Topline Results from Alkeus Pharmaceuticals’ Study of Oral Gildeuretinol Demonstrate Significant Trend in Slowing GA Progression and Visual Function Improvement

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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Alkeus Pharmaceuticals Announces Data Presentations at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting, October 18-21 in Chicago

CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc. today announced that results from its clinical studies of investigational oral gildeuretinol for the treatment of geographic atrophy secondary to age-related macular degeneration (SAGA) and Stargardt disease (TEASE) will be presented at the 128th annual meeting of the American Academy of Ophthalmology (AAO) being held in Chicago October 18-21, 2024.

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Alkeus Pharmaceuticals Announces Results from the SAGA Study of Oral Gildeuretinol in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

CAMBRIDGE, Mass., – Alkeus Pharmaceuticals, Inc. today announced that the SAGA study of oral gildeuretinol acetate (ALK-001) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) demonstrated a reduction of 0.25 sqmm/year vs. placebo (p=0.07) in the primary endpoint of GA lesion growth rate at 24 months. Gildeuretinol demonstrated a statistically significant reduction in the loss of low luminance visual acuity (LLVA) at 24 months (p=0.03). Gildeuretinol showed a favorable safety profile consistent with other studies of gildeuretinol in Stargardt disease. The topline results will be presented as a late breaker at the 128th Annual Meeting of the American Academy of Ophthalmology (AAO) during Retina Subspecialty Day on Friday, October 18, in Chicago.

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Alkeus Pharmaceuticals Announces Presentation of a TEASE-3 Study Update Showing Progression Stalled in Early-Stage Stargardt Disease Patients Treated with Gildeuretinol

CAMBRIDGE, Mass. – Alkeus Pharmaceuticals, Inc. today announced the presentation of interim data from its TEASE-3 study demonstrating that early-stage Stargardt disease patients treated with gildeuretinol acetate showed no disease progression and remained asymptomatic while on therapy ranging between two and six years. The study update was presented during the 42nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting, being held July 17-20 in Stockholm, Sweden.

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