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Pharmaxis receives positive results from LOXL2 clinical trial

There were no adverse safety findings and excellent drug-like properties were confirmed.
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Interest is increasing from major pharmaceutical companies looking to acquire

Pharmaxis Ltd (ASX:PXS) has received positive results from the phase I clinical trial for the first of its LOXL2 inhibitor compounds being developed to treat fibrotic diseases.

These include the liver disease known as non‐alcoholic steatohepatitis (NASH) and the lung disease idiopathic pulmonary fibrosis (IPF).

Importantly, there were no adverse safety findings in the study and the pharmacokinetic profile showed the expected dose-related increases in exposure.

READ: Pharmaxis adds valuable experience with Ed Rayner appointment

Pharmaxis’s CEO Gary Phillips said: “I’m delighted that the excellent pharmacokinetic parameters and the significant and long-lasting inhibition of the target LOXL2 enzyme demonstrated in the single dose stage of the study earlier this year completely translated into the profile we have seen in the multiple dosing study.

“This drug profile has led to increased interest from major pharmaceutical companies looking for good anti-fibrotic programs to acquire. 

“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.” 

Two-stage study

The double‐blind placebo-controlled study consisted of two stages.

The first single ascending dose stage was conducted in 48 healthy subjects divided into six groups with each taking a single dose ranging from 10-400 milligrams or placebo.

The second multiple ascending dose stage was conducted in 24 healthy subjects divided into three groups which each received a single daily dose ranging from 100-400 milligrams or placebo for 14 days.

Early signs show drug inhibits target enzyme

The clinical trial investigated the degree to which the drug can inhibit the target enzyme LOXL2, which is implicated in several different fibrotic diseases.

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

Furthermore. daily dosing over a 14‐day period met Pharmaxis’s targeted effect of greater than 80% inhibition at the 400-milligram dose.

Intention to partner the LOXL2 program after phase I

Phillips added: “We believe that the best in class LOXL2 inhibition and the availability of two compounds with differentiated pharmacokinetic profiles make this program very attractive.

“We look forward to concluding a licensing deal with a partner committed to develop the compounds in indications where there remain a lack of treatment options and significant commercial opportunities.”

Additionally, the phase I trial for a second LOXL2 compound being studied has recently completed dosing and will report in the current quarter.

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