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Cocrystal Pharma Reports CC-42344 Pharmacokinetic Data in Influenza A Once-Daily Dosing

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Cocrystal Pharma (Nasdaq: COCP) has completed the single ascending dose portion of its Phase 1 study for the antiviral candidate CC-42344, showing favorable pharmacokinetic data that supports once-daily dosing potential. The study, conducted in Australia, aims to assess safety and tolerability in healthy adults. Preliminary data indicated a positive safety profile for doses of 100 mg and 200 mg. CC-42344 acts as a PB2 inhibitor and demonstrates antiviral activity against resistant influenza A strains, potentially outperforming existing treatments like Tamiflu.

Positive
  • Completion of single ascending dose portion of Phase 1 study for CC-42344.
  • Favorable pharmacokinetic data supports potential for once-daily dosing.
  • Demonstrated potent antiviral activity against influenza A strains resistant to existing treatments.
Negative
  • Forward-looking statements caution potential risks, including funding availability and patient recruitment challenges.

Single Ascending Dose Portion of Phase 1 Study Completed

BOTHELL, Wash., July 14, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that pharmacokinetic (PK) data from the single ascending dose portion of a Phase 1 study with its novel, broad-spectrum, orally administered antiviral candidate CC-42344 for the treatment of pandemic and seasonal influenza A support the potential for once-daily dosing. The single ascending dose portion of the Phase 1 study has been completed and subjects are currently being enrolled in the multiple ascending dose portion of the Phase 1 study.

“The PK data from single ascending dose portion of the trial mark a major milestone in the development of CC-42344’s as our drug holds potential to be administered once a day, less frequently than the leading influenza treatment Tamiflu®,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Unlike the mechanism of action of existing influenza A treatments, CC-42344 is a PB2 inhibitor that blocks an essential step of influenza viral replication and transcription. Completed in vitro testing demonstrated potent antiviral activity against prevalent influenza A strains resistant to the two approved influenza treatments Tamiflu® and Xofluza®.”

The randomized, double-controlled, dose-escalating Phase 1 study being conducted in Australia is intended to assess the safety, tolerability and pharmacokinetics of CC-42344 in healthy adults. In March 2022 Cocrystal announced the initiation of study enrollment and in April 2022 the Company announced preliminary Phase 1 data demonstrating a favorable safety and PK profile in the first two cohorts administered single ascending doses of 100 mg and 200 mg.

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 potential for CC-42344 to be developed for once-daily use and possible advantages over competitive treatments of influenza. 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 availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the COVID-19 pandemic including in Australia, the Russian invasion of Ukraine, and/or inflation and Federal Reserve interest rate increases in response thereto on the global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, the ability of the contract research organization to recruit patients into clinical trials, and the results of the multiple ascending dose portion of the Phase 1 study for CC-42344. 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, 2021. 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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FAQ

What is the recent development regarding Cocrystal Pharma's stock COCP?

Cocrystal Pharma announced the completion of the single ascending dose portion of its Phase 1 study for CC-42344, an antiviral candidate.

What are the potential benefits of CC-42344 for influenza treatment?

CC-42344 may allow for once-daily dosing and shows antiviral activity against strains resistant to treatments like Tamiflu.

What concerns did Cocrystal Pharma raise in their press release?

The company highlighted risks related to funding, patient recruitment, and the potential impacts of the global economy on its clinical programs.

Cocrystal Pharma, Inc.

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