SNG001 Can Safely Improve Lung Function in COPD Patients With Viral Infections, Interim Data Show

Synairgen‘s anti-viral therapy SNG001 has a good safety profile in people with chronic obstructive pulmonary disease (COPD), Phase 2 trial data show.

The data also indicate that SNG001 induces its intended anti-viral effect, and that it improves lung function in COPD patients with viral lung infections.

“These interim data from our first trial of SNG001 in COPD show that SNG001 could be a valuable novel therapeutic for exacerbating COPD patients,” Richard Marsden, CEO of Synairgen, said in a press release.

Viral infections — such as the common cold or the flu — can aggravate COPD symptoms. Such infections are found in more than half of COPD exacerbations (when symptoms suddenly worsen or “flare up”).

“COPD exacerbations are the second most common cause of unplanned hospitalisation in England, behind cardiovascular disease,” Marsden said.

SNG001 is designed to combat viral infections by boosting the body’s natural anti-viral response. The active agent in SNG001 is interferon beta, a powerful signaling protein that can activate the body’s immune system to fight the viral threat. SNG001 is delivered directly into the lungs using a nebulizer.

An ongoing two-part Phase 2 clinical trial (NCT03570359 or 2017-003679-75) is assessing SNG001 as a possible agent for treating viral infections in people with COPD.

In the first part of the study, 10 COPD patients without viral infections were given SNG001 or a placebo, as a preliminary assessment of safety. Results indicated that the treatment was safe and well-tolerated.

The new results come from an interim analysis (an analysis conducted while the trial is still ongoing) of the second part of the study, which aims to enroll about 120 people with COPD who have viral infections.

Participants will receive either SNG001 or a placebo, and the primary goal of the study is to assess the impact of treatment on lung function and anti-viral immune responses.

The trial is currently recruiting participants at several locations in the U.K. Additional information is available here.

Safety data from the interim analysis were positive: the total number of reported adverse events were similar in participants given SNG001 (45.6%) or the placebo (48.1%). The number of adverse events that were deemed directly related to treatment was lower in the SNG001 group than in the placebo group (15.8% vs. 25%).

These safety data are particularly noteworthy given that the enrolled study population is older (average age 66 years) and has poor lung function.

Sputum analyses showed that SNG001 treatment significantly increased the levels of proteins that are produced as part of an interferon beta-driven anti-viral immune response, namely OAS1 and MX1. This indicates that the medication has its intended effect on the body.

About a third of enrolled participants were experiencing exacerbations when they entered the study, requiring treatment with oral corticosteroids and/or antibiotics — they are referred to as exacerbating COPD participants.

Among these exacerbating COPD participants, those given SNG001 had significantly better lung function than those given the placebo, as measured by peak expiratory flow rate (PEFR) or the maximum speed with which a person can exhale.

The difference in change from morning PEFR at the start of the study between participants receiving SNG001 and the placebo over days 2 to 15 was 25.5 L/min.

There was also a trend towards less participant-reported breathlessness among those given SNG001, though this difference did not reach statistical significance.

The specific types of viral infections treated included many common respiratory viruses, such as influenza and rhinovirus (viruses that cause the common cold). There were also four strains of coronaviruses, though notably not SARS-CoV-2, the coronavirus that causes COVID-19.

Of note, SNG001 is also being investigated as a potential treatment for COVID-19 in a separate clinical trial (NCT04385095). Top-line results have indicated that the treatment reduces the risk of severe disease in hospitalized individuals. This trial is currently recruiting in the U.K.; additional information can be found here.

“Overall,” Marsden said, “SNG001 has now been shown to raise the body’s natural viral defences when challenged by a wide variety of respiratory viruses, indicating that it could be an important treatment in the coming virus season, where there may be coinfection with influenza and other viruses alongside COVID-19.”

“Our immediate priority is to progress SNG001 as a therapeutic for COVID-19 and, as such, our COPD programme will remain paused,” Marsden added. “We are, nevertheless, pleased to provide further evidence that supports SNG001 as a potential treatment for COVID-19 through the safety, biomarker, and efficacy data generated from patients in this interim review of the COPD trial.”