SOUTHAMPTON, England,
March 10, 2017 /PRNewswire/ --
- Phase I clinical
trial scheduled to start in H2
2017
Synairgen plc (LSE: SNG), the respiratory drug discovery and
development company, today announces further positive data from its
LOXL2 (lysyl oxidase-like 2 enzyme) inhibitor programme against the
lung disease idiopathic pulmonary fibrosis (IPF), being conducted
in collaboration with Pharmaxis (ASX: PXS). Successful completion
of toxicology studies will enable commencement of Phase I clinical
trials in H2 this year as planned.
Using cells from IPF patients, Synairgen has previously reported
that these inhibitors can reduce cross-linking of collagen fibres
in an in vitro model of IPF developed in collaboration with
the University of Southampton and the Company has now demonstrated
that this results in a reduction in tissue stiffness of around 50%.
Today Synairgen also reports that oral administration of one
of these compounds significantly inhibited cross-link formation,
reduced fibrosis score and improved lung function (elastance) in a
preclinical model of lung fibrosis (note 1). Together these results
suggest that inhibition of LOXL2 using these novel inhibitors has
the potential to improve lung function in patients with lung
fibrosis by reducing tissue stiffness.
IPF is a fatal lung disease which, with a median survival of 2
to 3 years[1], carries a worse
prognosis than many cancers. It affects up to 132,000 people in the
US and approximately 50,000 new cases are diagnosed each
year[2]. The current products for
IPF have generated global revenues in excess of $1 billion in
2016[3]. Whilst the underlying
cause of the disease is not fully understood, IPF results from the
relentless build-up of scar tissue which, in turn, damages the
structure of the lung affecting normal uptake of oxygen into the
blood. The resultant stiffening of the lungs makes it
increasingly difficult to breathe. Scar tissue is formed largely of
collagen. LOXL2 is a member of a family of enzymes that stiffen
scar tissue by forming cross-links between the collagen molecules.
Synairgen and Pharmaxis are collaborating to develop small
molecule inhibitors of LOXL2 for the treatment of IPF and other
fibrotic conditions including non-alcoholic steatohepatitis (NASH),
kidney fibrosis and cardiac fibrosis.
Commenting on the results, Richard
Marsden, CEO of Synairgen, said: "The
effect of these inhibitors across different model types
is very exciting, suggesting
that inhibition of LOXL2 has the potential to improve lung
function in severely ill patients with lung fibrosis by reducing
tissue stiffness.
"2017 will be an important year for
Synairgen. Subject to the successful
completion of on-going pre-clinical work, we
expect to commence Phase I clinical trials of the LOXL2
inhibitor during the second half of 2017. The
window for licensing the LOXL2 programme to a
pharmaceutical partner will open at the end of Phase I.
We also expect to hear the outcome of the AstraZeneca Phase II
trial of interferon beta during the first half of
2017."
Note 1: The inhibitor was profiled in a model of progressive
lung fibrosis initiated by local expression of the pro-fibrotic
mediator TGF-β in the lungs using a non-replicating adenoviral
vector. The study was conducted at McMaster
University (Hamilton,
Canada).
References
- Ley B et al. Clinical course and prediction of survival
in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med.
2011 Feb 15;183(4):431-40
- Boehringer Ingelheim - http://www.BreathlessIPF.com. Accessed
9 March 2017.
- Sourced from Roche Finance Report 2016 and Boehringer Ingelheim
press release 3 August 2016.
Notes for Editors
About Synairgen
Synairgen is a respiratory drug discovery and development
company founded by University of Southampton Professors
Stephen Holgate, Donna Davies and Ratko
Djukanovic. The business, focused primarily on asthma and
COPD, uses its differentiating human biology BioBank platform and
world-renowned international academic KOL network to discover and
develop novel therapies for respiratory disease. Leveraging its
scientific and clinical facilities at Southampton General Hospital,
the Company uses in vitro and ex vivo models to
progress opportunities into clinical development. The BioBank of
human samples is used in these models to increase confidence in the
likelihood of successful drug development. Core to Synairgen's
business strategy is the realisation of value via licensing
transactions. This approach has been validated by the licensing
agreement formed with AstraZeneca in June
2014 for Synairgen's SNG001 (AZD9412) programme in
asthma/COPD. In August 2015 the
Company entered into a collaboration with Pharmaxis to develop an
oral LOXL2 inhibitor to reduce fibrosis in patients with idiopathic
pulmonary fibrosis (IPF). Synairgen is quoted on AIM (LSE: SNG).
For more information about Synairgen, please see
http://www.synairgen.com
About Pharmaxis
Pharmaxis is an Australian research pharmaceutical company with
a portfolio of products at various stages of development and
approval. The company's development pipeline is centred on its
expertise in amine oxidase chemistry and includes
Semicarbazide‐Sensitive Amine Oxidase Inhibitors (SSAO) for
Non‐alcoholic Steatohepatitis (NASH) and inflammatory diseases
including Chronic Obstructive Pulmonary Disease (COPD), and Lysyl
Oxidase Inhibitors (LOX) targeting fibrotic diseases including
pulmonary fibrosis and some cancers. Pharmaxis is listed on the
Australian Securities Exchange (symbol PXS). For more
information about Pharmaxis, please see
http://www.pharmaxis.com.au.
For further information, please contact:
Synairgen plc
Tel: +44(0)23-8051-2800
Richard Marsden, Chief Executive
Officer
John Ward, Finance Director
FinnCap (NOMAD)
Geoff Nash, James Thompson (Corporate Finance)
Stephen Norcross, Simon Johnson (Corporate Broking)
Tel: +44(0)20-7220-0500
Consilium Strategic Communications (Financial Media and Investor
Relations)
Mary-Jane Elliott / Sue Stuart / Jessica
Hodgson / Laura Thornton
synairgen@consilium-comms.com
Tel: +44(0)20-3709-5701