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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.