Cocrystal Pharma Announces Positive Phase 1 Results for CDI-988 Protease Inhibitor

Cocrystal Pharma, Inc. (Nasdaq: COCP), based in Bothell, Washington, announced encouraging safety and tolerability results from the single-ascending dose (SAD) cohorts of its Phase 1 study for CDI-988. The study involved healthy volunteers and focused on CDI-988, a potent oral pan-viral protease inhibitor. Created using Cocrystal's proprietary drug discovery platform, CDI-988 is designed to be a broad-spectrum antiviral targeting a highly conserved region of 3CL viral proteases. It aims to be the first dual antiviral treatment for norovirus and coronaviruses.

Sam Lee, Ph.D., President and co-CEO of Cocrystal, emphasized the significance of CDI-988's novel mechanism of action and broad-spectrum antiviral activity, calling it a promising candidate for advancing as an oral treatment for both noroviruses and coronaviruses. He expressed satisfaction with the favorable safety and tolerability data from the Phase 1 study and mentioned that the company is preparing for the multiple-ascending dose (MAD) cohorts, with subject enrollment expected to begin in the fourth quarter of this year.

The Phase 1 study, conducted in Australia, was a single-center, randomized, double-blind trial evaluating the safety, tolerability, and pharmacokinetics of CDI-988 in comparison to a placebo. Participants, who were healthy adults, received oral doses of CDI-988 ranging from 100 mg to 600 mg in the SAD cohorts. All participants completed the study without discontinuations, and there were no serious or severe treatment-emergent adverse events. No significant observations were reported from laboratory assessments, physical examinations, or electrocardiograms.

Noroviruses are highly contagious and constantly evolving, causing severe gastrointestinal symptoms such as vomiting and diarrhea. They pose a significant health risk, particularly to vulnerable groups such as infants, the elderly, and immunocompromised individuals. In the U.S., noroviruses are responsible for approximately 21 million cases of acute gastroenteritis annually, resulting in significant healthcare costs and nearly 900 deaths. Norovirus outbreaks commonly occur in semi-closed environments like nursing homes, hospitals, and schools. Currently, no antiviral treatment or vaccine is available for norovirus infections.

Coronaviruses, including COVID-19 and its variants, belong to a family of viruses that can range in severity from asymptomatic to causing severe diseases like pneumonia, acute respiratory distress syndrome (ARDS), and death. Cocrystal aims to develop an effective treatment for all coronaviruses by targeting viral replication enzymes and proteases. The ability of asymptomatic carriers to transmit COVID-19 has exacerbated public health challenges.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company focused on discovering and developing novel antiviral therapeutics. The company targets the replication processes of various viruses, including influenza, coronaviruses (such as SARS-CoV-2), noroviruses, and hepatitis C. Cocrystal employs unique structure-based technologies and expertise to create first- and best-in-class antiviral drugs.