News & Events zu Satellos Bioscience Inc (MSLE)MSLESatellos Bioscience Inc

Satellos Secures U.S. Patent for Forazapadin

Satellos announced that the United States Patent and Trademark Office has issued U.S. Patent No. 12,747,245, entitled "AP2 associated kinase 1 inhibitors and uses thereof." The patent includes composition of matter claims covering forazapadin, Satellos' lead clinical-stage drug candidate, as well as a broader class of AAK1 inhibitors and related compounds within the company's muscle regeneration platform. The composition of matter patent provides intellectual property protection through Sept. 6, 2044. In addition, the company may be eligible for a patent term extension for forazapadin following future U.S. marketing approval, potentially extending patent protection beyond the current expiration date. Following potential U.S. marketing approval of forazapadin, the company intends to seek to have this patent listed in the FDA's approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.

Satellos Bioscience Completes Enrollment for BASECAMP Clinical Trial

Satellos Bioscience announced that enrollment has been completed for BASECAMP, the company's Phase 2 clinical trial evaluating forazapadin for the treatment of Duchenne muscular dystrophy, DMD, in ambulatory boys 7 to 10 years of age. Forazapadin is an orally administered, small molecule drug candidate designed to restore muscle regeneration in people living with DMD, facioscapulohumeral muscular dystrophy, FSHD, and potentially other degenerative muscle diseases.

Satellos Bioscience Receives FDA Clearance for Forazapadin Clinical Trial

Satellos Bioscience announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for forazapadin for the treatment of facioscapulohumeral muscular dystrophy, FSHD. The company plans to initiate a Phase 2 clinical study in FSHD in the fourth quarter of 2026. Satellos also announced that the FSHD Canada Foundation has agreed to provide up to $5M in non-dilutive financing toward the clinical development of forazapadin in FSHD. "We believe the biology targeted by forazapadin has the potential to address significant unmet needs in degenerative muscle diseases, and our expansion into FSHD reflects the broad potential of our muscle regeneration approach," said Frank Gleeson, co-founder and chief executive officer of Satellos. "Progress in medicine happens when researchers, clinicians, industry partners and advocacy organizations come together around a common goal, and we are grateful to the FSHD Canada Foundation for its partnership and confidence in our work. This support is expected to enable us to advance forazapadin into clinical development in FSHD and extend our muscle regeneration strategy to a second patient community."