Cocrystal finishes dosing Phase 1b norovirus trial
Cocrystal Pharma completes dosing in a Phase 1b human norovirus challenge study of CDI-988, with preliminary efficacy data expected around late 2026 to early 2027.
Rhea-AI Filing Summary
Cocrystal Pharma, Inc. (COCP) reported that the last subject has been dosed in its Phase 1b human norovirus challenge study (NCT07198139) evaluating its oral antiviral candidate CDI-988 for both prevention and treatment of norovirus infections. No serious adverse events have been reported in this study to date.
CDI-988, designed to inhibit viral replication across all known norovirus strains, previously completed a Phase 1 trial in Australia, where it was safe and well tolerated, including at the highest tested dose of 1200 mg. The ongoing Phase 1b randomized, double-blind, placebo-controlled study at Emory University enrolls healthy adults aged 18–49 infected with the GII.2 Snow Mountain Virus strain. Primary endpoints focus on reducing clinical symptoms versus placebo, with secondary endpoints including viral shedding, disease severity, safety, and pharmacokinetics.
Cocrystal stated that preliminary efficacy results from the Phase 1b study are expected in late 2026 or early 2027, which are anticipated to inform further clinical development of CDI-988 as a potential first-in-class oral antiviral for norovirus acute gastroenteritis.
Positive
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Negative
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8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Global annual norovirus cases: 685,000,000 cases
Global economic impact of norovirus: $60 billion
U.S. annual norovirus infections: 21,000,000 infections
+5 more
8 metrics
Global annual norovirus cases
685,000,000 cases
Estimated worldwide norovirus cases per year
Global economic impact of norovirus
$60 billion
Estimated worldwide annual economic burden of norovirus
U.S. annual norovirus infections
21,000,000 infections
Estimated norovirus infections per year in the United States
U.S. norovirus hospitalizations
109,000 hospitalizations
Estimated yearly norovirus-related hospitalizations in the United States
U.S. annual norovirus deaths
900 deaths
Estimated yearly norovirus-attributable deaths in the United States
CDI-988 dose in Phase 1b study
1200 mg
Highest Phase 1 dose established as safe and used in the Phase 1b challenge study
Phase 1b subject age range
18–49 years
Healthy adult subjects enrolled in the Phase 1b challenge study
Expected timing of preliminary efficacy results
Late 2026 to early 2027
Anticipated window for Phase 1b CDI-988 preliminary results
Key Terms
Phase 1b norovirus challenge study, norovirus acute gastroenteritis, viral shedding, pharmacokinetic profiles, +1 more
5 terms
Phase 1b norovirus challenge study medical
"the last subject has been dosed in its Phase 1b norovirus challenge study"
norovirus acute gastroenteritis medical
"first oral antiviral drug candidate developed for norovirus acute gastroenteritis"
viral shedding medical
"Secondary endpoints include reduction of viral shedding and disease severity"
Viral shedding is the process by which an infected person or animal releases virus particles into the environment, through actions like coughing, sneezing, breathing, or bodily fluids. It matters to investors because the amount and duration of shedding affect how contagious a disease is, the public health response, and regulatory safety assessments for vaccines or therapies; think of shedding like seeds being scattered, determining how far and easily an infection can spread.
pharmacokinetic profiles medical
"Secondary endpoints include reduction of viral shedding and disease severity, as well as safety and pharmacokinetic profiles"
Measurements and charts that describe how a drug moves through and leaves the body over time — including how quickly it is absorbed, how it spreads to tissues, how the body breaks it down, and how it is excreted. Think of it like a timeline showing blood levels after taking a pill, with key numbers such as peak concentration, total exposure, and half‑life. Investors use these profiles to gauge a drug’s dosing needs, safety window, development complexity, and how it compares to competing medicines.
double-blind, placebo-controlled medical
"The Phase 1b randomized, double-blind, placebo-controlled study was conducted"
A clinical trial design in which participants are randomly assigned to receive either the experimental treatment or an inactive substitute (a placebo), and neither the participants nor the researchers know who is receiving which. This setup limits bias and makes it far easier to tell whether a drug or intervention truly works, similar to a blind taste test, so results carry more weight for regulatory decisions and for investors assessing a product’s commercial prospects.
FAQ
What did Cocrystal Pharma (COCP) announce about its CDI-988 norovirus program?
Cocrystal Pharma announced that the last subject has been dosed in its Phase 1b human norovirus challenge study of CDI-988, an oral antiviral candidate being evaluated for both prevention and treatment of norovirus infections, with no serious adverse events reported so far.
What is CDI-988 and how has it performed in earlier trials for Cocrystal Pharma (COCP)?
CDI-988 is described as the first oral antiviral drug candidate developed for norovirus acute gastroenteritis, designed to inhibit viral replication in all known strains. In a prior Phase 1 trial in Australia, CDI-988 was reported as safe and well tolerated with no serious adverse events.
When does Cocrystal Pharma (COCP) expect Phase 1b results for CDI-988?
Cocrystal Pharma expects to report preliminary efficacy results from the ongoing Phase 1b norovirus challenge study of CDI-988 in late 2026 or early 2027, which are expected to guide decisions on further clinical development of the candidate.
What are the design and key endpoints of Cocrystal Pharma’s (COCP) Phase 1b CDI-988 study?
The Phase 1b study is randomized, double-blind, and placebo-controlled, conducted at Emory University School of Medicine in healthy subjects aged 18–49 infected with the GII.2 Snow Mountain Virus strain. The primary endpoint is efficacy versus placebo in reducing clinical symptoms, with secondary endpoints including viral shedding, disease severity, safety, and pharmacokinetics.
How large is the norovirus disease burden described by Cocrystal Pharma (COCP)?
Norovirus is described as causing an estimated 685 million global cases annually and a $60 billion worldwide economic impact. In the U.S., it is associated with about 21 million infections, 109,000 hospitalizations, and approximately 900 deaths each year.
What dose of CDI-988 is used in Cocrystal Pharma’s (COCP) Phase 1b challenge study?
Cocrystal states that a 1200 mg dose of CDI-988, previously established as safe in a Phase 1 dose-escalation study in healthy volunteers in Australia, is the dose being administered to healthy volunteers who are then infected with norovirus in the ongoing Phase 1b challenge study.
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