Treatment administration has started in the second part of a Phase 2 trial evaluating the safety and efficacy of Synairgen‘s inhaled therapeutic candidate SNG001 in patients with chronic obstructive pulmonary disease (COPD) with a confirmed flu or cold virus.
SNG001 is an inhaled interferon-beta (IFN-beta) therapy developed to help promote the body’s natural antiviral defenses to prevent or reduce lung infections. IFN-beta is produced by lung cells to fight viral infections. With SNG001, researchers hope to boost the body’s antiviral system to fight respiratory infections that tend to worsen COPD symptoms.
“Cold and flu respiratory viruses cause approximately 50% of COPD exacerbations and are the second-most common cause of unplanned hospital admission in England, presenting a significant health risk, and economic burden,” Richard Marsden, CEO of Synairgen, said in a press release.
In this part of the Phase 2 trial (NCT03570359 or SG015), researchers will evaluate the safety and efficacy of inhaled SNG001 in up to 120 COPD patients with a confirmed diagnosis of an upper respiratory infection.
Patients will randomly receive either a placebo or SNG001 once daily for 14 days; follow-up will run two weeks after treatment. The study will assess changes in lung function, COPD symptoms, and antiviral biomarkers. Adverse events will be monitored to analyze SNG001’s safety.
The trial is being conducted at several locations across the United Kingdom.
This section of Part 2 of the trial is based on the successful completion of Part 1, where SNG001’s efficacy was tested in COPD patients with no evidence of a viral infection. Ten patients received either SNG001 or a placebo for three days. The study showed that SNG001 treatment was safe and well-tolerated.
“With no effective broad-spectrum antiviral treatment on the market, we believe treating COPD patients with our wholly-owned product, SNG001, has the potential to enhance greatly the patient’s defenses against viral infection, reduce exacerbations, increase quality of life and reduce hospitalizations. Commencement of Part 2 of this Phase 2 trial in advance of the winter virus season is clearly another key milestone for Synairgen,” Marsden said.
In addition to COPD patients with a cold or flu, SNG001 was also being tested in asthma patients with a respiratory infection in two Phase 2 clinical trials (NCT01126177 and NCT02491684). These studies showed that the drug can improve patients’ lung function and antiviral response.