Entero Therapeutics Presents Celiac Disease Research at 2024 DDW Conference

BOCA RATON, Fla., May 20, 2024 -- Entero Therapeutics, Inc., (NASDAQ: ENTO), a clinical-stage biopharmaceutical company specializing in targeted, non-systemic therapies for gastrointestinal (GI) diseases, presented two significant posters on celiac disease research at the 2024 Digestive Disease Week (DDW 2024) Conference in Washington, D.C. The research focused on latiglutenase, an innovative oral biotherapeutic being developed as a prospective first-in-class treatment for celiac disease (CeD). The findings from these studies highlight potential advancements in CeD diagnostics and clinical trial methodologies.

Jack Syage, Ph.D., President and Chief Scientific Officer of Entero Therapeutics, emphasized the importance of these discoveries, stating, "These results will help us better monitor celiac disease and enhance our diagnostic tools." He noted that the data reveals a significant gap in current diagnostic capabilities, with higher levels of gluten required to revert serology to positive in CeD patients. The introduction of the VCIEL scale, according to Syage, provides a more refined approach to evaluating mucosal health, thereby improving diagnostic accuracy and facilitating more effective targeted therapies.

James Sapirstein, CEO of Entero Therapeutics, highlighted the foundational nature of this research in understanding the triggers and intestinal damage associated with celiac disease. By quantifying gluten intake required to provoke an adverse immune response and assessing the tissue damage leading to celiac symptoms, the company aims to better design its phase 3 clinical trial. This will help determine what constitutes meaningful changes in disease severity in response to latiglutenase.

The first presentation, titled "A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation," introduces VCIEL—a composite scale integrating villus height to crypt depth ratio (Vh:Cd) and intraepithelial lymphocyte (IEL) density. This novel scale aims to improve the sensitivity and accuracy of mucosal injury indicators in CeD patients. The VCIEL scale demonstrated consistent improvements over individual Vh:Cd and IEL measures in several studies, indicating better statistical precision and higher sensitivity to histological changes.

The second presentation, "Dynamics of Serologic Change to Gluten in Celiac Disease Patients," explored the gluten intake threshold needed to elicit a positive serological response after adherence to a gluten-free diet. Research involving the largest CeD database, including data from two Phase 2 clinical trials for latiglutenase, indicated that higher gluten exposure than previously estimated is necessary to induce seropositivity. This finding underscores the inadequacy of traditional gluten quantities used in diagnosis and provides a more accurate measure of gluten intake necessary for diagnosis.

Latiglutenase, an oral biotherapeutic comprising two minimally systemically absorbed gluten-specific recombinant proteases, has demonstrated efficacy in alleviating GI symptoms and preventing intestinal damage in three Phase 2 trials. Entero Therapeutics plans to initiate Phase 3 trials in early 2025, following a review by the U.S. Food and Drug Administration's GI Division.

Celiac disease is a chronic autoimmune and inflammatory disease triggered by gluten consumption, resulting in damage to the small intestine lining, malabsorption, gastrointestinal dysfunction, and severe symptoms. It affects approximately 1% of the global population and is associated with numerous serious health complications if untreated.

Digestive Disease Week® (DDW) is the largest international gathering for professionals in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Sponsored by leading associations, DDW showcases over 5,600 abstracts and numerous lectures on the latest GI research and advancements.

Entero Therapeutics, headquartered in Boca Raton, Florida, is advancing its therapeutic pipeline with late-stage clinical programs, including latiglutenase for celiac disease, capeserod for gastroparesis, and adrulipase for exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients.

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