Early Trial Findings Hint at SNG001 Aiding COPD Patients with Viral Infections

Viral respiratory infections, like those caused by a cold or flu, may particularly aggravate symptoms of chronic obstructive pulmonary disease (COPD), according to early data from a clinical trial testing the safety and effectiveness of SNG001, an inhaled interferon-beta therapy by Synairgen.

These latest preliminary findings in the two-part Phase 2 study (NCT03570359 or 2017-003679-75) showed a “considerable impact” of these infections on patient-reported measures of COPD symptoms, Synairgen said, compared to measures using this same tool in asthma patients in a separate trial.

Infections caused by the influenza virus and other respiratory viruses increase the likelihood of exacerbations or flares and hospitalizations in people with COPD.

Interferon-beta (IFN-beta) is a naturally produced antiviral compound. SNG001 is an inhaled treatment that delivers IFN-beta directly to the lungs, improving the body’s response to viral infections.

Preclinical studies showed that SNG001 can protect cells of COPD patients from viral infections, and two Phase 2 trials in asthma patients (NCT01126177 and NCT02491684) showed that it boosted the antiviral response, improved lung function, and reduced symptoms.

Synairgen is sponsoring the current placebo-controlled, double-blind Phase 2 trial (NCT03570359 or 2017-003679-75)  in COPD patients, ages 40 to 85, at 15 centers in the U.K.

Its first part tested SNG001 in patients with no sign of a viral infection. Results showed the treatment to be safe and well-tolerated.

The second part, which started dosing patients in October, is assessing changes in lung function, disease symptoms, and antiviral biomarkers in patients with confirmed respiratory viral infections only. They are randomly assigned to either SNG001 or placebo.

These new early findings, announced by Synairgen in a press release, were based on changes in reported symptoms in all those treated to date, recorded via the Breathlessness, Cough and Sputum Score (BCSS). Analysis showed that COPD patients with confirmed influenza infection had a mean increase in BCSS scores of more than two points, which was considered notable.

A mean one-point drop in these scores “represents substantial symptomatic improvement,” the release noted.

As such, a two-point rise implies considerable worsening in COPD patients, and suggests that SNG001 treatment could significantly ease symptoms.

Efficacy data, however, is not yet available in the trial, expected to close during the 2019-20 flu season.

To date, around 35% of the COPD patients enrolled tested positive for a viral infection. Viruses detected included influenza, parainfluenza, rhinovirus, and coronavirus.

A rapid point-of-care test is being used to confirm patients with a viral infection, who could benefit from receiving SNG001, so only they are being dosed.

“Synairgen’s inhaled IFN-beta may provide a novel approach for COPD patients, with the potential to greatly improve the patient’s defenses against viral infection, reduce exacerbations, increase quality of life, and reduce hospitalizations,” Tom Wilkinson, the trial’s chief investigator, said in the release.