Synairgen plc AZD9412 Clinical Trial Update (2831M)
October 12 2016 - 2:00AM
UK Regulatory
TIDMSNG
RNS Number : 2831M
Synairgen plc
12 October 2016
Press release
Synairgen plc
('Synairgen' or the 'Company')
AZD9412 Clinical Trial Update
AstraZeneca to focus on key secondary endpoints with results
expected in Q1 2017
Southampton, UK - 12 October 2016: Synairgen plc (LSE: SNG), the
respiratory drug discovery and development company, announced today
that it has received the following INEXAS clinical trial update
from AstraZeneca (AZ) relating to AZD9412, inhaled interferon beta,
a programme developed by Synairgen and licensed to AZ in June
2014.
INEXAS clinical trial update from AstraZeneca:
"AstraZeneca has decided to stop the Phase IIa trial for AZD9412
based on an interim analysis, where an overall very low number of
reported severe exacerbations could make primary endpoint
conclusions difficult.
"The interim analysis confirmed the positive safety and
tolerability profile seen in previous trials, and inhaled IFN-b
remains an interesting treatment opportunity for patients with
respiratory disease. AstraZeneca will now review the data and study
design before deciding on the best way forward for the
programme."
AstraZeneca will evaluate the key data collected from the INEXAS
trial with a focus on the secondary endpoints that are most
predictive of disease worsening to exacerbation, and Synairgen has
been informed that there will be sufficient numbers of patients in
the trial to assess this. Full results are expected in Q1 2017.
Professor Stephen Holgate CBE said: "New treatments to prevent
severe exacerbations are needed and most exacerbations are caused
by the common cold and flu. Unexpectedly, colds did not cause as
many asthma exacerbations as were predicted in this clinical trial
population. We hope to learn from the results of this trial which
population within severe asthma, or other respiratory diseases,
will most benefit from AZD9412 and should be included in future
trials."
Richard Marsden, Synairgen's Chief Executive Officer, said:
"Although the exacerbation rate in the entire population to date
has been lower than we expected based on the assumptions behind the
trial design, we look forward to reviewing the other clinically
important qualitative and quantitative measures of the potential
effectiveness of AZD9412, building on the experience of our
previous trial outcomes in this section of the asthmatic
population."
Background to 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 has
shown that common colds can cause severe exacerbations of asthma
and that boosting the antiviral defences of the lung with AZD9412
(inhaled interferon beta, an antiviral protein) during this time
could prevent exacerbations from developing.
The INEXAS trial design:
The target number of patients recruited into any clinical trial
is based on assumptions about the number of events and the
anticipated benefit of the drug. In the INEXAS trial there have
been far fewer exacerbations ("events") than anticipated possibly
due to patient selection and environmental/regional factors, and
therefore the trial's primary outcome could be hard to conclude
within its current design.
-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 / 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. 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
www.synairgen.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
RESAKDDNBBDBFKD
(END) Dow Jones Newswires
October 12, 2016 02:00 ET (06:00 GMT)
Synairgen (LSE:SNG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Synairgen (LSE:SNG)
Historical Stock Chart
From Apr 2023 to Apr 2024