Lab for Home 1

Pipeline Opportunities in the Clinic for Fibrosis and Inflammation

Pan-LOX inhibitor PXS-5505

  • Targeting liver and pancreatic cancer
  • Status: protocol and funding discussions with independent investigators
  • More information here

LOXL2 inhibitor PXS-5382

  • Anti fibrotic targeting chronic kidney disease (CKD), pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH)
  • Status: Partnering discussions for phase 2 commencement
  • More information here

Topical pan-LOX inhibitor PXS-6302

  • Anti scarring: burns, established scars
  • Status: Phase 1 Investigator Initiated Studies (IIS) commencing Q1 2021; IIS patient studies in burns and established scars H2 2021
  • More information here

SSAO inhibitor PXS-4728

  • Anti inflammatory: neuro inflammation
  • Status: Evaluate Boehringer data package and the opportunity to repurpose
  • More information here
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Pharmaxis Targets Myelofibrosis in New Clinical Trial

Pharmaxis is advancing a 6-month Phase 2 clinical trial of a new drug (PXS-5505) targeting the rare bone cancer myelofibrosis (MF).

PXS-5505 is an anti‐fibrotic pan-Lysyl Oxidase (pan-LOX) inhibitor that has completed long-term toxicity studies and Phase 1a and 1b clinical trials demonstrating a well-tolerated drug that effectively inhibits all enzymes in the lysyl oxidase family that are involved in fibrosis.

Myelofibrosis is a cancer with a poor prognosis and limited therapeutic options. Pharmaxis believes that the current treatments can be augmented by use of a pan-LOX inhibitor and be disease modifying in a market that is conservatively worth US$1 billion per annum.

PXS-5505 was granted Orphan Drug Designation by the US Food and Drug Administration (FDA) in July 2020. Read the media release.

In August 2020 the FDA completed a review of the company’s Investigational New Drug (IND) application for PXS-5505 and gave Pharmaxis the green light to proceed with a phase 1c/2a clinical trial for the treatment of myelofibrosis in adults.  The clinical trial protocol incorporates a one-month dose escalation phase followed by six months’ treatment in an open label study of patients who are not on a JAK inhibitor. The company is well advanced in its preparations to start this study and expects patient recruitment in Q1 2021. The study is expected to conclude in 2022. Read the media release.

Gary Phillips CEO Pharmaxis

Recent News

Pharmaxis Receives US$7m Milestone from Chiesi following FDA Approval of Bronchitol.

Read the media release here.

FDA Approves Bronchitol for US Market

Pharmaxis Ltd announces the United States Food and Drug Administration (FDA) has approved Bronchitol® (mannitol) as add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older. The product, developed by Pharmaxis in Australia, has been steered through final stages of FDA approval by US licensee Chiesi Farmaceutici SpA (Chiesi).

Following a US$7 million milestone received from Chiesi in December 2020, a further US$3 million is payable on shipment by Pharmaxis of commercial launch stock of Bronchitol scheduled for the first quarter of 2021.

Read the media release here

Current Investor Presentation  - view here

Recent interviews with CEO Gary Phillips: 

Pharmaxis Investment Summary available here