Southampton, UK – 21 July 2020: Synairgen plc (LSE: SNG), the respiratory drug discovery and development company which originated from research at the University of Southampton, issues clarification with respect to yesterday’s announcement
- The trial of SNG001 in hospitalised COVID-19 patients is a Phase II trial (as clearly stated in the announcements of 18 and 25 March). A Phase II trial is designed to test the efficacy of a drug and takes place before the drug is approved or able to be marketed.
- The protocol was approved by both MHRA and HRA (as detailed in announcement of 18 March) and further details can be found in respect of the full study on the Company’s website https://www.synairgen.com/investors/presentations
- As per the announcement of yesterday, the Company will be working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible. As with any drug undergoing clinical trials, Synairgen will require regulatory approval before SNG001 can be marketed on a commercial basis.
The Company will provide additional updates in due course and will continue with further analysis of the data from the trial.
Notes for Editors
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 and COPD, 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
The COVID-19 study
Synairgen’s clinical trial in COVID-19 patients (SG016) is a double-blind, placebo-controlled trial. The 220 patient trial comprised 100 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, have been recruited across a number of NHS trusts and the trial has been 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, 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 either prevents or greatly diminishes cell damage and viral replication, respectively. 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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