Pharmaxis Announces Commencement of Phase 1 Clinical Trial for Novel SSAO / VAP-1 Inhibitor
Release Date: 21/01/2015 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced that it has commenced a Phase 1 clinical trial of its Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor (PXS4728A) investigating its potential to treat inflammatory diseases.
PXS4728 is a highly selective small molecule inhibitor of SSAO that can be administered orally and has already demonstrated acceptable drug like properties during pre-clinical development.
The initial stage of the trial is a single ascending dose study being conducted in 48 subjects at an Australian Phase 1 clinical trial centre. If these results are positive, the Company will proceed to a multiple ascending dose study in 24 subjects. The trial is expected to report in the third quarter of 2015 and cost approximately $2 million.
The SSAO enzyme has emerged as a target of interest for various inflammatory diseases during the last 12 months and a recent peer reviewed publication validated its particular importance in liver diseases such as Non-Alcoholic Steatohepatitis (NASH). The NASH market is an area of high unmet clinical need and has been estimated by industry analysts to reach approximately $1.6 billion by 2020 with a number of companies engaged in active research and clinical development. The high prevalence of type 2 diabetes and obesity, which lead to NASH and other non-alcoholic fatty liver diseases, is expected to boost market growth.
Pharmaxis CEO Mr Gary Phillips said, “The Company has been investing carefully in its early stage pipeline over the past two years as part of its plan to refocus the Pharmaxis business. PXS4728A is the first drug candidate from our amine oxidase research platform to have passed all its pre-clinical tests and be cleared to progress to human trials. Having successfully completed the partnering of Bronchitol for the US late last year, it is now appropriate to make a further investment in the SSAO program, an investment that we believe will enhance the Company’s partnering negotiations which are continuing to progress to plan.”
Categories: News and Media