Lawrenceville, N.J. – February 8, 2021 – Ellodi Pharmaceuticals, a gastroenterology-focused specialty pharmaceutical company, today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Eosinophilic Esophagitis (EoE), a rare, chronic allergic inflammatory disease characterized by eosinophilic infiltration of the esophagus.
Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs that are intended to treat or prevent serious conditions that have demonstrated the potential to address an unmet medical need. A drug that receives Fast Trackdesignation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the New Drug Application.1
“The FDA’s decision to grant APT-1011 Fast Track designation is an important milestone that underscores the strong unmet medical need to develop safe and effective therapies for EoE,” said Dr. Gina Eagle, Vice President and Head of R&D. “We are encouraged by the results of our clinical studies to date and believe APT-1011 has the potential to meaningfully improve the lives of patients suffering from this chronic and often debilitating disease. We look forward to working closely with the FDA to optimize and expedite the development of APT-1011.”
The Fast Track designation was granted based on data from the Phase 2b study (FLUTE) evaluating histological remission and symptomatic improvement after 12 weeks of treatment (induction), and the long-term maintenance of these improvements. Ellodi Pharmaceuticals’ ongoing Phase 3 clinical trial is evaluating the safety and efficacy of APT-1011 for both the induction of remission and long-term maintenance of remission in patients with EoE.
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.
APT-1011 is a novel, proprietary, oral disintegrating tablet designed to deliver 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 2), following successful completion of its Phase 2b study (FLUTE) in 2019. It has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
1U.S. Food and Drug Administration Fast Track: Fast Track | FDA