SOUTHAMPTON: Synairgen plc and Clinigen Group 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.”
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.
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). www.synairgen.com
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.