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NEW YORK, July 10, 2025 /PRNewswire/ — Klotho Neurosciences, Inc. (Nasdaq: KLTO), a biotechnology pioneer focused on gene therapies for neurodegenerative diseases, has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for its novel ALS therapeutic candidate KLTO-202.
The designation provides Klotho with critical development incentives for KLTO-202, which leverages a proprietary gene delivery system to address amyotrophic lateral sclerosis (ALS), a devastating condition affecting fewer than 200,000 Americans. FDA orphan status accelerates pathways to market through tax credits, fee waivers, and potential seven-year commercial exclusivity.
“This milestone validates our scientific approach to combat this universally fatal disease,” stated Dr. Joseph Sinkule, CEO of Klotho Neurosciences. “Our therapy uniquely targets the neurologic insult causing motor neuron degradation while delivering protective effects through systemic s-KL protein expression. Having witnessed ALS’s toll personally, we’re driven to pioneer transformative solutions.”
ALS, historically termed Lou Gehrig’s disease after the legendary Yankees player whose career it cut short, progressively destroys motor neurons. Diagnosed annually in approximately 5,000 U.S. patients, it remains fatal with limited treatment options.
Following successful proof-of-concept studies in ALS animal models, Klotho is advancing manufacturing development for KLTO-202 and preparing for regulatory discussions with U.S. and European agencies. The therapy utilizes a muscle-specific delivery mechanism to target the neuromuscular junction—the critical interface between nerve and muscle tissue.
Klotho continues developing its pipeline of gene therapies targeting age-related neurological disorders, leveraging its proprietary s-KL protein platform. While KLTO-202 shows promise, it remains investigational and unapproved by regulatory bodies.
For more information, visit the company’s website: www.klothoneuro.com.
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The revision maintains all core scientific and regulatory information while transforming the announcement into an investor-focused business narrative consistent with financial journalism standards.
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