Synairgen plc AZD9412 Update (4767D)
27 April 2017 - 4:02PM
UK Regulatory
TIDMSNG
RNS Number : 4767D
Synairgen plc
27 April 2017
Press release
Synairgen plc
('Synairgen' or the 'Company')
AZD9412 Update
-- Cold infections did not affect trial patients' asthma in the
INEXAS study as much as predicted, meaning that the drug's effects
on severe exacerbations could not be determined
-- Treatment with AZD9412 switched on antiviral responses in the
lungs, improved morning peak flow (a measure of lung function), and
was well tolerated
-- The study however, did not meet AstraZeneca's predefined
criteria for progression, and they have elected to return the
rights to AZD9412 to Synairgen
-- Synairgen will conduct further analysis of the data and determine future development routes
Southampton, UK - 27(th) April 2017: Synairgen plc (LSE: SNG),
the respiratory drug discovery and development company, today
provides an update on AZD9412 (inhaled interferon beta).
In October 2016 Synairgen provided the market with an update on
the INEXAS trial of AZD9412, a novel, inhaled interferon beta that
supports the immune system by correcting a deficiency which makes
patients vulnerable to respiratory tract viral infections
(primarily common cold viruses). The trial was stopped early due to
a low severe exacerbation event rate which compromised an
assessment of this endpoint (number of severe exacerbations).
Treatment with inhaled interferon beta did however switch on the
lungs' antiviral defences (as measured by blood levels of the
antiviral biomarker CXCL10), have a beneficial effect on lung
function (Morning Peak Expiratory Flow: difference of 19.7 litres
per minute average over the first 7 days of treatment (p=0.01)),
and was well tolerated. Effects on biomarkers, lung function and
the good tolerability profile were consistent with the Company's
own Phase II trial (SG005).
The study did not however meet AstraZeneca's predefined criteria
for progression, and they have elected to return the rights to
AZD9412 to Synairgen.
Further analysis of samples from the trial is being completed by
AstraZeneca. Data from this sample analysis and the clinical trial
data will be licensed to Synairgen. Synairgen will complete the
data analysis and will use this as a basis to determine the future
direction of the programme.
Professor Stephen Holgate CBE, Medical Research Council Clinical
Professor of Immunopharmacology at the University of Southampton,
said: "We believe that the biomarker, lung function and safety data
from this and our previous study continue to support the potential
of inhaled interferon beta as a treatment for vulnerable patients
whose disease control is badly affected when they get a cold. We
are particularly interested in the potential for COPD, where
exacerbations are associated with disease progression and an
increased risk of dying. Since we licensed this programme to
AstraZeneca, the weight of data linking viruses to COPD
exacerbations has increased, and the link of colds to secondary
bacterial infections has become widely accepted."
Richard Marsden, CEO of Synairgen, said: "We remain positive
about the potential of inhaled interferon beta, particularly for
patients with COPD who suffer due to respiratory viruses. Once we
have completed the data analysis, we will provide an update on the
programme and our plans for future development."
The information communicated in this announcement contains
inside information for the purposes of Article 7 of the Market
Abuse Regulation (EU) No. 596/2014.
-Ends-
For further information, please contact:
Synairgen plc Tel: +44 (0) 23 8051 2800
Richard Marsden, Chief Executive Officer
John Ward, Finance Director
FinnCap (NOMAD) Tel: +44 (0) 20 7220 0500
Geoff Nash, James Thompson (Corporate Finance)
Stephen Norcross, Simon Johnson (Corporate Broking)
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
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. 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 www.synairgen.com
About the INEXAS trial:
In the trial, named INEXAS (details available on
www.clinicaltrials.gov), asthma patients were dosed with placebo or
AZD9412 at the onset of common cold symptoms. Previous research had
shown that common colds can cause severe exacerbations of asthma
and that boosting the antiviral defences of the lung with AZD9412
(inhaled interferon beta, and antiviral protein) during this time
could prevent exacerbations from developing.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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