Woolsey Pharmaceuticals Secures Additional Key U.S. Patent Claims for BRAVYL® (oral fasudil) in Treating ALS, Including Reducing Neurofilament Light (NfL)

NEW YORK, Jan. 10, 2025 /PRNewswire/ -- Woolsey Pharmaceuticals, whose mission is to usher in a new era of neurodegenerative disease treatment, 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). In Woolsey's REAL study of BRAVYL at 180mg/day, NfL was reduced by 15% from baseline to six months (p=0.0006). Data from the 300 mg/day REAL cohort is expected in June 2025.

Once issued, this patent will add to Woolsey's existing portfolio, which includes:

• US Patent No. 11,779,588, covering the treatment of sporadic ALS with fasudil or its active metabolite;
• US Patent No.12,128,053, covering treating (sporadic or familial) ALS using Woolsey's proprietary dysphagia-friendly formulation; and
• US Patent Nos. 11,944,633 and 12,115,167, covering a range of dysphagia-friendly formulations of fasudil.

BRAVYL (oral fasudil), a Rho-kinase inhibitor, is an investigational drug believed to work by targeting cellular mechanisms that contribute to neuronal damage and dysfunction. Preclinical and clinical studies suggest that BRAVYL may reduce motor-neuron death, making it a promising candidate for ALS.

"These robust and strategically vital patent claims are part of a 36-patent-family portfolio we have developed for fasudil, a number of which have already issued," said Sven Jacobson, Chief Executive Officer of Woolsey Pharmaceuticals. "These newest patent claims further strengthen our proprietary position around the use of BRAVYL to treat ALS, and complement BRAVYL's ALS Orphan Drug Designations in both the U.S. and Europe."

About ALS

ALS is a fatal neurodegenerative disease characterized by inevitable, and often rapid, decline in patients as the disorder advances. Mean survival time is only two to five years. Accordingly, the ability to impede any worsening represents a meaningful advancement in efforts to enhance the prognosis and quality of life of individuals impacted by the devastating condition.

About Woolsey Pharmaceuticals:

New York-based Woolsey Pharmaceuticals, Inc. is a privately held, clinical-stage pharmaceutical company focused on developing and bringing lifesaving treatments to people affected by ALS and other neurodegenerative diseases.

SOURCE Woolsey Pharmaceuticals, Inc.