Cocrystal Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344
31 10월 2023 - 9:00PM
Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company)
announces receipt of authorization from the United Kingdom
Medicines and Healthcare Products Regulatory Agency (MHRA) to
initiate a Phase 2a human challenge trial with its broad-spectrum,
oral PB2 inhibitor CC-42344 as a potential treatment for pandemic
and seasonal influenza A. Cocrystal expects to begin treating
influenza-infected subjects in this trial during the fourth quarter
of 2023.
In late 2022 Cocrystal reported highly favorable
safety and tolerability results in the single-ascending and
multiple-ascending dose portions of the healthy volunteer Phase 1
trial conducted in Australia. The Phase 2a single-site,
double-blind, placebo-controlled human challenge trial will
evaluate the safety, viral and clinical measurements of orally
administered CC-42344 in subjects infected with influenza A.
“We are pleased to have met the regulatory
requirements of the MHRA to begin this Phase 2a human challenge
trial in the UK,” said Sam Lee, Ph.D., Cocrystal’s President and
co-CEO. “Influenza is a major global health threat that may become
more challenging to treat due to emergence of highly pathogenic
avian influenza viruses and resistance to approved influenza
antivirals. The need for new therapeutic and prophylactic
treatments is clear. Our encouraging Phase 1 data demonstrated that
CC-42344 has a favorable safety profile and is well-tolerated.
CC-42344 has the potential to be a best-in-class antiviral
treatment for pandemic and seasonal influenza infections.”
“We are closely working with a world leading
clinical research organization that is experienced in testing
infectious and respiratory disease antivirals using human challenge
clinical trials,” said James Martin, Cocrystal’s CFO and Co-CEO.
“Receiving authorization to move ahead with our Phase 2a trial is a
major step in our quest to bring CC-42344 to market and make a
meaningful contribution to improving health and reducing the cost
of care.”
About Seasonal Influenza Each
year there are approximately one billion cases of seasonal
influenza worldwide, 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 CC-42344CC-42344 was
discovered using Cocrystal’s proprietary structure-based drug
discovery platform technology and is a novel approach to treating
pandemic and seasonal influenza A. In vitro data show that CC-42344
is highly active against drug-resistant influenza A strains with a
high barrier to resistance, while also demonstrating favorable
pharmacokinetic and safety profiles.
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 StatementsThis 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 2a study
for CC-42344 and the potential efficacy and clinical benefits of
such product candidate and the demand for such a product. 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 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 2a clinical study for CC-42344,
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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