Genoa Pharmaceuticals and McMaster University Demonstrate Inhaled Pharmacokinetics Enables Improved Pirfenidone Activity With Significant Promise to Enhance IPF Treatment Safety and Tolerability

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San Diego, CA – June 5, 2013 – Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis and collaborator’s Drs. Martin Kolb and Kjetil Ask at McMaster University announced today the measured advantages of inhaled GP-101 (aerosol pirfenidone) in the treatment of pulmonary fibrosis. Utilizing the standard in vivo model of bleomycin-induced pulmonary fibrosis, we have demonstrated that small inhaled doses yielding high peak, short duration lung pirfenidone concentrations offers statistically greater anti-fibrotic efficacy than higher oral doses resulting in low peak drug exposure. As these small inhaled doses also largely avoid the gastrointestinal tract, inhalation holds promise to reduce or eliminate gastrointestinal and systemic side effects observed with the oral medicine. The company expects to present these findings at an upcoming pulmonary fibrosis meeting.

“Genoa is very excited about these findings and the potential for inhaled GP-101 to benefit IPF patients”, said Mark Surber, Ph.D., Genoa’s Founder, President and Chief Scientific Officer. “For IPF treatment to be successful, sufficient drug must first be delivered to the lung. Although the oral dose size is large, because swallowed pirfenidone spreads throughout the body before reaching the lung the resulting delivered lung dose is quite small. As inhalation delivery administers pirfenidone directly to the lung, a significant increase is achieved with only a very small inhaled dose. By this route of administration, it is further anticipated that patient compliance will also improve.”

“The efficacy of inhaled pirfenidone on improving outcomes in the animal model is quite remarkable”, 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 observed stronger anti-fibrotic effects than with oral pirfenidone, notably at an equivalent tissue level, suggesting the compound reaches important tissue compartments better if administered by inhalation. Considering the resultant systemic dose was just a fraction of that seen following oral delivery, one would expect fewer adverse effects with inhaled GP-101, which would most likely improve patient compliance. This result certainly warrants further clinical evaluation of inhaled GP-101 in IPF patients.”

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) plans to enter clinical trials in early 2015.

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 18th International Colloquium on Lung Fibrosis in September 2014 (Tremblant, Quebec).