Pharmaxis inflammatory disease drug enters phase I

Pharmaxis (ASX:PXS) has commenced a phase I trial of its inflammatory disease treatment candidate PXS4728A.

PX4728 is a semicarbazide-sensitive amine oxidase (SSAO) inhibitor that can be administered orally and has shown drug-like properties in preclinical development.

The phase I single ascending dose study will be conducted in 48 Australian subjects. If results are positive, the company plans to proceed with a multiple ascending dose study in 24 subjects.

The trial is expected to report in the third quarter of 2015 and cost around $2 million.

The SSAO enzyme plays a role in a variety of inflammatory diseases, particularly liver diseases including non-alcoholic steatohepatitis (NASH), a condition with a high unmet clinical need.

Pharmaxis CEO Gary Phillips said the company has been investing in its early-stage pipeline as part of its plan to refocus the business.

“PXS4728A is the first candidate from our amine oxidase research platform to have passed all its preclinical tests and be cleared to progress to human trials,” he said.

“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 we believe will enhance the company’s partnering negotiations which are continuing to progress to plan.”

Fellow Australian biotechnology company Immuron is developing IMM-124E as a potential NASH treatment and plans to commence recruitment for a clinical trial in the indication shortly.

Pharmaxis (ASX:PXS) shares were trading 12% lower at $0.11 as of around 2 pm on Wednesday