REG - Synairgen plc - Data from the US NIH-led ACTIV-2 Phase 2 trial

SynairgenAnnouncement

04/10/2022 07:17

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RNS Number : 6904B  Synairgen plc  04 October 2022

Synairgen plc

('Synairgen' or the 'Company')

Synairgen announces positive data from the US NIH-led ACTIV-2 Phase 2 trial
for SNG001 in home-based participants with COVID-19

·    Fewer participants treated with SNG001 compared to placebo progressed
to hospitalisation (1/110 vs 7/110, P=0.07)

·    SNG001 was well-tolerated with a favourable safety profile consistent
with previous studies

·    High level of adherence to SNG001 treatment at-home was observed,
with 90% of patients completing all doses of the once-daily regimen

Southampton, UK - 4 October 2022: Synairgen plc (LSE: SNG), the respiratory
company developing SNG001, an investigational formulation for inhalation
containing the broad-spectrum antiviral protein interferon beta to treat or
prevent severe viral lung infections, today announces topline data for
participants treated with SNG001 in the US National Institutes of Health
(NIH)/ AIDS Clinical Trials Group (ACTG)-led ACTIV-2 Phase 2 adaptive platform
trial for COVID-19.

Between February and August 2021, 221 symptomatic, non-hospitalised adult
participants with COVID-19 were enrolled in the Phase 2 SNG001 evaluation and
randomised between active drug (N=110 treated) and placebo (N=110 treated 1 
(#_ftn1) ), across 25 US sites.

There were no statistically significant differences between SNG001 and placebo
with respect to the primary outcomes of safety (SNG001 was well-tolerated),
symptom resolution, or virology.

Fewer participants required hospitalisation following treatment with SNG001
(N=1/110,  1% ) compared to placebo (N=7/110,  6% ), an 86% relative risk
reduction, that was not statistically significant (P=0.07; two-sided Fisher's
exact test). There were no deaths in either arm.

There were 13 participants with treatment-emergent Grade 3 or higher Adverse
Events (AE) with four on SNG001  3.6%  and nine on placebo  8.2% .

Based on the study results, the Independent Data Safety Monitoring Board for
ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2
trial in October 2021. Later, in March 2022, the NIH decided to halt all
participant recruitment in the trial due to the significant shift in the
nature of the pandemic which would necessitate a substantial modification of
the study design which was not feasible in a multiple treatment-arm platform
trial of this size.

Richard Marsden, CEO of Synairgen, commented: "The data from the ACTIV-2 trial
in the US showing a non-significant but encouraging 86% relative risk
reduction in hospitalisation following treatment with SNG001 in home-based
patients are very interesting when considered in the context of therapeutic
options for the management of non-hospitalised patients during a pandemic.

"These results are really encouraging and build upon the strong body of
non-clinical and clinical evidence, which includes Synairgen's home-based
trial (SG016) in high-risk patients, 2  (#_ftn2) supporting SNG001's potential
as a broad-spectrum antiviral for a wide range of severe lung infections
including COVID-19. We will now begin to evaluate the full data set and factor
these findings into our development plans."

William Fischer, M.D., University of North Carolina (UNC), a lead investigator
of SNG001 said: "These results, including a decrease in hospitalisations and
adverse events among participants who received SNG001, are promising and
warrant further investigation in a larger Phase 3 clinical trial. SNG001 is
the first nebulized inhaled therapeutic to demonstrate promising results and,
if confirmed in larger studies, could represent a potential treatment option
for people who have COVID-19 but are not hospitalised."

Participants self-administered SNG001 or placebo via a nebuliser at home to
complete 14 daily doses, with the first dose taken either at the study site or
at home, with instructions provided by study staff and through an
instructional video available online on how to take the study medication.
There was a high level of adherence to the once-daily treatment in patients
taking SNG001, with 90% of patients receiving full treatment. The ability to
self-administer is important in the context of a pandemic when the ability of
infected patients to travel to a clinic may be very challenging.

The primary goals of the trial were to evaluate safety, to see if the
investigational therapeutic could reduce the duration of symptoms through
study day 28, and to see if the investigational therapeutic could increase the
proportion of patients with undetectable virus in nasopharyngeal swabs at
specific time points.

Synairgen continues to actively pursue and refine multiple clinical approaches
including company- and investigator-sponsored studies and possibly platform
studies (as and when appropriate), to confirm the most expeditious clinical
development path for SNG001 in patients hospitalised due to a severe viral
lung infection including SARS-CoV-2, influenza, RSV, adenovirus, parainfluenza
and rhinoviruses.

This announcement reports on the reduction in hospitalisations, a key endpoint
for determining efficacy of antivirals for COVID-19. Full results, including
other key endpoints, will be presented and/or published by the NIH in due
course.

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014.

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, 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, Namrata Taak, Lucy Featherstone

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 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) .

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,
which the Company is developing as a potential host-directed antiviral
treatment for patients hospitalised with severe viral lung infections,
including COVID-19. SNG001 has broad potential applicability for patients
hospitalised with respiratory symptoms due to viral infections such as
SARS-CoV-2, influenza, RSV, adenovirus, parainfluenza and rhinoviruses.

Viruses have 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 at concentrations that are achievable following inhaled delivery of
SNG001 including RSV, rhinovirus, various influenza strains including H5N1,
MERS-CoV and SARS-CoV-2 including Alpha, Beta, Gamma, Delta and Omicron
variants of concern.

About ACTIV-2

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was a
public-private partnership to develop a coordinated research strategy to
accelerate the development of the most promising COVID-19 treatments and
vaccines (Protocol ACTIV-2/A5401; "Adaptive Platform Treatment Trial for
Outpatients with COVID-19 (Adapt out COVID)").  ACTIV-2 is an adaptive Phase
2/3 trial testing agents in non-hospitalised adults experiencing mild to
moderate COVID-19 sponsored by NIAID, part of the National Institutes of
Health, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG).

 1  (#_ftnref1) One participant randomized to placebo did not receive study
intervention and was excluded from all analyses. The treated population
therefore included 220 participants (110 SNG001, 110 placebo).

 2  (#_ftnref2) Synairgen conducted a trial of SNG001 in high-risk, home-based
COVID-19 patients (SG016) in which fewer patients treated with SNG001 were
hospitalised (0/56) compared to placebo (2/58). In total across SG016 and
ACTIV-2, 1/165 SNG001-treated home-based COVID-19 patients have been
hospitalised.

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