CAMBRIDGE, Mass., December 5, 2024 – Alkeus Pharmaceuticals, Inc. today announced that results from its clinical studies of investigational oral gildeuretinol for the treatment of Stargardt disease (TEASE) will be presented at the 12th International FLORetina ICOOR Congress being held December 5-8 in Florence, Italy.
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CAMBRIDGE, Mass. — Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that gildeuretinol (ALK-001), an investigational oral therapy, has received Rare Pediatric Disease and Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of Stargardt disease.
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CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc. today announced that David Arkowitz, M.B.A. has joined the company as Chief Financial Officer.
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CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) treated with investigational oral therapy gildeuretinol (ALK-001) showed a statistically significant reduction in the GA lesion growth rate of 15.3% vs. placebo from 6 to 24 months (p=0.047). Gildeuretinol also demonstrated a statistically significant visual function improvement, showing 4.4 fewer letters lost (p=0.031) in low luminance visual acuity (LLVA) over 24 months. Gildeuretinol showed a clinically meaningful trend in slowing GA growth rate of 13.4% from baseline to 24 months (p=0.075), the study’s primary endpoint. A trend toward functional benefit in best corrected visual acuity (BCVA) was demonstrated with 3.3 fewer letters lost (p=0.099).
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