Eurand, a specialty pharmaceutical company, today announced the initiation of the second of two Phase III clinical trials required for registration of its Pancreatic Enzyme Product (PEP), EUR-1008, in patients with Exocrine Pancreatic Insufficiency (EPI). EPI is a deficiency of digestive enzymes normally produced by the pancreas which leads to malnutrition, impaired growth and shortened life expectancy. EPI can result from a number of diseases and conditions, including Cystic Fibrosis (CF), chronic pancreatitis and pancreatic cancer.
The trial is designed to determine the safety and tolerability of EUR-1008 in children under the age of seven. The trial will involve approximately ten clinical study sites in the United States. Patient enrolment has commenced and is expected to be complete by end of the third quarter 2006. Results of the study are expected in the fourth quarter of 2006. The protocol for the trial has been prepared in collaboration with the Cystic Fibrosis Foundation Therapeutic Development Network.
EUR-1008 is a new and proprietary PEP developed by Eurand. It has been developed as a delayed-release capsule intended to provide consistent product dosing over time, and EUR-1008 will be available in multiple dosage strengths to provide flexibility and convenience in dosing. A low dose, micro-tablet formulation has been specifically developed for young children.
Dr. Jamie Wooldridge MD, Assistant Professor of Pulmonary Medicine at Children’s Hospital Medical Center, Cincinnati, Ohio and Lead Investigator for the trial commented: “The correct treatment of pancreatic insufficiency is fundamental to the management of cystic fibrosis in young children, this pediatric trial will further evolve our understanding of the disease and how best to treat our patients.”
TRIAL DESIGN AND ENDPOINTS
The Phase III trial will be conducted in CF care centers in the United States. The study will be a multi-center, open label trial in patients under seven years of age with pancreatic insufficiency and cystic fibrosis. The study will evaluate the safety and efficacy of EUR-1008 in improving fat absorption, while assessing among other endpoints, improvements in protein and other nutrient absorption.
EUR-1008 is a new orally delivered pancreatic enzyme product consisting of approximately 14 enzymes, coenzymes and cofactors. It is biologically similar to endogenous human pancreatic secretions and is intended to treat malabsorption of fats, proteins, carbohydrates and other essential nutrients in patients with pancreatic insufficiency. EUR-1008 is a highly stable formulation that has been developed to meet the US Food and Drug Administration (FDA) guidelines for pancreatic enzyme products. EUR-1008 is being developed in a number of dosage forms and strengths that Eurand believes will provide consistent product dosing, stability, long-term shelf life and convenient dosing.
Current treatment of pancreatic insufficiency requires the use of pancreatic enzyme products. None of the currently marketed products in the United States have been approved by the US Food and Drug Administration. The FDA has issued regulations requiring all PEPs marketed after April 2008 to have an FDA approved registration. Eurand is conducting two phase III trials in support of registering EUR-1008 for the treatment of exocrine pancreatic insufficiency.
“With our first EPI trial up and running, we are delighted to announce the commencement of patient recruitment for this our second trial,” commented Gearoid Faherty, CEO of Eurand. “We believe that this trial, in which all of the patients will be less than seven years old, will be the first such trial of this design to be conducted in the United States in over 15 years. As children represent a significant part of the EPI patient population, it is vital that we understand how these drugs perform in this patient group.”