Cocrystal Pharma Engages CRO to Conduct Phase 2a Human Challenge Influenza A Clinical Trial with Novel, Broad-Spectrum Antiviral Candidate CC-42344
BOTHELL, Wash., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has engaged hVIVO, a subsidiary of London-based Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organization (CRO), to conduct a Phase 2a clinical trial with the Company’s novel, broad-spectrum, orally administered antiviral candidate CC-42344. This candidate represents a new class of investigational medicine designed to directly inhibit replication of the virus for the treatment of pandemic and seasonal influenza A.
“We are highly encouraged by the Phase 1 healthy volunteer trial results received so far and are committed to rapidly advancing this program into a human challenge Phase 2a trial in influenza A-infected subjects,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “The fact that influenza virus is constantly mutating against existing influenza antiviral drugs elevates an urgent need for effective antiviral therapeutics. CC-42344 is a broad-spectrum oral PB2 inhibitor that is highly active against drug-resistant influenza A strains. Further clinical development of CC-42344 offers an opportunity to address the need. Open Orphan is a world leader in conducting human challenge clinical trials with antiviral drug candidates, making it an ideal partner for conducting our Phase 2a trial.”
The single-center, double-blind, placebo-controlled Phase 2a human challenge trial is designed to evaluate safety, viral and clinical measures of orally administered CC-42344 to subjects challenged with influenza A. The trial is expected to be initiated in the second half of 2023, pending approval from the United Kingdom Medicines and Healthcare Products Regulatory Agency. This study will be conducted at hVIVO’s state-of-the-art facility in the United Kingdom.
Yamin “Mo” Khan, Open Orphan CEO, said, “We are pleased to be working with Cocrystal to evaluate its promising antiviral drug candidate for influenza A. A human challenge trial is an excellent option for Cocrystal, as it can rapidly provide efficacy data at a lower cost than traditional field trials.”
Cocrystal is conducting a Phase 1 study with CC-42344 in healthy subjects in Australia. The Company recently announced pharmacokinetic (PK) data supporting once-daily dosing from the single-ascending dose portion of this study. Enrollment in the multiple-ascending dose portion of the Phase 1 trial is ongoing, with full trial results expected in 2022.
About CC-42344 and Influenza
The global influenza therapeutics market is projected to reach $9.5 billion by 2027, from $6.6 billion in 2020, growing at a 4.8% CAGR between 2021 and 2027, according to a report published by Precision Reports in June 2022.
About hVIVO and Open Orphan plc
About Cocrystal Pharma, Inc.
Cocrystal Pharma Cautionary Note Regarding Forward-Looking Statements
# # #