Cristcot to present CESSA corticosteroid data at DDW 2026
Cristcot, an Austin, Texas-based clinical-stage pharmaceutical company, has confirmed it will present an oral abstract at the 2026 Digestive Disease Week (DDW) Annual Meeting, running 2–5 May in Chicago. The presentation centres on findings from the company's CESSA Phase 3 trial in ulcerative colitis (UC), specifically examining the prevalence and pharmacokinetic consequences of undisclosed — or surreptitious — corticosteroid use among trial participants.
The abstract, titled Surreptitious Corticosteroid Use Identified by Formal Pharmacokinetic and HPA-Axis Testing in a Phase 3 Ulcerative Colitis Clinical Trial, will be delivered by Parambir Dulai, MD, on 5 May at 9:30am CDT. The presentation addresses a methodological challenge familiar to gastroenterology clinical researchers: patients enrolled in trials of novel UC therapies sometimes continue using corticosteroids without disclosing it to investigators, complicating the interpretation of efficacy and safety data.
The clinical question
Dr Raj Devarajan, Global Medical Advisor at Cristcot, said the pharmacokinetic and hypothalamic-pituitary-adrenal (HPA)-axis effects of exogenous corticosteroid use in inflamed intestinal mucosa remain poorly characterised. "This study offers a glimpse into the potential future of IBD research to more precisely examine Study Drug efficacy and safety without the interference of surreptitious use of corticosteroids," he said.
The CESSA trial is evaluating ngHCA, Cristcot's investigational hydrocortisone acetate 90 mg suppository formulation. ngHCA is administered via the Sephure applicator and is designed to deliver rapid, sustained-release topical corticosteroid action with limited systemic absorption. Cristcot says the formulation is designed to overcome adherence and delivery barriers associated with existing rectal therapies. If approved by the FDA, the company says ngHCA would be the first and only FDA-approved hydrocortisone acetate suppository in the United States.
Market context
Ulcerative colitis is a chronic autoimmune condition with no curative treatment. Cristcot notes that over 80% of patients experience at least two flares annually, and many cycle through therapies as disease activity fluctuates — a commercially significant pattern given the number of agents now competing for market share in the moderate-to-severe segment.
The broader UC treatment landscape has evolved substantially over the past decade, with multiple biologics and small-molecule agents — including JAK inhibitors and selective sphingosine-1-phosphate receptor modulators — now approved for maintenance therapy. Topical and rectal formulations occupy a distinct niche, particularly for patients with left-sided or proctitis-predominant disease, where local delivery can limit systemic exposure. The clinical question Cristcot is raising at DDW — how to identify and account for concomitant steroid use in trial populations — is relevant not only to its own programme but to the integrity of Phase 3 trial design across the UC space more broadly.
The DDW presentation does not constitute a full efficacy readout for ngHCA. Investors and clinicians should note that the oral abstract focuses on a safety monitoring methodology rather than primary endpoint data. Cristcot has not disclosed a PDUFA date or indicated when it expects to file a New Drug Application with the FDA. The company's pipeline also includes programmes in acute pancreatitis, haemorrhoid disease, and other inflammatory gastrointestinal indications, though these remain at earlier stages of development.