1Q24 Reported With Clinical Data Milestones On Schedule

3Q23 Reported As Three Trials Make Progress

Phase 2a Influenza Trial Receives Authorization To Begin

CDI-988 Begins Phase 1a/b Clinical Trial

Robert LeBoyer

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Biotechnology

Cocrystal Pharma Inc.

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Phase 1 Data Has Been Announced.&nbsp; In July 2022, Cocrystal announced pharmacokinetic data from its Phase 1 trial for CC-42344 in seasonal and pandemic influenza.&nbsp; CC-42344 is an inhibitor of the enzyme PB2 (polymerase basic 2), a subunit of the RNA polymerase required for the replication cycle of the virus.&nbsp; The PB2 enzyme is highly conserved between influenza strains and is needed for transcription of viral genes and early steps in viral replication.&nbsp; Blocking PB2 is an early point in the replication cycle that could allow CC-42344 to block production of all influenza strains.&nbsp; Previous in vitro data has also demonstrated potent antiviral activity against influenza strains resistant to the Tamiflu (oseltamivir) and Xofluza (baloxavir marboxil), two approved influenza treatments.
The Phase 1 data reported was from a randomized double-controlled study designed to determine pharmcokinetics, safety, and tolerability.&nbsp; The single ascending-dose portion showed that the once-daily dosing met its goals, confirming the expected response from once-daily administration.&nbsp; Patient enrollment continues in the multiple ascending dose portion.&nbsp; The company plans to present the study data at a medical meeting later in the year.
The Human Challenge Study Provides Advantages.&nbsp; The company has also announced plans to initiate a Phase 2a trial in 2023.&nbsp; This study is designed as a placebo-controlled, human challenge study that gives advantages over standard treatment designs or preventive trial designs.
The trial will recruit healthy patients, then administer of a dose of a well-characterized strain of influenza A.&nbsp; This eliminates many of the variables that would be expected if patients entered the study after community exposure, including the influenza strain, amount of viral exposure, and variability of symptoms.&nbsp; Providing a uniform, pharmaceutically prepared dose to healthy patients should give a consistent, predictable response.&nbsp; These factors allow the drug to be tested in a shorter and smaller trial than if patients were dosed after exposure to strains in the general environment.
Safety Precautions Are Including In The Trial Design.&nbsp; &nbsp;Clinical studies for infectious diseases often have severe or life-threatening symptoms that would prohibit infecting healthy subjects.&nbsp; Although influenza can be serious and cause death, the CC-42344 trial protocol includes sufficient patient monitoring and risk management precautions.&nbsp; If necessary, rescue medications such as Tamiflu are available and included in the treatment protocols.&nbsp; Cocrystal has contracted with hVIVO, a subsidiary of Open Orphan plc (AIM: ORPH), a CRO that has specialized in designing and conducting human challenge studies for numerous indications including respiratory diseases, infectious diseases, and influenza.
Study Treatment and Design.&nbsp; The study will be a single-center, placebo-controlled Phase 2a study.&nbsp; Subjects will be screened for previous exposure to the strain being given to ensure they are naÃ¯ve to the strain and have primary response to the virus.&nbsp; A standardized strain of influenza A will be administered on the first day.&nbsp; On the second day (24 hours later) the two groups will receive either CC-42344 or placebo once daily for 5 days.&nbsp; Since the administration of virus and the drug will be monitored, the timing, severity of symptoms, and responses can be documented over the course of the infection.&nbsp; Endpoints in the trial are reduction in viral load, safety, and tolerability.
The company expects the UKâ€™s Medicines and Healthcare Products Regulatory Agency to approve the design to begin the trial in mid-2023.&nbsp; The expected enrollment is about 20 to 40 subjects.&nbsp; We estimate the enrollment and treatment period at about 4 to 6 weeks, with results available about three months later.
Conclusion:&nbsp; After meeting the Phase 1 study dosing goals, Cocrystal has moved quickly to design and begin the Phase 2a study.&nbsp; The human challenge design removes many of the variables that would have required a larger number of patients.&nbsp; Importantly, it allows a robust infection followed by drug administration to provide data measuring response timeframes and biomarkers.&nbsp; This design should allow the study faster and at a lower cost than other designs.&nbsp; 
Cocrystal is also continues to make progress in its protease inhibitor programs in COVID-19 and norovirus. We are reiterating our Outperform rating and $5 price target on COCP.

Cocrystal Pharma Inc. (COCP)

Influenza Program Update

Fundamental Analysis:

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1Q24 Reported With Clinical Data Milestones On Schedule (COCP)

3Q23 Reported As Three Trials Make Progress (COCP)

Phase 2a Influenza Trial Receives Authorization To Begin (COCP)

CDI-988 Begins Phase 1a/b Clinical Trial (COCP)

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