News

For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.

6th Sep 17

Anti Fibrotic LOXL2 Program Clears Preclinical Development and Set to Commence Phase 1 Trials

Pharmaceutical research company Pharmaxis (ASX: PXS) and its collaborator UK biotechnology company Synairgen plc (AIM: SNG) today announced completion of the preclinical development stage of their anti-fibrotic Lysyl Oxidase type 2 (LOXL2) inhibitor program allowing the first compound to commence human clinical phase I studies in Q4 2017.

The Pharmaxis drug discovery group has developed a number of selective small molecule inhibitors to the LOXL2 enzyme utilising the same amine oxidase platform that delivered PXS-4728A, an anti-inflammatory drug that was acquired by Boehringer Ingelheim in 2015. The LOXL2 enzyme is fundamental to the fibrotic cascade that follows chronic inflammation in the liver disease NASH, cardiac fibrosis, kidney fibrosis, and idiopathic pulmonary fibrosis (IPF), and it also plays a role in some cancers.

Pharmaxis CEO Gary Phillips said, “The extensive pre‐clinical program performed on our program compounds has confirmed that they have all the characteristics of a successful once a day, oral drug. They have shown excellent efficacy in several different in vivo fibrosis models including fibrosis of the liver, lung, kidney and heart. These findings have been the subject of presentations at a number of international scientific conferences and more data will be presented at similar upcoming events as the phase 1 studies proceed. In regulatory toxicity studies, our compounds have been well tolerated and shown a good safety profile.”

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25th Aug 17

Boehringer Ingelheim Initiates Phase IIa Study in NASH

Boehringer Ingelheim initiates Phase IIa study of compound acquired from Pharmaxis in debilitating liver disease NASH

  • Boehringer Ingelheim commences Phase II program of investigational drug candidate BI 1467335 acquired from Pharmaxis with a 12 week Phase IIa proof of clinical principle study in non-alcoholic steatohepatitis (NASH)
  • New study underscores Boehringer Ingelheim’s aspiration to deliver more first in class medicines with breakthrough potential for patients with cardio metabolic diseases
  • Pharmaxis to receive €18 million milestone payment in a significant further endorsement of the company’s ability to generate value from its early stage pipeline.

INGELHEIM, Germany and SYDNEY, Australia – August 24, 2017 – Boehringer Ingelheim and pharmaceutical company Pharmaxis (ASX: PXS) announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, copper containing 3 (AOC3)[1], and works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes underlying NASH.

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18th Aug 17

Pharmaxis Announces Positive Recommendation for Broader Bronchitol Access in Australia

Pharmaceutical research company Pharmaxis (ASX: PXS) today announced it has received a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia for expanded reimbursement of its drug Bronchitol® for the treatment of cystic fibrosis (CF).

The PBAC, the government’s independent advisory body on medicine reimbursement, has cleared the way for Pharmaceutical Benefits Scheme (PBS) funding of Bronchitol in combination with reimbursed Pulmozyme® (another CF medication) after considering a submission from Pharmaxis at its most recent meeting.

Pharmaxis CEO Mr Gary Phillips said, “The submission for broader access to Bronchitol was strongly supported by the cystic fibrosis community with patients, families, patient organisations and CF clinic teams taking part in the feedback process. We look forward to discussing the positive PBAC recommendation with the Australian government to enable the PBS listing that will allow appropriate patients taking Pulmozyme to add reimbursed Bronchitol to their treatment regime.”

Nettie Burke, CEO of Cystic Fibrosis Australia (CFA) said, “Every individual with CF should have access to a variety of treatments which are tailored to their disease and situation. The Bronchitol delivery device is portable, and CFA strongly advocates for better, less burdensome treatments that empower people with CF to lead productive lives. We are pleased that the PBAC has made this recommendation and anticipate an early listing on the PBS.”

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