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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): October 31, 2023
Cocrystal
Pharma, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38418 |
|
35-2528215 |
(State
or other jurisdiction |
|
(Commission |
|
(IRS
Employer |
of
incorporation) |
|
File
Number) |
|
Identification
No.) |
19805
N. Creek Parkway |
|
|
Bothell,
WA |
|
98011 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (786) 459-1831
N/A
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
COCP |
|
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
October 31, 2023, Cocrystal Pharma, Inc. (the “Company”) issued a press release announcing its receipt of authorization to
initiate a Phase 2a human challenge trial in the United Kingdom for its CC-42344 product candidate as a potential treatment for pandemic
and seasonal influenza A. A copy of the press release is being furnished as Exhibit 99.1.
Item
9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated:
October 31, 2023
|
Cocrystal Pharma, Inc. |
|
|
|
|
By: |
/s/
James Martin |
|
Name: |
James
Martin |
|
Title: |
Chief
Financial Officer and Co-Chief Executive Officer |
Exhibit
99.1
Cocrystal
Pharma Receives UK MHRA Authorization to Initiate Its Phase 2a Influenza Human Challenge Trial with Oral PB2 Inhibitor CC-42344
BOTHELL,
Wash. (October 31, 2023) – 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-42344
CC-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 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 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 Relations
Jody
Cain
310-691-7100
jcain@lhai.com
Media
Contact:
JQA
Partners
Jules
Abraham
917-885-7378
Jabraham@jqapartners.com
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Cocrystal Pharma (NASDAQ:COCP)
過去 株価チャート
から 5 2024 まで 6 2024
Cocrystal Pharma (NASDAQ:COCP)
過去 株価チャート
から 6 2023 まで 6 2024