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Ellodi Pharmaceuticals Announces Phase 2b Data Presented at ACG 2020 on the Safety and Efficacy of Maintenance Treatment Following Induction of Remission in Eosinophilic Esophagitis with APT-1011

·4-min read

The abstract received ACG’s Category Award (Esophagus)

Ellodi Pharmaceuticals, a gastroenterology-focused specialty pharmaceutical company, today announced an oral presentation by Professor Evan Dellon M.D., M.P.H, at the American College of Gastroenterology (ACG) 2020 Annual Scientific Meeting and Postgraduate Course, highlighting the results of APT-1011 (fluticasone propionate oral disintegrating tablet) in a Phase 2b clinical study addressing the maintenance of remission following induction in Eosinophilic Esophagitis (EoE).

The abstract, titled "Safety and Efficacy of Long-Term Treatment of EoE with Fluticasone Propionate Orally Disintegrating Tablet (APT-1011): Results From 40 Weeks Treatment in a Phase 2b Randomized Double-Blind Placebo-Controlled Trial," received the Category Award (Esophagus) for the ACG annual meeting, which is being held virtually from October 23 to October 28, 2020.

Dr. Evan Dellon, Professor of Gastroenterology at the University of North Carolina, Chapel Hill served as the Primary Investigator for the Phase 2b study (FLUTE) and presented the supporting data for the long-term maintenance of symptomatic improvement with APT-1011 at 52 weeks, after achieving histological remission at 12 weeks.

All APT-1011 dose arms showed clinically meaningful and statistically significant achievement of histological remission with reduction of eosinophil counts in the esophageal mucosa, compared to placebo, at 12 weeks. This was accompanied by symptomatic improvement, as demonstrated by reduction in patient-reported disease symptoms, such as dysphagia events. These improvements were maintained over 52 weeks of treatment. APT-1011 was generally well tolerated.

"The rapid rise in the incidence and prevalence of EoE has outpaced the development of EoE-specific therapies, creating a significant unmet medical need for effective FDA approved treatments. The results of the FLUTE Trial suggest that APT-1011 could provide significant short-term and long-term histologic and symptomatic benefits to patients with EoE. I look forward to the continued development APT-1011 through its Phase 3 program," said Dr. Dellon.

"We are focused on making a difference for patients suffering from EoE and are particularly encouraged by the long-term results of the FLUTE Trial, as EoE is a chronic disease. We look forward to sharing future data on APT-1011 and the opportunity to provide a new potential treatment option for patients suffering from this chronic and often debilitating disease," said Dr. Gina Eagle, Vice President and Global Head of Clinical Development at Ellodi Pharmaceuticals.

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

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 I) in 2019. It has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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Courtney Power
media@tpg.com