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.
Ipsen licenses Simcere Zaiming antibody-drug conjugate for global development
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Ipsen closes Phase II FALKON trial after missing primary endpoint in FOP
Curasight reports first patient dosed in Phase 1 uTREAT trial in brain cancer
Clywedog Therapeutics activates all clinical centres and patient dosing in balomenib Phase 1b study
PRISM BioLab partners with Talus Bioscience to address TF and PPI targets
Thryv Therapeutics reports positive Phase 1 results for THRV-1268