RARE Daily

TPG Forms Ellodi to Continue Development of Treatment for Eosinophilic Esophagitis

September 22, 2020

Rare Daily Staff

Private equity firm TPG Capital has formed a new specialty pharmaceutical company called Ellodi Pharmaceuticals dedicated to the clinical development of APT-1011, a novel therapy in late stage development for the treatment of eosinophilic esophagitis.

The formation of Ellodi Pharmaceuticals follows TPG Capital’s sale of Adare’s specialty CDMO pharmaceutical technology and microbiome businesses to Thomas H. Lee Partners and Frazier Healthcare Partners. As part of the transaction, TPG Capital retained ownership of APT-1011 and its related science with the intention to establish a new entity dedicated to the program’s continued development.

“Our clinical data provide diagnostic, histologic, and patient-reported evidence of safety and efficacy in the treatment of the eosinophilic esophagitis,” said John Schilling, partner at TPG Capital. “We look forward to completing the development of APT-1011 and the opportunity to bring this important therapeutic to the patients who are suffering from the disease.”

Eosinophilic esophagitis (EoE) is a rare, chronic, allergic inflammatory disease characterized by eosinophilic infiltration of the esophagus, which can lead to inflammation and ultimately strictures and narrowing of the esophagus, putting patients at risk of food impaction. EoE prevalence rate in the United States is estimated at 57 in 100,000 individuals 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. Currently in the United States, there are no therapeutic products approved for the treatment of EoE.

APT-1011 is a novel, proprietary, oral dosage form of fluticasone that allows for topical delivery of the drug to the esophagus whilst 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 being studied in a late-stage trial as a treatment for adults, adolescents, and children diagnosed with EoE. It has orphan drug status in the United States and European Union.

Ellodi will be headed by Troy Hamilton, previously Adare’s global head of specialty pharma. Hamilton has more than 25 years of experience in the biopharmaceutical and healthcare industries, including several executive and gastroenterology-related commercial leadership roles focused on functional gastrointestinal disorders, inflammatory bowel disease, EoE, short bowel syndrome, rare pediatric cholestasis, and acid-peptic disorders. Hamilton will continue to be supported by the program’s existing clinical team.

“EoE is a chronic condition that impacts a massively underserved patient population. Despite growing awareness of the disease, no approved treatment exists today,” said Hamilton. “The formation of Ellodi Pharmaceuticals marks an exciting milestone in our journey to bring this novel therapy to market. We are pleased to have the opportunity to dedicate even greater resources and expertise to the APT-1011 program and look forward to sharing our continued progress with the EoE community.”

Photo: Troy Hamilton, CEO of Ellodi Pharmaceuticals


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