LONDON, October 11, 2018 /PRNewswire/ --
Arix Bioscience plc ("Arix") (LSE:
ARIX), a global healthcare and life science company supporting
medical innovation, is pleased to note that its Group Business,
Pharmaxis Ltd (ASX: PXS), an Australian pharmaceutical research
company focused on inflammation and fibrosis, today announced
positive results from the Phase 1 clinical trial for the first of
its Lysyl Oxidase Like 2 (LOXL2) inhibitor compounds being
developed to treat fibrotic diseases such as Non‐Alcoholic
Steatohepatitis (NASH) and Idiopathic Pulmonary Fibrosis (IPF).
The announcement can be accessed on Pharmaxis' website at
http://www.pharmaxis.com.au/investor-centre/news/ and full text of
the announcement from Pharmaxis is contained below.
Enquiries
For more information on Arix, please contact:
Arix Bioscience plc
Charlotte Parry, Head of Investor
Relations
+44(0)20-7290-1072
charlotte@arixbioscience.com
Optimum Strategic Communications
Mary Clark, Supriya Mathur
+44(0)203-714-1787
optimum.arix@optimumcomms.com
Burns McClellan (US Media & IR Enquiries)
Lisa Burns, Nancie Steinberg
+1-212-213-0006
arix@burnsmc.com
About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science
company supporting medical innovation. Headquartered in
London and with an office in
New York, Arix Bioscience sources,
finances and builds world class healthcare and life science
businesses addressing medical innovation at all stages of
development. Operations are supported by privileged access to
breakthrough academic science and strategic relationships with
leading research accelerators and global pharmaceutical
companies.
Arix Bioscience plc is listed on the Main Market of the London
Stock Exchange. For further information, please visit
http://www.arixbioscience.com
Media Release
11 October 2018
PHARMAXIS RELEASES POSITIVE RESULTS
OF PHASE 1 CLINICAL TRIAL FOR LOXL2 INHIBITOR
COMPOUND
Pharmaceutical company Pharmaxis (ASX: PXS) today announced
positive results from the Phase 1 clinical trial for the first of
its Lysyl Oxidase Like 2 (LOXL2) inhibitor compounds being
developed to treat fibrotic diseases such as Non‐Alcoholic
Steatohepatitis (NASH) and Idiopathic Pulmonary Fibrosis (IPF).
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 10mg to 400mg 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 100mg to 400mg or placebo for 14 days.
The excellent drug like properties demonstrated in earlier
pre‐clinical testing were confirmed. There were no adverse safety
findings in either the first or second stages of the study and the
pharmacokinetic profile showed the expected dose related increases
in exposure.
In addition to studying the safety and pharmacokinetic profile,
the clinical trial also 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 and
that daily dosing over a 14‐day period now meets our targeted
effect of greater than 80% inhibition at the 400mg dose.
Pharmaxis 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."
The Phase 1 trial for a second Pharmaxis LOXL2 compound being
studied has recently completed dosing and will report in the
current quarter.
The company's LOXL2 program compounds are highly selective small
molecule inhibitors of LOXL2 that can be administered orally. The
ongoing pre‐clinical development program supports the potential of
both compounds to treat fibrotic disease in several organs. This
support has been enhanced by recent breakthroughs in Pharmaxis
proprietary assay technology that have demonstrated target
engagement in animal tissue from the pre‐clinical studies as well
as serum. 28‐day animal toxicity studies have been completed in two
species for both compounds and the remaining 3 month studies are
due to be completed later this quarter.
Pharmaxis has previously announced its intention to partner the
LOXL2 program after phase 1 studies are complete. Mr Phillips said,
"We believe that the best in class LOXL2 inhibition and the
availability of two compounds with differentiated pharmacokinetic
profiles make this program very attractive and 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.
SOURCE: Pharmaxis Ltd, Sydney,
Australia
CONTACT: Felicity Moffatt, phone
+61-418-677-701 or email felicity.moffatt@pharmaxis.com.au
About Pharmaxis
Pharmaxis (ACN 082 811 630) is an Australian pharmaceutical
research company focused on inflammation and fibrosis with a
portfolio of products at various stages of development and
approval. Its product Bronchitol® for cystic fibrosis is marketed
in Europe, Russia and Australia. Its product Aridol® for the
assessment of asthma is sold in Europe, Australia and Asia. The company's development pipeline is
centred on its expertise in amine oxidase chemistry and includes a
series of Lysyl Oxidase Inhibitors under clinical development
targeting fibrotic diseases of the heart, kidney, liver and lung.
In May 2015, Boehringer Ingelheim
acquired the Pharmaxis investigational drug PXS‐ 4728A, a potent
inhibitor of Semicarbazide‐Sensitive Amine Oxidase (SSAO), to
develop it for the treatment of the liver‐related condition
Non‐alcoholic Steatohepatitis (NASH) and other inflammatory
diseases. Pharmaxis is listed on the Australian Securities Exchange
(symbol PXS). The company's head office, manufacturing and research
facilities are located in Sydney,
Australia. For more information about Pharmaxis, please see
http://www.pharmaxis.com.au
Forward‐Looking Statements
Forward‐looking statements in this media release include
statements regarding our expectations, beliefs, hopes, goals,
intentions, initiatives or strategies, including statements
regarding the potential of products and drug candidates. All
forward‐looking statements included in this media release are based
upon information available to us as of the date hereof. Actual
results, performance or achievements could be significantly
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and involve known and unknown risks, uncertainties and other
factors, many of which are beyond our control, and which may cause
actual results to differ materially from those expressed in the
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undertake no obligation to update these forward‐looking statements
as a result of new information, future events or otherwise.