Entero Therapeutics Announces Peer-Reviewed Publication Unveiling Novel Algorithm for Measuring Intestinal Damage in Celiac Disease

New VCIEL scale provides a more sensitive and quantitative metric of small intestinal health for monitoring Celiac Disease severity and treatment efficacy

Special editorial highlights the potential importance of VCIEL for CeD research and clinical trials

BOCA RATON, Fla., June 27, 2024 (GLOBE NEWSWIRE) — Entero Therapeutics, Inc., (NASDAQ: ENTO), (“Entero Therapeutics” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced the publication of “A Composite Morphometric Duodenal Biopsy Mucosal Scale for Celiac Disease Encompassing Both Morphology and Inflammation” in Clinical Gastroenterology and Hepatology, a pre-eminent journal of the American Gastroenterological Association (AGA) that publishes innovative diagnostic and therapeutic advances in clinical gastroenterology.

As the number of promising therapies for celiac disease (CeD) grows, so does the need to improve the measurement of clinically relevant histological endpoints. The new approach presented in a peer-reviewed publication, led by Jack Syage, Ph.D., President and Chief Scientific Officer of Entero Therapeutics, recognized the need to advance beyond qualitative measures of histologic small intestinal health and to develop a more accurate and sensitive scale based on the independent quantitative measures of architectural changes (villus height to crypt depth ratio, Vh:Cd) and inflammation (intraepithelial lymphocyte count, IEL) already in use. The team created a composite score (VCIEL) for these two measures that helps overcome the individual variances to improve the overall accuracy of histological evaluation. The publication demonstrated the significant benefits of the VCIEL scale based on the results of four previous clinical trials. The significance of this achievement was highlighted in a special editorial feature by the journal, demonstrating the importance of this novel metric to CeD researchers.

“VCIEL can provide a higher predictive value to evaluate the efficacy of adjunct therapies in development,” stated Markku Mӓki, M.D., Ph.D., Faculty of Medicine and Health Technology at Tampere University and co-author of the publication. “We believe that using VCIEL will result in a more accurate histological assessment for CeD patients and greater sensitivity in measuring therapeutic benefit. With this approach, we anticipate an enhanced ability to address unmet need in the Celiac community.”  

“We believe the development of VCIEL represents a significant step forward in the management of Celiac Disease and offers new possibilities for improving patient care and treatment outcomes,” stated Dr. Syage. “Moving forward, we anticipate further validation of VCIEL through future clinical trials, including our Phase 3 latiglutenase study, with the aim of establishing a new gold standard for measuring clinically meaningful responsiveness to treatment.”

About Latiglutenase 
Latiglutenase, an oral biotherapeutic comprising two gluten-specific recombinant enzymes, is being developed to treat celiac disease in conjunction with a gluten-free diet. It has demonstrated efficacy in alleviating GI symptoms of celiac disease and preventing or improving intestinal damage in Phase 2 trials. The Phase 3 clinical program for latiglutenase is being discussed with the GI Division of the U.S. Food and Drug Administration (FDA), and the initiation of the Phase 3 trials is expected in early 2025.

About Celiac Disease 
Celiac disease (CeD) is a chronic, autoimmune disease in which eating gluten (a protein found in wheat, rye, and barley) causes damage to the lining of the small intestine, leading to malabsorption. CeD can present with highly variable gastrointestinal and extra-intestinal clinical manifestations, including anemia, chronic migraine, peripheral neuropathy, cognitive impairment, vitamin B-12 deficiency, unexplained infertility, and others that impact activities of daily living and increased healthcare costs. Currently, the only treatment for CeD is life-long adherence to a strict gluten-free diet. About one-third of patients on a gluten-free diet persist with symptoms or malabsorption signs. The seroprevalence of Celiac disease in adults is approximately 1.4% of the worldwide population.

About Entero Therapeutics, Inc. 
Entero Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around its proprietary technologies, including: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for Celiac disease; capeserod, a selective 5-HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency. Entero Therapeutics is headquartered in Boca Raton, Florida. For more information visit www.enterothera.com. 

Forward-Looking Statements 
This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether any financing or licensing transaction may be completed, completed with different terms, in an untimely manner, or not at all; whether the Company will be able to realize the expected benefits of its acquisition of  ImmunogenX; the Company’s ability to integrate the assets and contemplated commercial operations acquired from ImmunogenX into the Company’s  business; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether the Company will be able to maintain compliance with Nasdaq’s continued listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; the size of the potential markets for the Company’s drug candidates and its ability to service those markets; the effects of the First Wave Bio, Inc. acquisition, the related settlement and their effect on the Company’s business, operating results and financial prospects; and the Company’s current and future capital requirements and its ability to raise additional funds to satisfy its capital needs. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. 

For more information: 
Entero Therapeutics, Inc. 
777 Yamato Road, Suite 502 
Boca Raton, FL 33431 
Phone: (561) 589-7020 
info@enterothera.com

Media contact: 
Russo Partners
David Schull or Liz Phillips
(347) 956-7697
david.schull@russopartnersllc.com 
elizabeth.phillips@russopartnersllc.com