The overall objective of this program is to commercially develop a significantly improved high potency dosage form of a novel digestive adjuvant. The target pharmaceutical is a stable polymer-coated (p.c.) digestive enzyme/bile acid-containing microsphere (DIGESTIZYME) for pancreatic enzyme-deficient cystic fibrosis (C.F.) patients that is superior to the currently marketed digestive enzyme products. The objectives of this Phase II proposal are to continue product development, select the final formula, scale-up a process for the production of a clinical batch under Good Manufacturing Practices (GMP), characterize the clinical batch and initiate long-term stability testing, establish product safety in animals, and file an Investigational New Drug Application (INDA) with the U.S. Food and Drug Administration (FDA) for the conduct of human Phase I and II clinical studies. The human clinical studies are projected to be conducted as part of the Phase III program.
