Jul 28, 2023

Belite Bio Doses First Patient in Phase 3 Clinical Trial for Advanced Dry AMD (GA) Therapy

Eye On the Cure Research News

The company’s emerging, oral treatment is designed to slow vision loss

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Belite Bio, a biopharmaceutical company developing therapies for retinal degenerative diseases, has dosed the first patient in its Phase 3 PHOENIX clinical trial of Tinlarebant for the treatment of geographic atrophy (GA), the advanced form of dry age-related macular degeneration. The global, placebo-controlled PHOENIX trial will enroll approximately 430 people with GA. Patients will be evaluated for two years.

Tinlarebant is an emerging oral medication designed to slow vision loss by reducing the growth rate of lesions — i.e., areas of retinal cell loss — associated with GA, a leading cause of blindness in people 55 and older, and Stargardt disease, the leading form of inherited, early-onset macular degeneration.

Belite also has its DRAGON Phase 3 clinical trial for Tinlarebant underway for adolescent patients with Stargardt disease.

In many macular conditions, retinal cell loss is caused by the accumulation of toxic byproducts associated with vitamin A metabolism. Tinlarebant was developed to reduce formation of these toxins.

Vitamin A is a nutrient that is essential for vision — it binds with proteins known as opsins to enable photoreceptors (rods and cones) to respond to light. However, damaging toxic byproducts from vitamin A processing accumulate in people with many macular diseases. The macula, the central region of the retina, enables people to read, drive, and see faces. Macular degenerations cause loss of central vision and visual acuity.