Alkeus Pharmaceuticals Announces Presentation of Positive Gildeuretinol Data in Early-Stage Stargardt Patients During the ARVO 2024 Annual Meeting May 5-9

Oral Presentation and Four Posters to Highlight Alkeus’ Progress in Advancing Research to Address Unmet Needs for People Affected by Serious Degenerative Eye Diseases

CAMBRIDGE, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals, Inc. today announced that new positive data from its TEASE-3 clinical trial of gildeuretinol in teenage and young-adult patients with early-stage Stargardt disease will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting being held May 5-9 in Seattle.

Oral Presentation:

  • Gildeuretinol Arrested Stargardt Disease, The TEASE-3 Study (Michael B. Gorin, M.D., Ph.D., UCLA). Paper Presentation No. 3310, May 7, 2:30 p.m. – 2:45 p.m. PDT; Session 334. Retina/RPW Treatment: New drugs, delivery methods, and mechanism of action; Yakima 1, Seattle Convention Center – Arch Building


  • Gildeuretinol Rapidly Replaces Plasma Vitamin A, a Phase 1 Trial (Gabrielle DeBartolomeo, Alkeus). May 8, 2:15 p.m. – 4:00 p.m. and 4:15 p.m. – 5:15 p.m. PDT; Poster Session 441. Retina/RPE: New Drugs, Mechanisms of Action, and Toxicity; Poster 5103, Board A0360
  • Gildeuretinol Enables the Vitamin A Cycle (Hendrik P.N. Scholl, M.D., M.A., Ph.D., Institute of Molecular and Clinical Ophthalmology, Basel). May 9, 11:45 a.m. – 1:30 p.m. and 4:00 p.m. – 5:00 p.m. PDT; Poster Session 535. Retinal Cell Biology; Poster 6438, Board B0987
  • Industry and Academic Leaders Chose Microperimetry as Most Promising Functional Endpoint for Geographic Atrophy Trials (Monica Hennessey, M.P.H., Alkeus). May 9, 8:00 a.m. – 9:45 a.m. and 4:00 p.m. – 5:00 p.m. PDT; Poster Session 505. AMD–4 (clinical research); Poster 5702, Board B0108
  • Clinical Research Professionals Advocate for Reduction of Patient Burden in Clinical Trials for Geographic Atrophy (Adam Qu, Alkeus). May 9, 8:00 a.m. – 9:45 a.m. and 4:00 p.m. – 5:00 p.m. PDT; Poster Session 505. AMD-4 (clinical research); Poster 5693, Board B0099

About the TEASE Trials

The TEASE trials consist of four clinical studies of gildeuretinol acetate (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 randomized patients with Stargardt disease. Gildeuretinol met its prespecified primary efficacy endpoint showing a 21% reduction in the growth rate of retinal atrophic lesions (p<0.001, square root units, 28% reduction for untransformed areas of retinal atrophic lesions) against untreated patients. Gildeuretinol was well-tolerated. The TEASE-2 trial is an ongoing, fully enrolled, randomized, double-masked, placebo-controlled trial in 80 patients with Stargardt disease, expected to read out topline data in 2025. TEASE-3 is an open-label study designed to assess gildeuretinol in early-stage Stargardt patients. TEASE-4 is an open-label extension study.

About Gildeuretinol Acetate (ALK-001)

Gildeuretinol acetate (ALK-001) is a novel molecule created as a specialized form of deuterated vitamin A designed to reduce the dimerization of vitamin A without disrupting vision. In preclinical studies, gildeuretinol decreased vitamin A dimerization to the normal rate seen in unaffected individuals and prevented retinal degeneration and loss of visual function in animals with Stargardt disease. Gildeuretinol has received breakthrough therapy designation and orphan drug designation from the U.S. Food and Drug Administration. In addition to the TEASE trials, a Phase 3 (SAGA) study of gildeuretinol in 200 patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) is expected to read out topline data in 2024.

About Alkeus Pharmaceuticals

Alkeus Pharmaceuticals, Inc. is a private biopharmaceutical company with headquarters in Cambridge, Mass., backed by institutional investors led by Bain Capital Life Sciences. Founded in 2010, Alkeus is developing therapies for serious diseases of the eye with high unmet need. Alkeus’ breakthrough-designated lead candidate, gildeuretinol acetate (ALK-001), is currently being evaluated in clinical trials for the treatment of Stargardt disease and for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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