NASDAQ:COCP
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Business Update
Phase 2a Trial of CC-42344 Extended
On December 31, 2024, Cocrystal Pharma, Inc. (NASDAQ:COCP) announced that the Phase 2a clinical trial of its oral PB2 inhibitor, CC-42344, will be extended due to unexpectedly low infection rates among trial participants that were challenged with a H3N2 influenza strain. The Phase 2a trial initiated in December 2023 and completed enrollment in May 2024 with 78 total participants. It is a single center study being conducted in the U.K. designed to test the safety, tolerability, pharmacokinetics (PK), antiviral activity, and clinical measurements of CC-42344.
The results of the trial showed that CC-42344 had a favorable safety and tolerability profile as no participants had serious adverse events or discontinued the trial due to drug-related adverse events, however due to the low infectivity rate the virology results were not interpretable. The company will be working with the contract research organization to amend the trial protocol to help ensure that there is a higher infectivity rate during the rest of the study. We anticipate the protocol amendment will be completed in time to continue the trial in mid-2025.
Background on CC-42344
CC-42344 is a broad-spectrum inhibitor of pandemic and seasonal strains of influenza A. It targets subunit PB2, which along with PA and PB1 forms the RNA-dependent RNA polymerase. This enzyme is essential for viral replication in cells by replicating the viral RNA segments and transcribing their genes, which makes it an attractive target for therapeutic intervention. The following figure shows CC-42344 binding to the highly conserved active site of the PB2 protein in different influenza strains.
Binding to this conserved active site leads to broad-spectrum antiviral activity against multiple Influenza A strains, including both pandemic and seasonal strains. The following table shows the strains that CC-42344 is active against, which includes strains that are resistant to oseltamivir and baloxavir.
CDI-988 Update
On January 8, 2025, Cocrystal announced results from the Phase 1 trial of CDI-988 for the prophylaxis and treatment of norovirus, coronavirus, and other viral infections. The results showed the drug had a favorable safety and tolerability profile for dosing up to 800 mg per day for 10 consecutive days. The company also announced that an additional cohort that will receive a dose of 1,200 mg and a shorter treatment duration of five consecutive days will be tested this quarter. In addition, Cocrystal is planning to initiate a human challenge study in norovirus-infected individuals later in 2025.
There are no approved therapies for norovirus infection, which is the most common cause of acute gastroenteritis. According to the Centers for Disease Control (CDC), there are an estimated 685 million cases and 200,000 deaths caused by norovirus infection each year worldwide. In the U.S., norovirus infection causes over 2 million outpatient clinical visits annually and approximately 100,000 hospitalizations. In December 2024 alone, there were a reported 900 cruise ship passengers sickened from norovirus outbreaks. In addition to potentially being utilized as a norovirus therapy, CDI-988 may be tested as a prophylactic to be used in population dense areas to prevent norovirus outbreaks (e.g., cruise ships, nursing homes, day cares, military installations).
Conclusion
While disappointing that the company wasn’t able to derive any virology data from the Phase 2a challenge study of CC-42344, it is still encouraging that the drug was well tolerated and had a favorable safety profile. We look forward to updates on that program as the company adds additional study subjects later this year. We’re equally encouraged by the positive Phase 1 data of CDI-988 as it too showed a favorable safety and tolerability profile. With both compounds showing encouraging safety and tolerability we have slightly increased their probability of approval, which has increased our valuation to $8.00 per share.
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