Cocrystal Pharma Receives HREC Approval to Initiate Phase 1 Study to Evaluate Oral Broad-Spectrum Coronavirus 3CL Protease Inhibitor CDI-988
May 31 2023 - 7:00AM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company)
announces approval from the Australian Human Research Ethics
Committee (HREC) to conduct a Phase 1 study with its novel, oral,
broad-spectrum 3CL protease inhibitor CDI-988 as a potential
treatment for COVID-19.
The Phase 1 randomized, double-blind,
placebo-controlled, dose-escalating study will assess the safety,
tolerability and pharmacokinetics of CDI-988 in healthy volunteers.
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and
other coronaviruses, and demonstrated a favorable safety profile
and pharmacokinetic properties supportive of daily oral dosing.
Cocrystal applied its proprietary drug discovery platform
technology to design this investigational drug candidate.
“We are excited to have accomplished this
milestone and look forward to initiating our CDI-988 clinical
program as an oral treatment for patients with COVID-19, as well as
demonstrating our drug discovery platform technology capabilities,”
said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “CDI-988 was
designed to bind to a highly conserved region of coronavirus and
other viral proteases. Recent findings from our preclinical studies
also show pan-viral activity against different RNA viruses,
enabling the potential for additional clinical benefits. Further
exploration of this pan-viral activity is ongoing.”
“Australia is the ideal location to conduct a
cost-efficient, high-quality study,” said James Martin, CFO and
co-CEO. “The Australian regulatory agency has streamlined the
pathway for early-stage clinical studies and their government
offers enticing financial incentives. We already have in place an
Australian subsidiary and a relationship with a local contract
research organization that we established with our influenza A
Phase 1 study.”
About SARS-CoV-2SARS-CoV-2 is
part of a family of coronaviruses that historically has been
associated with a wide range of responses in infected individuals,
ranging from no symptoms to severe disease that includes pneumonia,
severe acute respiratory syndrome (SARS), kidney failure and death.
By targeting the viral replication enzymes and protease, Cocrystal
believes it is possible to develop an effective treatment for all
illnesses caused by coronaviruses including COVID-19, SARS and
Middle East Respiratory Syndrome. Cocrystal is executing on a
strategy to develop highly potent and safe pan-coronavirus
antivirals for SARS-CoV-2 and its variants for hospitalized and
non-hospitalized patients, as well as for prophylactic use by
uninfected individuals.
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 influenza
viruses, coronaviruses (including SARS-CoV-2), 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 initiation
and characteristics of a Phase 1 study for CDI-988 and the
potential efficacy and clinical benefits of such product candidate.
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 arising from inflation, interest rate
increases, the recent banking crisis, the possibility of a
recession and the Ukraine war on our Company, our collaboration
partners, and on the U.S., Australia and global economies,
including manufacturing and research delays arising labor shortages
and other factors, the ability of our Clinical Research
Organization partner to recruit volunteers for, and to proceed
with, the Phase 1 clinical study for CDI-988, general risks arising
from conducting a clinical trial, receipt of regulatory approvals
for future trials, regulatory changes, development of effective
treatments and/or vaccines by competitors, including as part of the
programs financed by the governmental authorities, and potential
mutations in a virus we are targeting which may result in variants
that are resistant to a product candidate we may develop. 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, 2022. 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
Media Contact:JQA PartnersJules
Abraham917-885-7378Jabraham@jqapartners.com
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