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Pharmaxis phase I trial attracts interest from multiple pharmaceutical companies

Final stages of phase I studies and phase II enabling toxicity studies are due to complete in Q3 2018.
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Initial results from phase I demonstrate best in class profile for LOXL2

Pharmaxis Ltd (ASX:PXS) has briefed potential partners attending the BIO18 partnering conference in Boston on data emerging from the phase I clinical studies of its anti‐fibrotic LOXL2 inhibitor program in which two compounds are showing significant inhibition of the enzyme for 24 hours with a single oral dose.  

LOXL2 or lysyl oxidase like 2 has been implicated as a key factor in various fibrotic diseases in organs such as the liver, lung, heart and kidney.

WATCH: Pharmaxis has the "secret sauce" for developing drugs through to commercialisation

Pharmaxis’ two compounds have both cleared the first stage of the studies where single oral doses of different strengths were trialled in healthy volunteers. 

There were no adverse safety findings in this first stage.   Both drugs are now entering the final stage where different fixed doses are given for 14 days.

In addition to studying their safety and pharmacokinetic profiles the two studies are also investigating the degree to which these drugs can inhibit the target enzyme LOXL2.

Importantly, Pharmaxis has been able to demonstrate a large and highly significant inhibition of this enzyme for a full 24 hours with a single oral dose.

Pharmaxis chief executive officer Gary Phillips said: “The data package being reviewed by several multinational pharmaceutical companies under confidentiality agreements is now maturing rapidly as we see the final data being generated by ongoing pre‐clinical and clinical studies. 

“There are a number of key features which have contributed to an increase in the already strong interest amongst these companies.”

The amine oxidase platform at Pharmaxis has generated small molecule enzyme inhibitors to a range of important disease targets that are at various stages of development. 

The SSAO inhibitor acquired by Boehringer is in phase II and the LOXL2 inhibitors are in phase I trials.

Meanwhile a compound inhibiting both myeloperoxidase (MPO) and SSAO and another compound inhibiting all the LOX family of enzymes are both in the final stages of pre‐clinical testing with phase I trials scheduled to commence in the next 6 to 12 months.

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