Zacks Small Cap Research – COCP: Phase 1 Single-Ascending Dose Cohort of CDI-988 Shows it is Safe and Well Tolerated… – Technologist

By David Bautz, PhD

NASDAQ:COCP

READ THE FULL COCP RESEARCH REPORT

Business Update

No Safety or Tolerability Issues for CDI-988 in SAD Cohorts

On July 18, 2024, Cocrystal Pharma, Inc. (NASDAQ:COCP) 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. CDI-988 is being developed as a treatment for both noroviruses and coronaviruses.

The Phase 1, single center, randomized, double blind trial is evaluating the safety, tolerability, and pharmacokinetics (including a food-effect cohort) of orally administered CDI-988 compared to placebo in healthy adults. 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 justify moving the compound into the multiple-ascending dose (MAD) portion of the Phase 1 study and the company is currently manufacturing drug product for MAD cohorts. We anticipate subject enrollment beginning in the fourth quarter of 2024.

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).

Conclusion

We’re pleased to see that CDI-988 was well tolerated in the first-in-human Phase 1 SAD trial and we look forward to its advancement into the MAD portion of the study later in 2024. We remind investors that we continue to anticipate topline results from the company’s Phase 2a human challenge study of CC-42344 in the second half of 2024. Now that CDI-988 has cleared the first hurdle in its development we have slightly increased our probability of approval which has increased our valuation to $7 per share.

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