REG - Synairgen plc Clinigen Group plc - Synairgen and Clinigen sign Managed Access Program

SynairgenAnnouncement

29/09/2020 07:00

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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 Officer                                         Shaun Chilton, Group Chief Executive Officer

 John Ward, Finance Director                                                      Matt Parrish, Head of Investor Relations

 Tel: + 44 (0) 23 8051 2800                                                       Tel: +44 (0) 1283 495010

 finnCap (NOMAD to Synairgen)                                                     J.P.Morgan Cazenove (NOMAD to Clinigen)

 Geoff Nash, Kate Bannatyne, 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, Olivia Manser, Carina Jurs, Alex Bridge, Kris

 Lam                                                                              Adrian Duffield, Melanie Toyne-Sewell,

 synairgen@consilium-comms.com (mailto:synairgen@consilium-comms.com)              Phillip Marriage

 Tel: +44 (0) 20 3709 5700                                                        clinigen@instinctif.com (mailto:clinigen@instinctif.com)

                                                                                  Tel: +44 (0) 20 7457 2020

 

 

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
(http://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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