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Phase I drug demonstrates oral bioavailability, target inhibition, safety and tolerability
May 18, 2015
By: Kristin Brooks
Boehringer Ingelheim has exercised the option under its Pharmaxis alliance to acquire the investigational drug PXS4728A for the treatment of the liver-related condition NASH. PXS4728A is a Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor that works as an anti-inflammatory, and in Phase I studies, demonstrated oral bioavailability, long-lasting target inhibition and good safety and tolerability. Pharmaxis will receive $39 million upfront and is eligible for development and commercialization milestones. Boehringer will be responsible for all development, regulatory, manufacturing and commercialization activities. Boehringer has also acquired other SSAO/VAP-1 inhibitor molecules related to PXS4728A and associated patents. NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), the most common liver disorder in Western industrialized nations, and is a major cause of fibrosis and cirrhosis of the liver. Type 2 diabetes and obesity can also lead to NASH. It’s currently an area of high unmet clinical need. Pharmaxis chief executive officer Gary Phillips said, “This is a transformational event for Pharmaxis. With a total potential value in excess of $750 million, it is a globally competitive deal and significant for the Australian biotech sector. Boehringer Ingelheim’s clinical expertise will now be applied to the development of this drug which has the potential to make a real difference in the treatment of diseases with high unmet clinical need.” Glyn Parkin, senior vice president and Metabolism head at Boehringer Ingelheim said, “We have ambitious strategic goals in diabetes and metabolism and this Phase I asset acquisition fits well into our development portfolio. We are pleased to have achieved access to Pharmaxis’ research excellence and innovative approach to treatments for NASH.”
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