Lasting more than eight weeks, chronic cough can cause adverse physical, social, and psychosocial effects on health and quality of life. It is estimated that approximately 26 million adults in the United States suffer from chronic cough, with more than 2.6 million having refractory chronic cough lasting for more than a year. There is no specific therapy approved for refractory chronic cough and treatment options are limited. Currently, the most advanced therapy in development has substantial tolerability issues, including significant taste alteration or loss. BLU-5937 has the potential to be a differentiated treatment option for chronic cough, with little to no effect on taste.
Phase 2b SOOTHE Trial in Refractory Chronic Cough
The Phase 2b SOOTHE trial is evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 300 participants with refractory chronic cough. Building off of the encouraging data generated from the RELIEF trial, SOOTHE is designed to assess the efficacy and safety of BLU-5937 in patients with higher cough count (≥25 awake coughs per hour), while also further investigating the effect of BLU-5937 in patients with lower cough frequency.
An interim analysis is expected in mid-2021, with topline results in the fourth quarter of 2021.
The Phase 2 RELIEF trial was completed in July of 2020. While the primary endpoint of placebo-adjusted reduction in awake cough frequency was not achieved, a numerical difference in favor of BLU-5937 was observed at all doses. In addition, a pre-specified analysis of patients with certain cough frequency achieved highly statistically significant and clinically meaningful reductions in placebo-adjusted awake cough frequency at all doses.
Chronic pruritus – commonly known as chronic itch – is a persistent condition that lasts longer than six weeks which can be debilitating with significant impact on quality of life. It is a hallmark of many conditions, including atopic dermatitis (eczema). It is estimated that atopic dermatitis affects approximately 5% of adults in the United States. Despite currently available treatments targeting this condition, there continues to be a lack of options targeting the burden of pruritus in atopic dermatitis patients.
BELLUS Health believes BLU-5937 may be a viable treatment option for patients with chronic pruritus associated with atopic dermatitis.
Phase 2 BLUEPRINT Trial in Refractory Chronic Cough
The Phase 2 BLUEPRINT trial is evaluating the efficacy, safety, and tolerability of BLU-5937 in approximately 128 adult patients with moderate to severe chronic pruritus associated with mild to moderate atopic dermatitis. Topline results are expected in the fourth quarter in 2021.