Capeserod Hydrochloride

BOCA RATON, Fla., May 20, 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, yesterday presented two posters on celiac disease research at the 2024 Digestive Disease Week (DDW 2024) Conference in Washington, D.C. The presentations draw upon research from the robust clinical program investigating latiglutenase, an oral biotherapeutic being developed as a potentially first-in-class, targeted, oral biotherapeutic for celiac disease (CeD). The results from these presentations demonstrate potential for improved CeD diagnostics and clinical trial design. “These findings will enable us to better monitor celiac disease and refine the tools we use in its diagnosis,” said Jack Syage, Ph.D., President and Chief Scientific Officer of Entero Therapeutics. “The data that indicates significantly higher levels of gluten are required to revert serology to positive in CeD patients underscores a fundamental gap in our diagnostic capabilities. This discovery, combined with the introduction of the VCIEL scale, offers a more nuanced approach to assessing mucosal health, ultimately enhancing the accuracy of our diagnostic criteria and paving the way for more effective targeted therapies.” “This research is foundational to better understanding the triggers and intestinal damage of celiac disease through a quantitative lens,” stated James Sapirstein, Chief Executive Officer of Entero Therapeutics. “By quantifying the amount of gluten required to elicit an adverse immune response and measuring the underlying tissue alterations that lead to celiac symptoms, we can better design our phase 3 clinical trial and determine what constitutes meaningful change in disease severity in response to latiglutenase, our investigational therapeutic.” The first presentation, titled, “A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation,” highlights VCIEL, a novel quantitative composite scale, combining the histologic scales of villus height to crypt depth ratio (Vh:Cd) and density of intraepithelial lymphocytes (IEL). As there is currently no broadly accepted measure of mucosal injury, the VCIEL scale is designed to improve the sensitivity and accuracy of indicators measuring small intestinal mucosal health in CeD patients. As described in the poster, the VCIEL scale consistently showed improvements over the individual Vh:Cd and IEL measures across multiple studies, suggesting that VCIEL provides better statistical precision and may be more sensitive to histological changes than the traditional measures. The second presentation, titled, “Dynamics of Serologic Change to Gluten in Celiac Disease Patients,” details research examining the threshold of gluten intake required to elicit a positive serological response after a period of adherence to a gluten-free diet. Results from the study, which involved the largest database of CeD research, including data from two Phase 2 clinical trials for latiglutenase, determined that a higher gluten exposure level than previously estimated is necessary to induce seropositivity. These findings indicate that the reintroduction of gluten into the diet does not immediately manifest a positive serological response and underscores the potential inadequacy of the gluten quantities traditionally used in diagnosis. The research provides a more precise gauge of how much gluten intake is needed for an accurate diagnosis. Details on yesterday’s presentations are as follows: Presentation Title: A Composite Mucosal Scale for Celiac Disease Encompassing both Morphology and Inflammation Presenters: Jack Syage, PhD. President & Chief Scientific Officer, Entero Therapeutics; Jennifer Sealy-Voyksner, PhD., Vice President R&D, Entero Therapeutics Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 p.m. to 1:30 p.m. ET Presentation Title: Dynamics of Serologic Change to Gluten in Celiac Disease Patients Presenters: Jack Syage, PhD. President & Chief Scientific Officer, Entero Therapeutics; Jennifer Sealy-Voyksner, PhD., Vice President R&D, Entero Therapeutics Session Title: Celiac Disease and Gluten Related Disorders Date and Time: May 19, 2024, from 12:30 p.m. to 1:30 p.m. ET About Latiglutenase Latiglutenase is an orally administered mixture of two minimally systemically absorbed gluten-specific recombinant proteases being developed as an oral biotherapeutic for celiac disease. It has demonstrated efficacy in alleviating GI symptoms of celiac disease and protecting against intestinal damage in three Phase 2 trials. The Phase 3 clinical development plan for latiglutenase has been reviewed by the GI Division of the U.S. Food and Drug Administration (FDA) at the End of Phase 2 meeting with an agreed plan forward, with initiation of the Phase 3 trials expected in early 2025. About Celiac Disease Celiac disease is a chronic, hereditary autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing malabsorption, gastrointestinal dysfunction, and debilitating symptoms. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Celiac disease is a global disease and affects approximately 1% of the population worldwide and is increasing in prevalence with improved diagnostic tools and improved awareness. About Digestive Disease Week® Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at 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 three proprietary technologies: 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 . 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

In tandem with its makeover this week—which happened to occur during Celiac Awareness Month—Entero teamed up with patient advocacy organization Celiac Journey to put up a display raising awareness around celiac disease on the Nasdaq Tower in Times Square on Thursday. The company formerly known as First Wave BioPharma has found itself on dry land with a decidedly non-aquatic new moniker. The gastrointestinal disease-focused biotech will henceforth be known, fittingly, as Entero Therapeutics, it announced Thursday. The rename comes with a new logo, website and, as of Friday, stock ticker: Entero will now trade on the Nasdaq as “ENTO.” “The rebranding aligns our corporate identity with our mission of bringing to market new treatments for the gut and intestine,” CEO James Sapirstein said in the announcement. “We have accelerated this by adding latiglutenase to our pipeline. This is an opportunity to address significant medical need and market opportunity for celiac disease,” he continued. “As we prepare for a Phase 3 study with this program and advance our other drug candidates, we want to make sure that our branding better reflects the Company’s GI focus.” In tandem with its makeover this week—which happened to occur during Celiac Awareness Month—Entero teamed up with patient advocacy organization Celiac Journey to put up a display raising awareness around celiac disease on the Nasdaq Tower in Times Square on Thursday. Entero picked up latiglutenase in the recent merger between First Wave and ImmunogenX. The all-stock transaction was finalized in mid-March, when the combined company then known as First Wave also laid out its plans to license the biotherapeutic’s U.S. and Canada commercial rights to “a strategic global pharmaceutical company” and raise additional financing to fund its continued development, all of which it said are expected to close in the second half of this year. The FDA’s GI division has already reviewed the phase 3 trial plan for latiglutenase, according to the company, with the study set to begin early next year. Entero is aiming to be the first to win approval for a pharmacologic treatment for celiac disease. Aside from latiglutenase, Entero is also developing two other GI-related phase 2 assets. Last fall, it paid $500,000 up front to take over development of Sanofi’s capeserod, which the French pharma had previously tested in Alzheimer’s disease and urinary incontinence, but which Entero plans to apply to multiple gastrointestinal disorders, starting with gastroparesis. Meanwhile, Entero is developing adrulipase as a treatment for exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis. Though Entero has positioned the yeast-based formulation as a potential alternative to AbbVie’s Creon and other pig-derived pancreatic enzyme replacement therapies in the space, adrulipase was set back last summer by preliminary results of a small phase 2 trial in CF patients, in which “it is likely the primary efficacy endpoint was not achieved,” the company said at the time.