Ligand Pharmaceuticals Incorporated announced that Eli Lilly and Company has made the decision to advance LY519818 into Phase 3 registration studies. LY519818 is a novel, potent, oral, once-daily peroxisome proliferator-activated receptor (PPAR) modulator for the treatment of type 2 diabetes. Initiation of the Phase 3 program will follow appropriate consultation with the FDA. LY519818 was discovered through the ongoing research collaboration between Lilly and Ligand.
PPARs are a sub-family of intracellular receptors that regulate glucose and lipid homeostasis. They play a key role in enhancing cellular responses to insulin, and in fat tissue stores and metabolism. Efficacy and safety data from a recently completed blinded, randomized, multi-dose comparator Phase 2 study are expected to be presented at a major scientific meeting this year.
"Lilly's decision to move LY519818, the first of a series of distinct PPAR modulators, into Phase 3 studies is an important milestone toward commercializing products with enhanced activity and broader therapeutic profiles for the treatment of type 2 diabetes," said Andres Negro-Vilar, Ligand's executive vice president for research and development and chief scientific officer. "Lilly's decision further underscores the productivity of our joint research collaboration and the extraordinary progress we have made together in the field. We have developed a broad platform of compounds with distinct receptor specificity and tissue selectivity for the treatment of diabetes, dyslipidemias, and associated cardiovascular disorders."
The Lilly-Ligand collaboration, which began in 1997, has advanced two other PPAR modulators into clinical studies. LY929, for the treatment of type 2 diabetes, metabolic diseases and dyslipidemias, entered clinical development in mid-2002. LY674, for the treatment of dylipidemias, entered clinical development in late 2002. Lilly and Ligand also maintain an active preclinical development program, and plan to advance additional product(s) into clinical studies during the course of 2004.
Under the terms of the collaboration, Ligand receives research funding from Lilly. Lilly is responsible for the development and registration of any products resulting from the collaboration, and pays Ligand milestone payments as products move through the development process. Lilly has exclusive worldwide marketing rights to products resulting from the research, and will pay Ligand royalties on sales of products that make it to market. If LY519818 is successfully developed and marketed, Ligand will receive additional milestone payments, including a milestone on initiation of Phase 3 studies, plus royalties on net sales of up to low double digits.