CAMBRIDGE, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc., a biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases, today announced that results from its clinical studies of investigational oral gildeuretinol for the treatment of Stargardt disease (TEASE) and geographic atrophy secondary to age-related macular degeneration (SAGA) will be presented at the 2025 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) being held May 4-8 in Salt Lake City.
Oral Presentations:
- Safety and Efficacy of Oral Gildeuretinol for Stargardt Disease: TEASE-1 Trial
Date: May 5, 2025
Time: 4:30 p.m. to 4:45 p.m. MDT
Presentation Number: 1946
Session: Session 242: Retinitis pigmentosa and IRD
Location: Calvin L. Rampton Salt Palace Convention Center, Ballroom J
Presenter: Benjamin Bakall, M.D., Ph.D., Associated Retina Consultants - Oral Gildeuretinol Treatment in Geographic Atrophy Secondary to AMD in the SAGA Trial: Safety, Efficacy and Patient-reported Outcomes
Date: May 6, 2025
Time: 4:45 p.m. to 5:00 p.m. MDT
Presentation Number: 3623
Session: 349: AMD Clinical research I
Location: Calvin L. Rampton Salt Palace Convention Center, Room: 255ABC
Presenter: David Boyer, M.D., Retina-Vitreous Associates Medical Group
About Alkeus Pharmaceuticals
Alkeus Pharmaceuticals, Inc. is a private biopharmaceutical company dedicated to preserving the sight of individuals impacted by retinal diseases. Based in Cambridge, Mass., Alkeus is backed by institutional investors led by Bain Capital Life Sciences. Alkeus is developing therapies for serious diseases of the eye with high unmet need, with the purpose to preserve the sight of individuals impacted by retinal diseases. Alkeus’ breakthrough-designated lead candidate, gildeuretinol acetate (ALK-001), is a new molecular entity currently being evaluated in clinical trials for the treatment of Stargardt disease and for geographic atrophy secondary to age-related macular degeneration.
About Gildeuretinol Acetate (ALK-001)
Oral gildeuretinol acetate (ALK-001) is a new molecular entity designed to reduce the dimerization of vitamin A without modulating the visual cycle. Gildeuretinol is currently being evaluated in clinical trials for the treatment of Stargardt disease and for geographic atrophy secondary to age-related macular degeneration. Gildeuretinol has received Breakthrough Therapy, Rare Pediatric Disease, Fast Track and Orphan Drug designations for Stargardt disease from the U.S. Food and Drug Administration.
About the TEASE Program
The Tolerability and Effects of ALK-001 on Stargardt diseasE (TEASE) studies consist of four independent clinical studies of oral gildeuretinol (ALK-001) in Stargardt disease, denoted as TEASE-1, TEASE-2, TEASE-3 and TEASE-4. The TEASE-1 study was a randomized, double-masked, placebo-controlled trial in 50 patients with Stargardt disease, and is complete. The TEASE-2 trial is an ongoing, fully enrolled, randomized, double-masked, placebo-controlled trial in 80 patients with moderate Stargardt disease, expected to read out topline data in 2025. TEASE-3, the clinical trial in early-stage Stargardt disease, is an open-label study of gildeuretinol in genetically confirmed patients with early signs of disease visible on retinal imaging, but who have not begun experiencing symptoms of vision loss. TEASE-4 is an open-label extension study.
About the SAGA study
The Study of ALK-001 in GA secondary to age-related macular degeneration (SAGA) was a 24-month, double-masked, randomized, placebo-controlled trial to investigate safety, pharmacokinetics, tolerability and efficacy in 198 patients with geographic atrophy secondary to age-related macular degeneration and is complete.
For further information, contact:
Media@alkeuspharma.com
Website: www.alkeuspharma.com
