Mr. Frank Gleeson reports
SATELLOS GRANTED COMPOSITION OF MATTER PATENT FOR FORAZAPADIN
The U.S. 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's 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.
"The issuance of this composition-of-matter patent represents a significant advancement for Satellos and supports our long-term development and commercialization strategy for the program," said Frank Gleeson, co-founder and chief executive officer of Satellos. "As the strongest form of patent protection for a pharmaceutical product, this patent reinforces the novelty of our approach to restoring muscle regeneration and strengthens our intellectual property (IP) estate surrounding forazapadin. We intend to continue to build on this foundational IP as we advance forazapadin in Duchenne muscular dystrophy (DMD), facioscapulohumeral muscular dystrophy (FSHD) and other degenerative muscle diseases."
Following potential U.S. marketing approval of forazapadin, the company intends to seek to have this patent listed in the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
About forazapadin
Forazapadin is a proprietary, oral, small-molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in degenerative muscle diseases or injury conditions. Forazapadin targets AAK1, a key protein identified by Satellos as believed to be capable of helping restore the body's natural muscle repair and regeneration biology, a fundamental process that is disrupted in DMD, FSHD and other degenerative conditions. By inhibiting AAK1, forazapadin treatment aims to re-establish a biochemical signal believed to be involved in supporting muscle regeneration. Satellos is advancing forazapadin as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status as either a stand-alone or adjunctive therapy, with continuing phase 2 clinical studies including Basecamp, a global, randomized, placebo-controlled study in pediatric participants, and Trailhead, an open-label study in adult participants. A phase 2 clinical study to evaluate the safety, efficacy and tolerability of forazapadin in adults with FSHD is expected to begin in the fourth quarter of 2026.
About Satellos Bioscience Inc.
Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed forazapadin, an orally administered small-molecule AAK1 inhibitor designed to address deficits in muscle repair and regeneration. Forazapadin is being evaluated as a potential disease-modifying treatment for DMD in two phase 2 clinical trials, Basecamp in pediatric participants with DMD and Trailhead in adults living with DMD. An investigational new drug (IND) application to initiate clinical research into forazapadin for the treatment of FSHD has also been cleared. The company has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development.
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