LAWRENCEVILLE, N.J.--(BUSINESS WIRE)--Ellodi Pharmaceuticals, a gastroenterology-focused specialty pharmaceutical company, today announced that Evan Dellon M.D, M.P.H, Professor of Gastroenterology at the University of North Carolina at Chapel Hill who served as the Primary Investigator for the Phase 2b study (FLUTE), will present two abstracts during the Digestive Disease Week 2021 virtual meeting on APT-1011 (fluticasone propionate oral disintegrating tablet). Professor Dellon will present one poster of distinction and one oral presentation during the meeting, which is being held from May 21 through May 23, 2021.
The poster of distinction will discuss the low rates of glucocorticoid-related adverse effects with long-term treatment of Eosinophilic Esophagitis (EoE) from results of 52 weeks of exposure with APT-1011 in the Phase 2b study. The oral presentation will discuss further analyses from the Phase 2b study that demonstrated improvement in patients with fibrostenotic features, including strictures and/or rings, after 12-weeks of induction therapy with APT-1011.
“We are encouraged by the long-term safety results from the FLUTE Trial and the improvement seen in patients with fibrostenotic complications, which are very difficult to treat,” said Dr. Gina Eagle, Vice President and Head of Research and Development at Ellodi Pharmaceuticals. “We are focused on making a difference for patients suffering from EoE, and look forward to sharing future data on APT-1011 as we continue to work towards a potential treatment option for patients suffering from this disease.”
Poster of Distinction
Low Rates of Glucocorticoid-Related Adverse Effects with Long-Term Treatment of Eosinophilic Esophagitis with Fluticasone Propionate Orally Disintegrating Tablet (APT-1011): Results From 52 Weeks of Exposure in a Phase 2b Trial (presentation number Fr172) will be presented on Friday, May 21, 12:15pm – 1:00pm.
Oral Presentation
Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) Improves Histologic, Endoscopic and Symptomatic Responses in Eosinophilic Esophagitis Patients with Fibro-Stenotic Features: Results from a Phase 2b Trial (session number 3355) will be presented on Saturday, May 22, 4:42pm – 4:56pm.
About Ellodi Pharmaceuticals
Ellodi Pharmaceuticals is a gastroenterology-focused specialty pharmaceutical company. The company was formed by TPG Capital in September 2020 through a transaction that spun-out select clinical assets from Adare Pharmaceuticals. Ellodi Pharmaceuticals is focused on the clinical development of APT-1011, a novel therapy in Phase 3 development for the treatment of Eosinophilic Esophagitis (EoE). Ellodi Pharmaceuticals has assembled a seasoned team with deep expertise in developing and commercializing innovative therapies for gastrointestinal disorders and rare diseases. With patients and caregivers at the center of every decision we make, we are focused on developing and delivering innovative therapies that can meaningfully improve and transform the lives of patients with EoE. Further information about Ellodi Pharmaceuticals can be found at www.ellodipharma.com.
About Eosinophilic Esophagitis
EoE is a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration of the esophagus. EoE prevalence rate in the US is estimated at 57 in 100,000 (Dellon E et al. 2014) and is evolving due to increasing awareness of the disease. The exact cause of EoE is unknown, however it is believed to be triggered by a variety of stimuli, including certain foods and environmental allergens. Symptoms of EoE in adults include dysphagia (difficulty or discomfort in swallowing) and, in severe cases, food impaction (obstruction of the esophagus by food) and strictures (narrowing of the esophagus due to scar tissue formation). Early diagnosis and treatment of EoE is important to prevent progression to fibrotic changes in the esophagus which may be only partially reversible. Current management of EoE includes food elimination diets, off label use of proton pump inhibitors, and glucocorticoid steroid formulations. Despite growing awareness of the condition and its massively underserved patient population, no FDA approved treatment exists today.
About APT-1011
APT-1011 is a novel, proprietary, oral disintegrating tablet delivering fluticasone propionate to the esophageal mucosa while minimizing residence time in the oral cavity. In earlier clinical trials, APT-1011 was shown to be effective in reducing esophageal eosinophil counts and endoscopic findings in adults with a diagnosis of EoE. APT-1011 is currently in Phase 3 development (FLUTE II), following successful completion of its Phase 2 study (FLUTE) in 2019. It has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug designation by the FDA and the European Medicines Agency (EMA).
