Pharmaxis gets another fatty liver drug through clinical trials; shares gain
Another of ‘fatty liver’ drug maker Pharmaxis’s drugs has made it through a clinical trial — this time a compound that might also help with scarred lungs.
The shares rose 7 per cent to 31c in early Thursday trade.
Pharmaxis (ASX:PXS) says a phase one clinical trial for the first of its Lysyl Oxidase Like 2 (LOXL2) inhibitor compounds shows it’s safe for human use.
Clinical trials are generally divided into three phases. phase one focuses on safety, phase two tests for effectiveness and phase three examines whether the new drug is an improvement on existing treatment.
LOXL2 is an enzyme that stiffens scar tissue. A build up of scar tissue or too much inflammation can lead to fibrosis, a nasty problem in a place like the lungs or liver because it makes it difficult for them to work properly.
The compound is being tested to inhibit, or prevent, excessive stiffening of scar tissue. In the lungs this is called Idiopathic Pulmonary Fibrosis (IPF), a disease with a two to three year survival rate.
In the liver Pharmaxis is testing the enzyme on ‘non-alcoholic steatohepatitis’, or fatty liver, a condition appears when the liver becomes inflamed and damaged due to a build-up of fat.
The double-blind trial consisted of 48 healthy people taking a single dose of between 10mg and 400mg or a placebo, and another group of 24 healthy people taking multiple doses of 100mg to 400mg over two weeks.
Pharmaxis CFO David McGarvey says the trial did two things: it showed the dosage was safe and it “engaged with the target” — find the LOXL2 enzyme.
The second part of the trial with the group of 24 showed the drug stayed in the blood and had a cumulative effect after a couple of days, which Mr McGarvey says is what you want from a drug.
He told Stockhead that healthy people do not have high levels of LOXL2 in their bodies, but they developed a proprietary way to test it nonetheless and can go into Phase 2 trials knowing already that the compound can actually find the enzyme it’s supposed to inhibit.
Pharmaxis CEO Gary Phillips says they plan to find a partner to further develop the program after Phase 1 studies of other LOXL2 compounds are done.
“Today’s announcement that enzyme inhibition is further enhanced after daily dosing over 14 days goes a long way to completing the data package on which we will base continuing scientific and commercial discussions with potential partners during the current quarter,” he said.
He says they plan to find a partner to further develop the program after Phase 1 studies of other LOXL2 compounds are done.
Pharmaxis has already found a partner for another fatty liver drug.
German pharma giant Boehringer Ingelheim is testing Pharmaxis’s BI 1467335 diabetes eye drug and paid a $15m milestone fee in January for the pleasure.
That drug is also being tested on fatty liver disease via a Phase 2a clinical trial.
Boehringer Ingelheim bought that drug in 2015 — with an upfront payment of $41m — to study it for the liver condition.