Cocrystal Pharma Moves CDI-988 to Phase 1 Dose-Escalation

Sept. 26, 2024 -- Cocrystal Pharma, Inc. (Nasdaq: COCP) has announced the initiation of dosing for the multiple-ascending dose (MAD) segment of their Phase 1 clinical trial for CDI-988, an oral pan-viral protease inhibitor with broad-spectrum potential. The company anticipates releasing topline results from this study either late in 2024 or early in 2025. CDI-988 was created via Cocrystal’s proprietary structure-based drug discovery platform and represents a pioneering antiviral treatment aimed at combating both viral gastroenteritis and COVID-19 caused by noroviruses and coronaviruses, respectively.

Cocrystal’s President and co-CEO, Sam Lee, Ph.D., expressed enthusiasm about advancing CDI-988. He highlighted that the MAD results will provide further insights into the safety and tolerability of this innovative antiviral therapy, which targets viral proteases in noroviruses and coronaviruses.

The Phase 1 trial is a randomized, double-blind study conducted at a single site in Australia and is designed to assess the safety, tolerability, and pharmacokinetics of oral CDI-988 compared to a placebo in healthy volunteers. Earlier in July 2024, Cocrystal shared positive results from the single-ascending dose (SAD) portion of the trial, noting that all participants completed the study without serious adverse events or severe treatment-emergent adverse events. Additionally, no notable abnormalities were observed in laboratory tests, physical examinations, or electrocardiograms during the SAD portion.

Noroviruses are highly contagious, consistently evolving, and extremely stable in various environments, often leading to debilitating gastrointestinal illness characterized by symptoms such as vomiting, diarrhea, nausea, and abdominal cramps. The severity and duration of norovirus infections can be considerably worse for certain high-risk groups like infants, young children, the elderly, and individuals with compromised immune systems. According to the Centers for Disease Control and Prevention (CDC), noroviruses cause about 21 million acute gastroenteritis cases annually in the United States, resulting in 109,000 hospitalizations, 465,000 emergency room visits, and nearly 900 deaths. The National Institutes of Health (NIH) estimate the annual economic burden of noroviruses in the U.S. to be around $10.6 billion. Outbreaks predominantly occur in semi-enclosed settings like nursing homes, hospitals, cruise ships, schools, disaster relief sites, and military facilities. Currently, no antiviral treatments or vaccines are approved for norovirus infections.

Coronaviruses (CoV) encompass a range of viruses that can lead to symptoms from mild to severe, including pneumonia, acute respiratory distress syndrome (ARDS), kidney failure, and even death. Cocrystal aims to develop treatments targeting viral replication enzymes and protease, which could be effective against all coronaviruses, including SARS-CoV-2 (the virus responsible for COVID-19) and its variants, ARDS, and Middle East Respiratory Syndrome (MERS). The asymptomatic transmission capability of COVID-19 has further complicated public health efforts.

Cocrystal Pharma, Inc. is a biotechnology company in the clinical stage of development, focused on discovering and creating novel antiviral treatments that inhibit the replication of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses. The company leverages unique structure-based technologies and Nobel Prize-winning expertise to develop first- and best-in-class antiviral medications.