Cocrystal Pharma Provides an Update on the Clinical Development of its Novel, Broad-Spectrum Antiviral Investigational Candidates
04 Gennaio 2024 - 2:00PM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the
“Company”) provides an update on the clinical development of its
oral first-in-class pan-norovirus and pan-coronavirus dual protease
inhibitor CDI-988 and its oral PB2 inhibitor CC-42344 for the
treatment of pandemic and seasonal influenza A. CDI-988 and
CC-42344 were specifically designed and developed using Cocrystal’s
unique structure-based drug discovery technology platform to be
effective on a broad range of viruses causing these diseases.
“We are encouraged that the preliminary data of
the ongoing Phase 2a and Phase 1 studies showed CC-42344 and CD-988
were well-tolerated with favorable safety profiles,” said Sam Lee,
Ph.D., Cocrystal’s President and co-CEO. “We see great promise with
both of these drug candidates as potential effective oral
treatments for highly contagious, pandemic viruses, while also
providing significant market opportunities for Cocrystal.”
CDI-988 targets a highly conserved region in the
active site of the main 3CL protease required for viral RNA
replication for pandemic norovirus and coronaviruses, including
SARS-CoV-2. CDI-988 is being evaluated for safety and
pharmacokinetics in a randomized, double-blinded,
placebo-controlled Phase 1 study in healthy subjects being
conducted in Australia. The Company reports favorable preliminary
data from the single-ascending dose cohorts of the clinical study.
Cocrystal expects to report topline results from the Phase 1 study
this year.
CC-42344 binds to a highly conserved PB2 site of
the influenza A polymerase complex and exhibits a novel mechanism
of action that inhibits viral replication. A randomized,
double-blind, placebo-controlled Phase 2a clinical study with
CC-42344 is underway in the United Kingdom. The Company reports
favorable tolerability and safety in the first cohort of the Phase
2a influenza A challenge study and expects to report topline
results from the Phase 2a clinical study this year. In 2022
Cocrystal reported favorable safety and tolerability results in the
healthy volunteer Phase 1 study with CC-42344 conducted in
Australia.
About Norovirus
Although norovirus is a worldwide public health
problem, there are no effective treatments or vaccines. Norovirus
afflicts an estimated 685 million people annually at an estimated
societal cost of $60 billion. About 200 million cases are seen
among children under 5 years old, leading to an estimated 50,000
child deaths every year, mostly in developing countries, according
to the Centers for Disease Control and Prevention (CDC). CDI-988 in
vitro studies showed potent broad-spectrum antiviral activity
against a panel of pandemic GII.4 norovirus proteases, which have
caused the majority of norovirus outbreaks worldwide since 2002,
and a favorable pharmacokinetic property targeting the
gastrointestinal tract.
About COVID-19 COVID-19
hospitalizations have recently increased in the U.S. with the new
JN.1 variant responsible for about 20% of these cases. Driven by
the anticipated emergence of new COVID-19 variants, the global
COVID-19 therapeutics market is estimated to exceed $16 billion by
the end of 2031. The ability of someone with no symptoms to
transmit infection to another person has heightened the public
health challenge of COVID-19. CDI-988 exhibited superior in vitro
potency against SARS-CoV-2 with activity maintained against
variants of concern. By targeting the viral replication protease,
Cocrystal believes it is possible to develop an effective treatment
for all coronaviruses, including COVID-19 and its variants, as well
as for Severe Acute Respiratory Syndrome (SARS) and Middle East
Respiratory Syndrome (MERS).
About Seasonal Influenza Each
year there are approximately 1 billion cases of seasonal influenza
worldwide, with 3-5 million severe illnesses and up to 650,000
deaths, according to the World Health Organization. On average
about 8% of the U.S. population contracts influenza each season. In
addition to the health risk, influenza is responsible for
approximately $10.4 billion in direct costs for hospitalizations
and outpatient visits for adults in the U.S. annually.
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) noroviruses and
hepatitis C viruses. 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 StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the promise and potential of the two product candidates,
the clinical development of CC-42344 as a product candidate for
oral antiviral inhibitor for the treatment of pandemic and seasonal
influenza A and the Phase 2a study for such product candidate,
CC-988 as a product candidate for dual oral antiviral inhibitor for
the treatment of coronavirus and norovirus and the Phase 1 study
for such product candidate, the potential efficacy and clinical
benefits of, and market for, such product candidates, and the
expected results and topline data from these clinical trials in
2024. 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 relating to our ability to
proceed with the studies including recruiting volunteers and
procuring materials for such studies by our clinical research
organizations and vendors, and the results of such studies. 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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