Cocrystal Pharma Inc (NASDAQ:COCP) recently provided an update on initial observations from its preclinical trial of CC-42344, a molecule that it has been developing as a potential therapy for influenza.
The company revealed that the 7-day toxicity data that researchers observed from the preclinical studies was favorable. Cocrystal has been developing CC-42344 as a highly potent pipeline broad-spectrum inhibitor drug whose mechanism aims to inhibit the influenza replication enzyme. Cocrystal is currently running studies whose findings it plans to use in an IND filing for the drug as a treatment for pandemic and seasonal strains of influenza.
CC-42344 has so far demonstrated strong synergistic effects, especially when used as a combination therapy with other approved influenza therapies such as Xofluza (baloxavir) and Tamiflu (oseltamivir). The data that the company recently released indicates that CC-42344 had a single-digit nanomolar potency (EC50 = 0.5 nM) when used to treat H1N1, I38T, an influenza A strain that is resistant to Xofluza (baloxavir).
The study findings are expected to support regulatory filings
The company hopes that the FDA will use these findings to determine and understand CC-42344’s superiority to existing influenza treatments. Cocrystal also hopes that the data will be sufficient to warrant approval from the FDA. The biopharma is also confident that the strong safety profile observed in CC-42344 in the studies will also make a strong case to facilitate regulatory approval.
The safety pharmacology, genotoxicity, and toxicology studies that evaluated rats and dogs for 7 days did not yield any adverse effects. The company is currently working towards the completion of the ongoing preclinical studies before pushing into clinical trials next year.
“We continue to make progress with this important program and are working to finalize the Phase 1 study protocol and initiate the Phase 1 study in 2021,” said Dr. Sam Lee, the current president of Cocrystal.
Dr. Lee also noted that influenza is still a major health issue globally and it is particularly scary this year because the coming flu season will align with the ongoing global coronavirus pandemic. However, the recent findings indicate that the fight against influenza might become easier as more effective therapies such as CC-42344 go mainstream.