Bravyl (fasudil oral) / Woolsey Pharmaceuticals - LARVOL DELTA

Woolsey Pharmaceuticals Completes B Round Extension To Advance Its ALS Program (PRNewswire) - "Woolsey Pharmaceuticals today announced the successful completion of an extension to its Series B Preferred financing round by existing investors...'We are immensely grateful for the continued support of our investors and remain steadfast and confident in our mission to advance BRAVYL for the treatment of ALS.'....In the fourth quarter of 2024, the company completed enrollment into the high-dose (300 mg/day) cohort of the REAL study, which is assessing BRAVYL (oral fasudil) for the treatment of Amyotrophic Lateral Sclerosis (ALS). This follows promising biomarker and clinical findings from the study's standard-dose cohort. A data readout is expected in June of this year."

Financing • P2 data • Trial status • Amyotrophic Lateral Sclerosis

Woolsey Pharmaceuticals Secures Additional Key U.S. Patent Claims for BRAVYL (oral fasudil) in Treating ALS, Including Reducing Neurofilament Light (NfL) (PRNewswire) - "Woolsey Pharmaceuticals...today announced that the U.S. Patent and Trademark Office (USPTO) has granted additional claims for the use of BRAVYL in treating ALS. This latest patent allowance covers treatment of possible, probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diagnostic criteria, using fasudil or its active metabolite. Further claims are directed to reducing neurofilament light (NfL)."

Patent • Amyotrophic Lateral Sclerosis

Woolsey Pharmaceuticals Reveals Breakthrough Findings Showing Spread of Toxic TDP-43 Pathology Greatly Reduced in BRAVYL (oral fasudil) Treated ALS Patients (PRNewswire) - "To assess whether BRAVYL affects this process, neuron-derived exosomes (NDEs) were isolated from the plasma of two healthy control subjects and from six ALS patients...Key Findings Include: i) Cells treated with baseline NDEs from ALS patients showed marked aggregation and redistribution of TDP-43 into the cytoplasm, indicating that NDEs from ALS patients can confer TDP-43 pathology in this system. ii) In contrast, when exposed to NDEs from the same patients following treatment for 6 months with BRAVYL, TDP-43 aggregation and cytoplasmic redistribution were significantly reduced by 60% (p=0.0006) and 61% (p<0.0001) respectively...Woolsey recently announced it had completed recruitment of 31 ALS patients into the REAL study's high-dose (300 mg/day) cohort...Results are expected in June 2025."

Clinical data • P2 data • Amyotrophic Lateral Sclerosis • CNS Disorders

Phase 2 trial of ROCK inhibitor Bravyl now fully enrolled (ALS News Today) - "A Phase 2a clinical trial testing Rho kinase (ROCK) inhibitor Bravyl (oral fasudil) in people with amyotrophic lateral sclerosis (ALS) has completed patient enrollment for its high-dose group, the company said. While the REAL trial (NTC05218668) was initially slated to only test a 180 mg daily dose of the oral treatment, positive safety and efficacy findings from that group prompted Woolsey Pharmaceuticals to reopen the study and investigate the possible benefits of a 300 mg dose. Results are expected by the middle of next year."

Enrollment closed • P2a data • Amyotrophic Lateral Sclerosis • CNS Disorders