Synairgen to begin trial of potential Covid-19 therapy
Synairgen
6.49p
16:49 26/04/24
Respiratory drug discovery company Synairgen has received expedited approvals from the Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct a trial of ‘SNG001’, an inhaled formulation of interferon-beta-1a, in Covid-19 coronavirus patients, to potentially assist with the global virus pandemic.
FTSE AIM All-Share
755.28
17:14 26/04/24
Pharmaceuticals & Biotechnology
22,773.26
16:59 26/04/24
The AIM-traded firm described Covid-19, which is caused by the SARS-CoV-2 virus, is a global threat, with an “urgent need” to assess new treatments to prevent and effectively treat the severe lower respiratory tract illness that can occur with the disease.
Older people and those with comorbidities such as heart and lung complications or diabetes are said to be at greatest risk of developing severe or fatal disease.
It explained that interferon beta is a naturally occurring protein, which orchestrates the body's antiviral responses.
There was evidence that deficiency in IFN-beta production by the lung could explain the enhanced susceptibility of the at-risk patient groups to developing severe lower respiratory tract disease during respiratory viral infections.
Additionally, viruses, including coronaviruses such as SARS-CoV-2 and MERS-CoV, had evolved mechanisms which suppress endogenous IFN-beta production, thus helping the virus evade the innate immune system.
The addition of exogenous IFN-beta before or during viral infection of lung cells could either prevent or greatly diminish cell damage and viral replication, respectively.
Synairgen said SNG001 is a formulation of IFN-beta-1a for direct delivery to the lungs via nebulisation.
It is pH neutral, and free of mannitol, arginine and human serum albumin, making it suitable for inhaled delivery direct to the site of action.
SNG001 could prove to have an important role to play in outbreaks such as the current Covid-19 pandemic, the company said, particularly in respect of the population at highest risk of being severely affected by this and similar viruses.
It said SNG001 was identified in the WHO's landscape analysis of therapeutics as at 17 February as the only phase 2, 3 and observational therapy delivered by the inhaled route.
Two phase 2 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.
The company also showed that treatment with inhaled SNG001 reduced lung viral load and lung pathology in an in vivo swine flu-driven model of viral pneumonia.
At the time of the MERS-CoV outbreak in 2013, Synairgen collaborated with the National Institutes of Health (NIH) in the United States to show that SNG001 could protect against MERS-CoV infection of lung cells in vitro.
Synairgen said its phase 2 trial in Covid-19 patients, dubbed ‘SG016’, would be a double-blind, placebo-controlled trial.
Initially, the pilot phase of the study would involve 100 Covid-19 patients, would take place across a number of NHS trusts, and had been adopted by the NIHR Respiratory Translational Research Collaboration, which is comprised of leading centres in respiratory medicine in the UK whose experts were working to accelerate development and discovery for Covid-19.
A successful outcome from the pilot phase would inform onwards progression of SNG001 in Covid-19 patients, with the trial expected to commence imminently.
Since the outbreak of Covid-19, the company said it had been approached by, and was in discussion with, a number of other medical, scientific, and governmental bodies in the UK, the US and elsewhere, seeking to investigate novel therapeutics in this area.
It added that it was now close to completing a phase 2 study in chronic obstructive pulmonary disease (COPD) patients with confirmed respiratory viral infections and pre-existing significant impairment of lung function.
With 109 out of a target 120 participants already dosed, the trial had been paused to minimise the chance of vulnerable patients being exposed to further infection risk and to minimise distraction for respiratory staff in the UK hospitals and general practitioner sites conducting the trial, which would be at the forefront in dealing with patients suffering from Covid-19.
The firm said it was currently exploring ways to adapt the trial to enable patients in the pre-treatment pool to be dosed if they became infected with SARS-CoV-2.
Early data from the double-blind, placebo-controlled trial demonstrated that the antiviral responses in the lung, assessed using sputum biomarkers, were similar to those observed in the asthma trial, where the company saw clinical benefit in lung function.
“We have worked intensively with the relevant authorities and collaborators to enable SNG001 to be assessed in Covid-19 patients,” said chief executive officer Richard Marsden.
“SNG001 has been well tolerated in clinical trials in over 200 respiratory patients to date and has accelerated lung function recovery in two phase 2 asthma trials in patients with a cold or flu infection.
“A successful outcome from this trial in COVID-19 patients would be a major breakthrough in the fight against this coronavirus pandemic.”
At 1115 GMT, shares in Synairgen were up 15.92% at 28.4p.