1. Cocrystal gains IRB approval for CDI-988 Phase 1b trial. 2. Enrollment for norovirus study set to begin Q1 2026. 3. CDI-988 could address global norovirus outbreak issues. 4. Over 700 million norovirus cases occur annually worldwide. 5. CDI-988 may significantly reduce norovirus infection symptoms.
FAQ
Why Bullish?
Approval of CDI-988's clinical trial opens market potential. Similar paths for biotechs led to price surges.
How important is it?
Clinical trial advancements directly enhance Cocrystal's valuation and market presence.
Why Long Term?
Successful Phase 1b could lead to eventual market approval. Historical trends show prolonged price growth post-approval.
Cocrystal Pharma Secures IRB Approval for CDI-988 Phase 1b Study
BOTHELL, Wash., Dec. 18, 2025 — Cocrystal Pharma, Inc. (Nasdaq: COCP) has announced that it has received approval from the Institutional Review Board (IRB) at Emory University School of Medicine to commence a Phase 1b human challenge study with its investigational antiviral drug, CDI-988. This pivotal study is designed to assess the efficacy of CDI-988 for both the prevention and treatment of norovirus infections. Subject enrollment for the study is anticipated to begin in the first quarter of 2026.
Details of the Phase 1b Study
CDI-988 represents the first oral broad-spectrum antiviral drug candidate aimed at tackling norovirus outbreaks, which currently have no approved treatments or vaccines available. The randomized, double-blind, placebo-controlled study will involve up to 40 healthy participants aged 18-49, who will be screened and intentionally infected with the norovirus GII.2 (Snow Mountain Virus).
- Primary efficacy endpoint: Reduction in clinical symptoms incidence.
- Secondary efficacy endpoint: Reduction in viral shedding and disease severity.
- Safety and pharmacokinetic profile of CDI-988 will also be evaluated.
Further study details can be found on clinicaltrials.gov.
Significance of the IRB Approval
Dr. Sam Lee, President and co-CEO of Cocrystal, remarked, “This approval from the Emory IRB marks a significant milestone in advancing our Phase 1b norovirus challenge study. We are very excited about collaborating with the Emory team, given their exceptional expertise in norovirus and experience in human challenge studies.”
Cocrystal's study aims to address the global burden of norovirus, which contributes to about 700 million cases globally each year. Dr. Lee emphasized the company's commitment to innovative solutions for norovirus outbreaks and chronic infections, especially in immunocompromised patients.
Potential Impact of CDI-988
According to James Martin, CFO and co-CEO of Cocrystal, “CDI-988 may revolutionize the management of norovirus, a highly contagious virus known for its rapid spread in various settings, including hospitals, schools, and cruise ships. Used as a prophylaxis, CDI-988 could provide a vital new layer of defense.”
The drug was developed using Cocrystal’s proprietary structure-based drug discovery technology. Notably, in August 2025, the company announced promising Phase 1 safety data across all dosage cohorts, including a maximum dose of 1200 mg. In September 2025, Cocrystal received a Study May Proceed Letter from the FDA.
Understanding Norovirus
Norovirus is a highly contagious virus that causes acute gastroenteritis symptoms such as nausea, vomiting, stomach pain, and diarrhea. Annually, it leads to approximately 200,000 deaths worldwide, with significant societal costs totaling around $60 billion. In the United States alone, norovirus accounts for approximately 21 million cases of acute gastroenteritis, resulting in about 109,000 hospitalizations and nearly 900 deaths each year.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company specializing in the discovery and development of novel antiviral therapeutics targeting infectious viruses, including noroviruses, coronaviruses, and hepatitis C viruses. The company utilizes unique structure-based technologies to create effective antiviral drugs. To learn more, visit www.cocrystalpharma.com.
Cautionary Statements
This article contains forward-looking statements regarding Cocrystal’s future plans and expectations, notably the initiation of the norovirus study in early 2026 and the potential of CDI-988. These statements may be influenced by various factors and uncertainties, including regulatory approvals and market competition. For comprehensive risk factors, please refer to Cocrystal's SEC filings.