
empirical, medicinal chemistry approaches that often require
iterative high-throughput compound screening and lengthy
hit-to-lead processes,” Dr. Wilcox concluded.
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 coronaviruses
(including SARS-CoV-2), 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. For further information about
Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements regarding the future
effectiveness of the protease inhibitors, including against new
variants of SARS-CoV-2, our expectations regarding the
identification of another SARS-CoV-2 preclinical lead for oral
administration, and the ability of our approach to drug discovery
to yield effective antivirals with limited off-target interaction.
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, the risks and uncertainties arising from the impact of
the COVID-19 pandemic on the national and global economy and on our
Company, including supply chain disruptions and our continued
ability to proceed with our programs, including our coronavirus
program, our ability to recruit patients into clinical trials, the
results of future preclinical and clinical studies, and general
risks arising from clinical trials. 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, 2020.
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
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