BLUE BELL, Pa.--(BUSINESS WIRE)--Ellodi Pharmaceuticals, a gastroenterology-focused specialty pharmaceutical company dedicated to the continued development of APT-1011, a novel, investigational oral therapy for the treatment of Eosinophilic Esophagitis (EoE), announced today that Debra Silberg, MD, PhD, FACG has joined the company’s board of directors. Dr. Silberg will also serve as a Scientific Advisor.
Dr. Silberg is an accomplished life sciences executive with deep experience across all stages of drug development. She serves as a Scientific Advisor to multiple pharmaceutical companies and has held clinical leadership roles at AstraZeneca, Shire, and most recently, Takeda, where she served as the company’s Global Vice President of Clinical Development and Clinical Science Head for Gastroenterology. In this role, she was responsible for the Gastrointestinal (GI) program team, which included approximately 30 physicians and clinical scientists across the US, Europe, China, and Japan who were focused on several GI diseases, including EoE. Additionally, Dr. Silberg oversaw the clinical aspects and led discussions with regulatory authorities (FDA and EMA) to facilitate the advancement of numerous GI development programs.
“This is an exciting time to be joining the Ellodi board," said Dr. Silberg. "I look forward to working with my fellow directors to support the Ellodi management team as it continues to progress APT-1011 through development and towards NDA submission and FDA approval for the treatment of EoE."
“Deb’s deep experience in the pharmaceutical industry coupled with her extensive clinical acumen is an invaluable addition to our team. Her vision, engagement, and leadership have shaped the future of many organizations and I expect she will have the same impact on the development of APT-1011,” said Troy Hamilton, CEO of Ellodi Pharmaceuticals. “As we continue to build Ellodi, we see an opportunity for the company to emerge as a leader in EoE and in the gastroenterology market.”
“We are pleased to welcome Dr. Silberg to Ellodi’s board as we continue to advance the development APT-1011,” said John R. Schilling, MD, Partner at TPG Capital and Chairman of Ellodi Pharmaceuticals. “Dr. Silberg has an established track record of successful GI drug development and FDA approvals, and her partnership, expertise, and guidance will be hugely valuable to our management team.”
Ellodi Pharmaceuticals is now supported by a board of seven executives who have spent their careers in the healthcare sector and bring significant clinical, regulatory, operational, and managerial expertise to the company. The board will continue to provide guidance on the ongoing strategic direction of Ellodi Pharmaceuticals as it works towards the completion and commercialization of the APT-1011 development program.
Additional Information
Dr. Silberg earned her BS degree at the University of Michigan, her PhD in Immunology from Wayne State University School of Medicine, and her MD from Albert Einstein College of Medicine. She completed her Internal Medicine Residency and Gastroenterology Fellowship at the University of Pennsylvania Health System. She then became a faculty member in the Department of Medicine, Division of Gastroenterology at the University of Pennsylvania where she treated patients and was the principal investigator of a National Institutes of Health (NIH) funded molecular biology laboratory. Dr. Silberg has been the recipient of seven NIH grants, published over 40 peer-reviewed articles, served on numerous national scientific committees, is a fellow of the American College of Gastroenterology, and a sought-after lecturer.
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. 2017) 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 or glucocorticoid steroid formulations, and injections of a biologic monoclonal antibody. Despite growing awareness of the condition and its underserved patient population, no orally administered FDA approved treatments are available.
About APT-1011
APT-1011 is a novel, proprietary, once daily, oral disintegrating tablet designed specifically to deliver fluticasone propionate to the esophageal mucosa, exerting broad anti-inflammatory effects via glucocorticoid receptor stimulation locally. The successful completion of FLUTE 1 (Phase 2b study) and FLUTE 2 (Phase 3 study) has facilitated the initiation of FLUTE 3 (ongoing second Phase 3 study - www.ellodipharma.com/flute3study). APT-1011, has received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA), and also received Fast Track Designation from the FDA in 2021. This designation was granted based on data evaluating histological remission and symptomatic improvement after 12 weeks of treatment (induction), and the long-term maintenance of these improvements. More information about APT-1011 can be found at www.ellodipharma.com.
About Ellodi Pharmaceuticals
Ellodi Pharmaceuticals is a gastroenterology-focused specialty pharmaceutical company dedicated to the development of APT-1011, a novel, investigational oral therapy 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.