REG - Synairgen plc - Synairgen presents at ATS 2022

SynairgenAnnouncement

16/05/2022 07:00

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RNS Number : 5326L  Synairgen plc  16 May 2022

For Media and Investors

 

Synairgen plc

('Synairgen' or the 'Company')

Synairgen presents detailed analysis of Phase 3 SPRINTER trial evaluating
SNG001 in hospitalised COVID-19 patients at ATS 2022

·    Post hoc analyses conducted in patient populations at greater risk of
progression to severe disease or death suggests that SNG001 may have an
important clinical effect on top of standard of care

 

 

Southampton, UK - 16 May 2022: Synairgen plc (LSE: SNG), the respiratory
company developing SNG001, an investigational formulation for inhalation
containing the broad-spectrum antiviral protein interferon beta, today
announces the first presentation of the full data analysis from its Phase 3
SPRINTER trial evaluating the efficacy and safety of SNG001 in patients
hospitalised with COVID-19.

SPRINTER (SG018; NCT04732949) was a global, randomised, placebo-controlled,
double-blind clinical trial assessing the efficacy and safety of inhaled
SNG001 for the treatment of adults hospitalised due to COVID-19 who required
treatment with supplemental oxygen. The trial recruited a total of 623
patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on
top of standard of care (SOC).

The data from this pivotal trial will be presented today at the Clinical
Trials Symposium of the American Thoracic Society 2022 (ATS 2022)
International Conference, being held in San Francisco, California from
13-18 May 2022. A separate poster presentation is scheduled for 17 May 2022.

Synairgen announced in February 2022 that the Phase 3 SPRINTER trial did not
meet the primary endpoints of discharge from hospital and recovery. There was,
however, an encouraging signal in reduction in the relative risk (RRR) of
progression to severe disease or death within 35 days (25.7% 1  (#_ftn1)
reduction in the Intention-to-Treat population and 36.3% reduction in the Per
Protocol population). 2  (#_ftn2)

To assess the strength of this signal and identify specific patient
populations that might benefit most from treatment, post hoc analyses were
performed on groups of patients recognised to be at greater risk of developing
severe disease in hospital. These analyses included patients ≥65 years old,
those with co-morbidities associated with worse COVID-19 outcomes, and those
who, at baseline, despite receiving low flow oxygen, had clinical signs of
compromised respiratory function (defined as oxygen saturation of ≤ 92% or
respiratory rate ≥ 21 breaths/min).

These analyses showed stronger treatment effects with SNG001 in these
high-risk patient sub-groups, with the strongest effect observed in those who
had clinical signs of compromised respiratory function. In these patients, who
represented approximately one-third of the SPRINTER trial population, SNG001
significantly reduced the risk of progression to severe disease and death
compared to placebo by 70% in the Per Protocol population (Odds Ratio (95%
Confidence Interval) 0.23 (0.06, 0.98); p=0.046).

SNG001 was well tolerated in the SPRINTER trial with a favourable safety
profile consistent with previous studies:

·    The proportion of patients with any treatment-emergent adverse events
(TEAE) related to study treatment was 22.6% for SNG001 vs. 25.4% for placebo.

·    The proportion of patients with any serious TEAE was 12.6% for SNG001
vs. 18.2% for placebo.

·    The proportion of patients with a serious respiratory 3  (#_ftn3)
TEAE was 4.7% for SNG001 vs. 9.9% for placebo.

Phillip Monk, Ph.D., Chief Scientific Officer of Synairgen, said: "The post
hoc analyses presented at the ATS conference today suggest that SNG001 may be
having a beneficial effect with respect to prevention of severe disease or
death. These results provide a strong clinical rationale to continue to
investigate SNG001 in a trial evaluating progression and/or mortality in
hospitalised patients with COVID-19 and more widely in patients with severe
viral lung infections."

Tom Wilkinson, Chief Investigator of the SPRINTER trial and Professor of
Respiratory Medicine, University of Southampton, said: "The improvement in
standard of care for COVID-19 means that most patients are currently
discharged fairly rapidly from hospital; however, this further analysis shows
that some patients struggle in their battle with the virus and show signs of
respiratory compromise, with faster breathing rates and lower oxygen
saturations, despite being on oxygen. For these higher-risk patients, there
remains an urgent need for new treatment options, and this analysis suggests
that SNG001 could be a potentially efficacious treatment option for them."

The full analysis of the Phase 3 SPRINTER trial data will be submitted for
publication in a peer-reviewed journal. A company recording of the ATS
presentation will be available on the Synairgen website by 12:00 Pacific
Daylight Time/20:00 British Summer Time today, and for ATS members, the
symposium recording will be available on the ATS website.

SNG001 is not approved for use anywhere in the world.

For further information on the ATS International Conference visit:
https://conference.thoracic.org/ (https://conference.thoracic.org/)

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No. 596/2014 ('MAR').

For further enquiries, please contact:

Synairgen plc

Brooke Clarke, Head of Communications

Media@synairgen.com (mailto:Media@synairgen.com)

Tel: + 44 (0) 23 8051 2800

 

finnCap (NOMAD and Joint Broker)

Geoff Nash, Kate Bannatyne, Charlie Beeson (Corporate Finance)

Alice Lane, Sunil de Silva (ECM)

Tel: + 44 (0) 20 7220 0500

 

Numis Securities Limited (Joint Broker)

James Black, Freddie Barnfield, Duncan Monteith

Tel: + 44 (0) 20 7260 1000

 

Consilium Strategic Communications (Financial Media and Investor Relations)

Mary-Jane Elliott, Jessica Hodgson, Namrata Taak

cscsynairgen@consilium-comms.com (mailto:cscsynairgen@consilium-comms.com)

Tel: +44 (0) 20 3709 5700

 

MKC STRATEGIES, LLC (US Media Relations)

Mary Conway

MConway@MKCStrategies.com (mailto:MConway@MKCStrategies.com)

Tel: +1 516-606-6545

 

Notes for Editors

About SPRINTER (SG018) trial

The SPRINTER trial (SG018; NCT04732949) was a global Phase 3, randomised,
placebo-controlled, double-blind, clinical trial assessing the efficacy and
safety of inhaled SNG001 on top of standard of care (SOC) for the treatment of
adults hospitalised due to COVID-19 requiring treatment with supplemental
oxygen by mask or nasal prongs. Patients requiring high-flow nasal oxygen
therapy, non-invasive ventilation, or endotracheal intubation (invasive
ventilation) at randomisation were excluded. COVID-19 was confirmed using a
validated molecular test for the presence of the SARS-CoV-2 virus.

About SNG001

SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for
inhalation that is delivered directly into the lungs using a mesh nebuliser,
currently being investigated as a potential host-directed antiviral treatment
for patients hospitalised with COVID-19. SNG001 has broad potential
applicability for patients hospitalised with respiratory symptoms due to viral
infections such as influenza, Respiratory Syncytial Virus (RSV) and
para-influenza.

The SARS-CoV-2 virus has been shown to suppress the production of IFN-beta, a
naturally-occurring protein that orchestrates the body's antiviral defences,
with the aim of evading host immune responses. By administering IFN-beta into
the lungs, the aim is to correct this deficiency, potentially switching back
on the lungs' antiviral pathways to clear the virus. SNG001 has been shown to
demonstrate potent in vitro antiviral activity against a broad range of
viruses including SARS-CoV-2 and Alpha, Beta, Gamma, Delta and Omicron
variants.

About Synairgen

Synairgen is a UK-based respiratory company focused on drug discovery,
development and commercialisation. The Company's primary focus is developing
SNG001 (inhaled interferon beta) for the treatment of severe viral lung
infections, including COVID-19, as potentially the first host-targeted,
broad-spectrum antiviral treatment delivered directly into the lungs. SNG001
has been granted Fast Track status from the US Food and Drug Administration
(FDA). Founded by University of Southampton Professors Sir Stephen Holgate,
Donna Davies and Ratko Djukanovic in 2003, Synairgen is quoted on AIM (LSE:
SNG). For more information about Synairgen, please see www.synairgen.com
(http://www.synairgen.com) .

 

 1  (#_ftnref1) This was reported as 27.1% in the topline analysis in February
2022 but changed between 35- and 90-day database lock.

 2  (#_ftnref2) The main reason patients were excluded from the Per Protocol
population was failure to receive two full doses in the first three days of
treatment.

 3  (#_ftnref3) Respiratory, thoracic and mediastinal system organ class

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