Cocrystal Pharma (NASDAQ: COCP) has received Institutional Review Board approval from Emory University School of Medicine to conduct a Phase 1b human challenge study of its oral antiviral candidate CDI‑988. The study will enroll up to 40 healthy volunteers aged 18‑49 and will use the norovirus GII.2 (Snow Mountain Virus) strain to assess safety, pharmacokinetics and early efficacy. Enrollment is slated to begin in the first quarter of 2026, with the primary endpoint being a reduction in clinical symptoms and secondary endpoints focusing on viral shedding and disease severity.
CDI‑988 is a first‑in‑class, orally administered broad‑spectrum antiviral that targets the highly conserved 3CL protease active site shared by norovirus strains, including the prevalent GII.4 and the re‑emerging GII.17 variants. The compound’s design is based on Cocrystal’s structure‑based discovery platform, which has previously delivered promising safety data in a Phase 1 study conducted in August 2025 and received FDA clearance to proceed with the challenge study in September 2025.
Norovirus remains a global public health challenge, causing an estimated 700 million cases worldwide and 21 million in the United States each year. No approved treatments or vaccines exist, making CDI‑988’s potential to prevent or treat the disease a significant unmet need. The Phase 1b study is a critical step toward demonstrating the drug’s safety and early efficacy, and a successful outcome could validate Cocrystal’s platform and open the door to non‑dilutive funding and partnership or licensing opportunities.
Cocrystal’s financial position underscores the importance of this milestone. The company has operated at a loss and has recently raised capital through a private placement and an SBIR grant to support its pipeline. Progress in the Phase 1b study will be closely watched by investors and potential partners, as it could provide the evidence needed to secure additional funding and accelerate the company’s path to commercialization.
Sam Lee, Cocrystal’s President and co‑CEO, said the Emory IRB approval “marks a significant milestone in advancing our Phase 1b norovirus challenge study.” James Martin, CFO and co‑CEO, added that CDI‑988 “may revolutionize the management of highly contagious norovirus outbreaks, offering a new layer of defense as a prophylactic or therapeutic.”
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