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NASDAQ:COCP
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Business Update
Multiple Upcoming Catalysts
Cocrystal Pharma, Inc. (NASDAQ:COCP) has multiple upcoming catalysts over the next few months as it develops CC-42344 as a treatment for influenza and CDI-988 as a treatment for both coronavirus and norovirus infections.
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Before the end of 2024, we expect Cocrystal to report topline results from the Phase 2a clinical trial of CC-42344. It is a human challenge study being conducted in the U.K. in which subjects are infected with influenza A before being treated with CC-42344 or placebo.
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We anticipate the company filing an Investigational New Drug (IND) application in 2025 in order to conduct a late-stage study of CC-42344 in the U.S. In the first quarter of 2024, Cocrystal received feedback from the FDA regarding the regulatory requirements for a planned Phase 2b trial with CC-42344.
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In late 2024 or early 2025, we anticipate the company reporting topline and tolerability results from the multiple-ascending dose (MAD) cohorts of the Phase 1 clinical trial of CDI-988, the company’s broad-spectrum antiviral inhibitor of 3CL viral proteases. CDI-988 is being developed as a treatment for both noroviruses and coronaviruses.
In July 2024, Cocrystal reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 trial of CDI-988, the company’s broad-spectrum antiviral inhibitor of 3CL viral proteases. Doses of CDI-988 from 100 mg to 600 mg were evaluated in the SAD cohorts. The results of the study showed that all participants completed the trial with no discontinuations. In addition, there were no serious adverse events or severe treatment-emergent adverse events reported. Lastly, no clinically significant observations were seen in laboratory assessments, physical exams, or electrocardiograms. These results justified moving the compound into the MAD portion of the Phase 1 study.
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 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).