Policy & Regulation
Woolsey's BRAVYL shows promise in ALS trial
19 June 2024 -

Clinical-stage drug development company Woolsey Pharmaceuticals Inc reported on Wednesday that its BRAVYL (fasudil) has demonstrated positive results in a Phase 2a Amyotrophic Lateral Sclerosis (ALS) study.

BRAVYL significantly reduced Neurofilament Light (NfL), a marker of nerve cell damage, and showed trends towards improved clinical outcomes.

NfL levels decreased by 15% from baseline to 6 months. Since NfL in the ALS population tends to increase by a mean of 11% in 6 months, this suggests that 180 mg/day BRAVYL could potentially reduce NfL up to 26% versus placebo over 6 months.

Additionally, greater decreases in NfL were correlated with less decline in ALS functional scores, suggesting potential clinical benefits.

A separate analysis compared trial data with matched ALS patients. REAL patients showed slower decline in breathing capacity, muscle strength and ALS function compared to controls.

The trial is ongoing with a higher dose being evaluated for safety and efficacy.