Synairgen plc - Interim results for the six months ended 31 December 2009
08 Feb 2010
Synairgen plc (LSE: SNG), the respiratory drug discovery and
development company with a particular focus on viral defence in
asthma and COPD, today announces its interim results for the six
months ended 31 December 2009.
· August 2009, interferon-beta
('IFN-beta') patent granted in US;
· August 2009, recruitment
completed for SG004, a Phase I study of inhaled
IFN-beta in moderate asthmatics;
· November 2009, analysis of
safety results of SG004 confirms inhaled
IFN-beta was well-tolerated, causing no adverse effect on standard
measures of
lung function and inflammation;
· November 2009, multiple
biomarkers from SG004 study confirm antiviral
proof of mechanism of inhaled IFN-beta;
· Successful in vitro testing
of IFN-beta in other respiratory viruses:
RSV, H1N1 'swine flu' and seasonal flu, confirming potential
breadth of inhaled
IFN-beta antiviral therapy;
· Progression of preparation
for commencement of Phase II studies from
Spring 2010, with scope of first study broadened to include flu;
and
· Board additions - Phill
Monk, Chief Scientific Officer and Paul Clegg,
Non-Executive Director.
· Research and development
expenditure for the period: £1.04m (six
months ended 31 December 2008: £1.04m);
· Post-tax loss for the
period: £1.21m (six months ended 31
December 2008: loss of £1.14m); and
· Net funds at 31 December
2009 of £6.84m (31 December 2008:
£3.02m).
Commenting on the results, Simon Shaw, Chairman of
Synairgen, said: "During the period, we have successfully
completed a Phase I study in asthma patients, showed that the
lungs' antiviral defence mechanism is switched on by inhaled
interferon beta, and extended its potential application to
influenza viruses. On the back of these achievements and the
imminent commencement of our Phase II study programme, we are
well-positioned to execute our strategy of out-licensing this
exciting programme in 2011."
For further information, please contact:
Synairgen
plc Tel:
+44 (0) 23 8051
2800
Richard Marsden, Chief Executive Officer
John Ward, Finance
Director
Matrix Corporate Capital
LLP
Tel: +44 (0) 20 3206
7000
Alastair
Stratton
Anu
Tayal
Threadneedle
Communications
Tel: +44 (0) 20 7653
9850
Graham
Herring
Josh
Royston
Chairman's Statement
OPERATING REVIEW
During the period, we have made significant strides in the development of our inhaled interferon beta ('IFN-beta') programme, which has been expanded to include asthmatic patients with influenza. We are on track to commence our first Phase II study this Spring.
IFN-beta for the treatment of viral infection in asthma and COPD sufferers Synairgen's proprietary formulation of inhaled interferon beta-1a (SNG001) is being developed to prevent exacerbations of asthma and chronic obstructive pulmonary disease (COPD) caused by common cold and influenza viruses. The majority of hospitalisations for asthma and COPD patients are associated with such virus infections, causing significant suffering and health economic burden. SNG001 has been shown to protect asthmatic and COPD cells in in vitro models of lung infection.
Successful completion of Phase I safety study in
controlled asthmatic subjects
In August 2009,
we finished recruitment for the Phase I study (SG004) in controlled
asthmatic subjects who take the mainstay therapy of inhaled
corticosteroids. SG004, conducted by Synairgen in Southampton
and Medicines Evaluation Unit in Manchester, was an escalating dose
study with a treatment period of up to 14 days and was conducted in
40 subjects. In November, we were pleased to report that
SNG001 was well tolerated at all dose levels.
Confirmed antiviral activity in the
lungs
Interferons have been administered by injection to many patients
with viral conditions such as hepatitis. In clinical trials,
injectable interferon beta invokes an antiviral response that can
be measured in blood samples; principally through the detection of
specific antiviral biomarkers, such as neopterin, MXA and
2-5-OAS. Our approach is aimed at "switching on" the
antiviral defences in the lungs whilst avoiding significant
activity elsewhere in the body.
During 2009, we developed and validated techniques to measure antiviral defences in the lungs of clinical trial volunteers through the level of the biomarker neopterin. Analysis of the samples from SG004 showed that levels of neopterin and three other biomarkers in sputum (phlegm) produced by the subjects were significantly increased above placebo. This gives us the strongest evidence to date that inhaled IFN-beta sets in motion the lungs' antiviral defences.
The combination of a clear safety signal and the ability to activate antiviral defences in the lung increases our confidence of success. The proof of concept trials (SG005 in asthma and SG006 in COPD) are designed to demonstrate that SNG001 protects the lungs of these "at risk" patients during respiratory virus infection.
On-going preparation for commencement of Phase II studies in asthma and COPD Synairgen's Phase II asthma study will compare SNG001 against placebo in 'exacerbation-prone' asthma patients. Applications to the MHRA and an Ethics committee were submitted in January 2010. The study is scheduled to start in the Spring across a number of clinical trial centres in the UK and is designed to detect a difference in symptom scores during naturally-acquired respiratory virus infections, including influenza. We intend to commence a study for COPD later in the year.
Activity against other viruses
During 2009, the H1N1 pandemic became front page news across the
world. Up until the summer of 2009, Synairgen has conducted
most of its work using variants of the rhinovirus (the main cause
of the common cold), which accounts for two-thirds of respiratory
virus infections. Unlike other therapeutic approaches, such
as Tamiflu and Relenza , which target one virus type, SNG001
is potentially able to afford broad protection against common
respiratory viruses and in this period we have carried out a number
of in vitro experiments to support this. In September,
Synairgen reported that SNG001 has activity
against respiratory syncytial virus (RSV). Then in November
we announced that the Health Protection Agency (Porton Down) had
shown that SNG001 protects airway cells from H1N1 'swine
flu'. Since then, we have also completed in vitro experiments
which confirm that SNG001 is similarly protective against seasonal
influenza.
Successful completion of this work against a broad range of flu viruses will place SNG001 as a potential front line antiviral defence for "at risk" asthmatic and COPD patients, who make up a significant proportion of the hospitalised cases during influenza outbreaks. It is also well known that many viruses other than influenza cause significant complications in these patients. Evidence that SNG001 is active against a multitude of respiratory viruses enhances the chance of demonstrating efficacy in our forthcoming proof of concept (Phase II) clinical trials and accordingly we have broadened the first Phase II clinical trial to encompass a broad range of respiratory viruses including flu.
Out-licensing strategy and IFN-beta intellectual
property
Synairgen plans to out-license the
SNG001 programme upon successful completion of the proof of concept
Phase II studies. As part of this package, we were pleased to
see that our pivotal US patent was granted in August and, following
receipt of the Notice of Allowance from the European Patent Office,
we expect that a similar patent will be granted in the European
Union in the coming months.
FINANCIAL REVIEW
Statement of Comprehensive Income
The
operating loss for the six months ended 31 December 2009 was
£1.44m (six months ended 31 December 2008: loss of
£1.41m). Research and development expenditure was
£1.04m in both periods. During the current period,
expenditure has been focussed on completion of SG004, preparation
for the forthcoming Phase II studies and further in vitro work with
IFN-beta in other respiratory viruses. Other administrative costs
increased to £0.40m (2008: £0.37m). Interest receivable
decreased from £0.09m to £0.05m with the reduction of
interest rates. Research and development tax credits remained
constant at £0.18m (2008: £0.18m). The loss after tax
was £1.21m (2008: loss of £1.14m) and the loss per
share, following the equity issue in June 2009, reduced to 2.02p
(2008: loss of 5.17p).
Statement of Financial Position and cash
flows
Following adoption of the revised IAS1 (Presentation of Financial
Statements), the Balance Sheet has been redesignated as the
Statement of Financial Position. At 31 December 2009, net assets
amounted to £6.85m (31 December 2008: £3.11m),
including net funds of £6.84m (2008: £3.02m).
Cash outflow (including movements in bank deposits) for the six months to 31 December 2009 was £1.10m (six months ended 31 December 2008: £0.98m).
BOARD CHANGES
In September 2009 there were three board changes: Phill Monk, who had joined Synairgen in 2006, was appointed to the Board as Chief Scientific Officer; Susan Sundstrom, following her departure from the University of Southampton, resigned as a non-executive director; and Paul Clegg was appointed as a non-executive director.
OUTLOOK
During the period, we have successfully completed a Phase I study in asthma patients, showed that the lungs' antiviral defence mechanism is switched on by inhaled interferon beta, and extended its potential application to influenza viruses. On the back of these achievements and the imminent commencement of our Phase II study programme, we are well-positioned to execute our strategy of out-licensing this exciting programme in 2011.
Simon Shaw
Chairman
The full text of this announcement is available on RNS.
