Entero Therapeutics Publishes Peer-Reviewed Algorithm for Measuring Celiac Intestinal Damage

Entero Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on gastrointestinal (GI) diseases, has announced a significant advancement in the assessment of Celiac Disease (CeD). The company's new publication in Clinical Gastroenterology and Hepatology introduces the VCIEL scale—a composite morphometric duodenal biopsy mucosal scale that integrates quantitative metrics of both morphology and inflammation to better evaluate small intestinal health.

The development of VCIEL, led by Dr. Jack Syage, represents a shift from traditional qualitative assessments to a more nuanced and sensitive scale. This scale combines the villus height to crypt depth ratio (Vh:Cd) and the intraepithelial lymphocyte count (IEL), two independent quantitative measures already used in the field. The composite score of VCIEL aims to mitigate individual variances, thereby enhancing the accuracy of histological evaluations in CeD.

The importance of VCIEL was underscored in a special editorial by the journal, which highlighted its potential to advance CeD research and clinical trials. The publication drew on data from four previous clinical trials to demonstrate the scale’s efficacy and its ability to provide a more precise assessment of small intestinal health.

Dr. Markku Mӓki, a co-author of the study and a faculty member at Tampere University, emphasized VCIEL’s potential to offer higher predictive value in evaluating new therapies. He noted that the scale would likely improve histological assessments and increase sensitivity in measuring therapeutic benefits, addressing significant unmet needs within the celiac community.

Dr. Syage expressed optimism about VCIEL’s impact on patient care and treatment outcomes. The company plans to further validate the scale through upcoming clinical trials, including a Phase 3 study of latiglutenase, with the goal of establishing VCIEL as a new standard for measuring treatment responsiveness.

Latiglutenase, an oral biotherapeutic developed by Entero Therapeutics, is designed to be used alongside a gluten-free diet to treat CeD. The drug has shown promise in Phase 2 trials by alleviating gastrointestinal symptoms and preventing or improving intestinal damage. The Phase 3 clinical trials for latiglutenase are expected to begin in early 2025, pending discussions with the U.S. Food and Drug Administration (FDA).

Celiac Disease is a chronic autoimmune condition triggered by gluten, a protein found in wheat, rye, and barley. The disease causes damage to the small intestine, leading to malabsorption and a variety of symptoms ranging from gastrointestinal issues to cognitive impairments. The only current treatment is a strict, lifelong gluten-free diet, which is not entirely effective for about one-third of patients who continue to experience symptoms or signs of malabsorption. Approximately 1.4% of the global adult population is affected by CeD.

Entero Therapeutics is headquartered in Boca Raton, Florida, and specializes in developing targeted, non-systemic therapies for GI diseases. The company’s pipeline includes latiglutenase, capeserod for gastroparesis, and adrulipase for patients with exocrine pancreatic insufficiency due to conditions like cystic fibrosis and chronic pancreatitis.