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RNS Number : 3718A
Synairgen plc
29 September 2020
Synairgen and Clinigen sign Managed Access Program agreement
with SNG001 for treatment of hospitalised patients with
COVID-19
Southampton and Burton-on-Trent, UK - 29 September, 2020:
Synairgen plc (AIM: SNG, 'Synairgen'), the respiratory drug
discovery and development company and Clinigen Group plc (AIM:
CLIN, 'Clinigen'), the global pharmaceutical and services company,
have signed an agreement to launch a Managed Access Program for
Synairgen's inhaled formulation of interferon beta
(IFN-beta), SNG001, in the UK and the EU for the treatment of
hospitalised COVID-19 patients.
SNG001 is an inhaled formulation of IFN-beta for direct delivery
to the lungs via nebulisation. Synairgen announced positive topline
data generated from 101 patients hospitalised with COVID-19 in its
phase II trial, SG016, on the 20 July 2020. The trial of SNG001 in
hospitalised patients produced very encouraging findings; patients
who received SNG001 were more than twice as likely to recover over
the course of the treatment period compared to those receiving
placebo. Synairgen is currently in discussions with regulatory
agencies to progress this potential COVID-19 treatment.
Richard Marsden, Chief Executive Officer of Synairgen,
commented: "We are working tirelessly to progress SNG001 through
the required clinical and regulatory channels to make this
potentially critical treatment widely available to COVID-19
patients around the world. In the meantime, we are delighted to
partner with Clinigen, whose extensive European experience and
regulatory expertise will support access to treatment with SNG001
for hospitalised patients who most urgently need it."
Shaun Chilton, Clinigen Chief Executive Officer, added: " We are
working with a number of companies who have products being tested
against COVID-19 and are very pleased to be working with Synairgen
to make this highly promising COVID-19 treatment available
internationally. The early study results demonstrate that SNG001
may have a vital role in helping hospitalised patients recover more
quickly from the disease."
Healthcare professionals in the EU can obtain details about the
SNG001 Managed Access Program
by calling the customer service team at +44 (0) 1283 494 340 or emailing
medicineaccess@clinigengroup.com .
Patients seeking information should contact their physician.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No. 596/2014 ('MAR').
- Ends -
Contact details
Synairgen plc Clinigen Group plc
Richard Marsden, Chief Executive Shaun Chilton, Group Chief
Officer Executive Officer
John Ward, Finance Director Matt Parrish, Head of Investor
Tel: + 44 (0) 23 8051 2800 Relations
Tel: +44 (0) 1283 495010
finnCap (NOMAD to Synairgen) J.P.Morgan Cazenove (NOMAD
Geoff Nash, Kate Bannatyne, to Clinigen)
Charlie Beeson (Corporate Finance) James Mitford / Hemant Kapoor
Alice Lane, Manasa Patil (ECM) Tel: +44 (0) 20 7742 4000
Tel: + 44 (0) 20 7220 0500
RBC Capital Markets (Joint
Broker to Clinigen)
Marcus Jackson / Elliot Thomas
Tel: +44 (0) 20 7653 4000
Consilium Strategic Communications Instinctif Partners
(FPR to Synairgen) (FPR to Clinigen)
Mary-Jane Elliott, Sue Stuart, Adrian Duffield, Melanie Toyne-Sewell,
Olivia Manser, Carina Jurs, Phillip Marriage
Alex Bridge, Kris Lam clinigen@instinctif.com
synairgen@consilium-comms.com Tel: +44 (0) 20 7457 2020
Tel: +44 (0) 20 3709 5700
Notes to 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 lung viral defence in asthma, COPD, and COVID-19, uses
its differentiating human biology BioBank platform and
world-renowned international academic KOL network to discover and
develop novel therapies for respiratory disease. Synairgen is
quoted on AIM (LSE: SNG). For more information about Synairgen,
please see www.synairgen.com
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and
services company with a unique combination of businesses focused on
providing ethical access to medicines. Its mission is to deliver
the right medicine to the right patient at the right time through
three areas of global medicine supply; clinical trial, unlicensed
and licensed medicines. The Group has sites in North America,
Europe, Africa and Asia Pacific.
Clinigen now has over 1,100 employees across five continents in
14 countries, with supply and distribution hubs and operational
centres of excellence in key long-term growth regions. The Group
works with 22 of the top 25 pharmaceutical companies; interacting
with over 15,000 registered users across over 100 countries,
shipping approximately 6.4 million units in the year.
For more information on Clinigen, please visit
www.clinigengroup.com
The COVID-19 study
Synairgen's clinical trial in COVID-19 patients (SG016) is a
double-blind, placebo-controlled trial. The 221 patient trial
comprised 101 patients initiated in hospital and 120 patients to be
initiated in the home setting. The patients participating in the
hospital setting, which completed recruitment in May, were
recruited across a number of NHS trusts and the trial was adopted
by the NIHR Respiratory Translational Research Collaboration, which
is comprised of leading centres in respiratory medicine in the UK,
whose internationally recognised experts are working together to
accelerate development and discovery for COVID-19.
COVID-19
COVID-19, caused by the SARS-CoV-2 virus, is a global threat and
there is an urgent need to assess new treatments to prevent and
effectively treat the severe lower respiratory tract illness that
can occur with this disease. Older people and those with
co-morbidities such as heart and lung complications or diabetes are
at greatest risk of developing severe or fatal disease.
Interferon beta (IFN-beta) potential applicability to
COVID-19
Interferon beta is a naturally occurring protein, which
orchestrates the body's antiviral responses. There is evidence that
deficiency in IFN-beta production by the lung could explain the
enhanced susceptibility in 'at-risk' patient groups to developing
severe lower respiratory tract (lung) disease during respiratory
viral infections. Furthermore, viruses, including coronaviruses
such as SARS-CoV-2 and MERS-CoV, have evolved mechanisms which
suppress endogenous IFN-beta production, thereby helping the virus
evade the innate immune system. The addition of exogenous IFN-beta
before or during viral infection of lung cells in vitro either
prevents or greatly reduces viral replication.Synairgen's SNG001 is
a formulation of IFN-beta-1a for direct delivery to the lungs via
nebulisation. It is pH neutral, and is free of mannitol, arginine
and human serum albumin, making it suitable for inhaled delivery
direct to the site of action.
Two Phase II clinical trials in asthma showed that inhaled
SNG001 treatment activated antiviral pathways in the lung, along
with improving lung function in patients with a respiratory viral
infection.
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