Belite Bio, Inc. to Present Key Findings on Stargardt Disease at 2025 ARVO Annual Meeting

Belite Bio will present research on Stargardt disease at the ARVO Annual Meeting, focusing on ongoing clinical trials.

Quiver AI Summary

Belite Bio, Inc., a clinical-stage biopharmaceutical company focusing on treatments for degenerative retinal diseases, announced that it will present two posters at the upcoming ARVO Annual Meeting from May 4-8, 2025, in Salt Lake City. The presentations will feature baseline patient data from the ongoing DRAGON trial and pharmacokinetic and pharmacodynamic findings from the DRAGON II trial, both related to Stargardt disease. The company’s lead product, Tinlarebant, is an oral therapy designed to reduce harmful vitamin A-based toxins that lead to retinal diseases, having received various designations in the U.S. and Japan. Stargardt disease is the most common inherited macular dystrophy, causing vision loss, and no FDA-approved treatments currently exist. Belite Bio is also conducting further studies involving this therapy for another eye condition, geographic atrophy.

Potential Positives

Belite Bio, Inc. will present new data at the prestigious ARVO Annual Meeting, highlighting ongoing clinical trials for their leading product, Tinlarebant, which addresses significant unmet medical needs in retinal diseases.
The drug, Tinlarebant, has received multiple designations (Fast Track, Rare Pediatric Disease, Orphan Drug, and Sakigake) that indicate its potential importance and priority in the treatment of Stargardt disease and geographic atrophy.
This press release emphasizes the strategic focus on the pediatric demographic in the clinical studies, showcasing the company's commitment to developing therapies for younger patients affected by Stargardt disease.

Potential Negatives

Details about the ongoing trials and presentations may indicate that the company has not yet achieved significant progress or success in bringing its treatments, like Tinlarebant, to market.
The press release does not provide any updates on previous trial results, which may raise concerns about the efficacy and safety of Tinlarebant.
Highlighting that there are currently no FDA approved treatments for Stargardt Disease could imply a challenging market landscape for Belite Bio and its product candidates.

FAQ

What is the purpose of Belite Bio's poster presentations at ARVO 2025?

Belite Bio will present findings from their ongoing DRAGON and DRAGON II trials focused on Stargardt disease.

When and where is the ARVO Annual Meeting taking place?

The ARVO Annual Meeting will be held from May 4–8, 2025, in Salt Lake City, Utah.

What are the key subjects of the poster presentations?

The presentations will cover baseline patient characteristics and pharmacokinetic properties related to Tinlarebant in Stargardt disease.

What is Tinlarebant and its significance?

Tinlarebant is an oral therapy aimed at reducing vitamin A-based toxins to slow the progression of Stargardt disease.

What designations has Tinlarebant received?

Tinlarebant has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in the U.S., among others.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

SAN DIEGO, April 29, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that the Company will give two poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held May 4–8, 2025, in Salt Lake City, Utah. The presentations will highlight baseline patient characteristics from the ongoing DRAGON trial and pharmacokinetic and pharmacodynamic properties from the ongoing DRAGON II trial, both in Stargardt disease.

Poster Presentations:

Title: Baseline Characteristics of Adolescent Stargardt Disease Subjects Participating in a Phase 3 Study of Tinlarebant (DRAGON Trial)
Presenting Author: Dr. Ruifang Sui
Presentation Number: 1463
Session Number: 215
Session Title: Retinitis Pigmentosa and IRD I
Session Date/Time: Monday, May 5, 8:30-10:15 a.m. MDT

Title: Pharmacokinetic and Pharmacodynamic Properties of an Oral Investigational Treatment for Stargardt Disease in Adolescent Japanese Patients
Presenting Author: Dr. Kaoru Fujinami
Presentation Number: 1431
Session Number: 215
Session Title: Retinitis Pigmentosa and IRD I
Session Date/Time: Monday, May 5, 8:30-10:15 a.m. MDT

About Tinlarebant (a/k/a LBS-008)
Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in Stargardt Disease type 1 (STGD1) and also contribute to disease progression in geographic atrophy, or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, Tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Fast Track Designation and Rare Pediatric Disease designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.

Stargardt Disease (STGD1)
STGD1 is the most common inherited macular dystrophy (causing blurring or loss of central vision) in both adults and children. The disease is caused by mutations in a retina-specific gene (ABCA4), which results in progressive accumulation of bisretinoids leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development of retinal imaging systems have helped ophthalmologists identify and monitor disease progression. Currently, there are no FDA approved treatments for STGD1. Importantly, the appearance of bisretinoids, followed by retinal cell death, and progressive loss of vision is also observed in geographic atrophy (GA) patients. Therefore, Belite Bio is evaluating safety and efficacy of Tinlarebant in GA patients in a 2-year Phase 3 study (PHOENIX).

About Belite Bio
Belite Bio is a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite’s lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. For more information, follow us on Twitter , Instagram , LinkedIn , Facebook or visit us at www.belitebio.com .

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