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Anti Fibrotic LOXL2 Program Set To Commence Phase 1 Trials in Q4 2017

Pharmaxis has consolidated its position as a significant competitor in the NASH market as the LOXL2 inhibitor joins its SSAO inhibitor in the clinic. Pharmaxis and its collaborator UK biotechnology company Synairgen plc recently 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.

The extensive pre‐clinical program performed on the program compounds confirmed that they have all the characteristics of a successful once a day, oral drug showing excellent efficacy in several different in vivo fibrosis models including fibrosis of the liver, lung, kidney and heart. In regulatory toxicity studies, our compounds have been well tolerated and shown a good safety profile.

NASH is a growing and valuable market for the future and we anticipate that our LOXL2 program will be attractive to many of the multinational pharmaceutical companies that are building a portfolio approach to treating NASH and some other fibrotic diseases such as IPF.

Watch a video of Gary Phillips discussing LOXL2 program

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Boehringer Initiates a Phase 2a Study in Second Disease Indication for Drug Acquired from Pharmaxis in 2015

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Boehringer Ingelheim and Pharmaxis have announced that Boehringer Ingelheim is initiating a Phase 2a study in diabetic retinopathy (DR) using orally administered BI 1467335 - a Pharmaxis drug discovery formerly known as PXS-4728A.

This new study is in addition to a phase 2a clinical trial commenced in the liver-related disease NASH in August 2017 - the start of which triggered a payment of a development milestone to Pharmaxis of approximately A$27 million.

Key points about the second study:

  • DR is the leading cause of vision-loss in adults aged 20-74.
  • Diabetic retinopathy is the second severe metabolic complication on top of non-alcoholic steatohepatitis (NASH) to be investigated for BI 1467335, which was acquired from Pharmaxis
  • Pharmaxis will receive €10 million milestone payment when the first patient is dosed in this 2nd indication Phase IIa study.
  • Boehringer Ingelheim’s holistic cardio metabolism R&D strategy reaches from risk factors, like obesity to complications, like NASH and DR  

Details of the DR clinical trial can be found here.

Watch a 5 minute video with Pharmaxis CEO Gary Phillips discussing the clinical program with Boehringer: https://www.youtube.com/watch?v=OSB0fGkW5Kk

Find out more about the sale to Boehringer

Find out more about the commencement of the phase 2 study in NASH

Pictured above : Pharmaxis CEO Gary Phillips and Boehringer Ingelheim MD Australia & NZ Wes Cook mark the start of a new clinical tril in diabetic retinopathy.

 

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Chairman Malcolm McComas’ Address to the 2017 Pharmaxis Annual General Meeting

 

Welcome to the Pharmaxis 2017 Annual General Meeting, a meeting that follows another successful year for the Company in terms of revenue, drug development initiatives and shareholder value.

On 22 September 2017, something we had pointed to for some time happened as expected. It was however something that is not common in the pharmaceutical research sector.  Without going out to the stock market and asking shareholders for new money, Pharmaxis banked $27m cash.   This was the second payment received from Boehringer Ingelheim and together with their initial $41m payment received in May 2015, total cash received to date is $68m.  This is equivalent to approximately 21 cents per share.

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