Genoa Pharmaceuticals and McMaster University demonstrate inhaled pharmacokinetics enables improved pirfenidone activity with significant promise to enhance IPF treatment safety and tolerability

SAN DIEGO, April 21, 2014 /PRNewswire/ -- Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis, and collaborators Drs. Martin Kolb and Kjetil Ask at McMaster University announced today additional measured advantages of inhaled GP-101 (aerosol pirfenidone) in the treatment of idiopathic pulmonary fibrosis (IPF). Our results indicate that very small inhaled doses deliver oral-superior, but short-lived lung levels. To understand if this increased lung dose may improve IPF efficacy, we further demonstrated that only short-lived lung levels are required for maximum pirfenidone activity. Moreover, because these inhaled doses are small, it is anticipated that oral-observed side effects will be substantially reduced. In addition to these observations, characterization of the pirfenidone mechanism suggests that the drug inhibits a single, upstream pro-fibrotic target with strong influence on downstream pathways critical for IPF initiation and disease progression (manuscript in preparation).

"These results further support inhalation as the optimal method to administer pirfenidone to achieve maximum IPF efficacy in a safe and well-tolerated medicine," said Mark Surber, Ph.D., Genoa's President and Chief Executive Officer. "In addition to laying the foundation for successful GP-101 clinical design, these collaborative studies have also expanded our understanding of IPF disease progression and identified a family of additional therapeutic targets."

"Discovery that pirfenidone may inhibit a particular IPF target shown to influence several downstream pathways is important for it may explain some of pirfenidone's effect; showing that inhalation enables improved activity against this important target further justifies this therapeutic approach," said Dr. Martin Kolb, M.D., Ph.D. & Associate Professor in the Division of Respirology, within the Department of Medicine Pathology & Molecular Medicine at McMaster University.  "We are excited to continue our productive collaboration with Genoa, and with these results enter these activities with an increased enthusiasm for GP-101's potential to positively impact the lives of people with this devastating disease."

About Genoa Pharmaceuticals

Genoa Pharmaceuticals, Inc. is committed to developing improved therapies for the treatment of IPF. Based in San Diego, Genoa's lead program, GP-101 (aerosol pirfenidone) is entering clinic-enabling, GLP toxicology for the treatment of IPF. Learn more at www.genoapharma.com

About Dr. Martin Kolb and McMaster University

Dr. Kolb is Associate Professor of Medicine at McMaster University and Research Director of the Firestone Institute for Respiratory Health. Dr. Kolb is a recognized clinician and expert in the field of lung fibrosis whose research activities focus on the biology of lung injury, repair and fibrosis, particularly in Idiopathic Pulmonary Fibrosis (IPF). He has a strong interest in growth factor biology (e.g. TGF-beta and IL-1), extracellular matrix, and mesenchymal cell progenitors (mesenchymal stem cells and fibrocytes). In his lab he uses a variety of disease models to study biological mechanisms and also the efficacy of novel drugs in the preclinical setting. Small animal imaging with CT and PET is one of the exciting new research areas that Dr. Kolb pursues at McMaster in collaboration with other faculty members (Dr. Renee Labiris). Further, Dr. Kolb leads activities in biomarker development for lung fibrosis and he participates as Principal Investigator and Steering Committee members in numerous clinical trials on interstitial lung disease. He was Co-Chair of the Pulmonary Fibrosis Summit in San Diego in December 2013,  and is Chair of the 18^th International Colloquium on Lung Fibrosis in September 2014 (Tremblant, Quebec).

SOURCE Genoa Pharmaceuticals