Degenerative retinal diseases

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Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy
Globenewswire· 2025-07-02 07:00
Core Insights - Belite Bio has completed enrollment in the PHOENIX trial, a pivotal Phase 3 study evaluating Tinlarebant for geographic atrophy in dry age-related macular degeneration [1][2][3] Company Overview - Belite Bio is a clinical-stage biopharmaceutical company focused on developing therapeutics for degenerative retinal diseases, including Stargardt disease type 1 and geographic atrophy [5] - The company's lead candidate, Tinlarebant, is an oral therapy aimed at reducing retinal toxin accumulation and is currently in multiple clinical trials [5] Clinical Trial Details - The PHOENIX trial is a 24-month, randomized, double-masked, placebo-controlled, multicenter study conducted across several countries, including the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia [3] - The trial aims to evaluate the efficacy of Tinlarebant in slowing the growth of atrophic lesions, a key marker of disease progression in geographic atrophy [2][3] Market Need - Geographic atrophy is a progressive condition that severely impacts vision and quality of life, with no approved oral treatments currently available [2][4] - The completion of enrollment in the PHOENIX trial reflects a significant unmet medical need for patients suffering from this condition [2][4] Regulatory Designations - Tinlarebant has received several designations, including Rare Pediatric Disease designation, Fast Track Designation, and Breakthrough Therapy Designation in the United States, as well as Orphan Drug Designation in multiple regions [4]
Belite Bio to Participate in Four Upcoming Investor Conferences
Globenewswire· 2025-05-12 12:00
Core Insights - Belite Bio, Inc is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for degenerative retinal diseases with significant unmet medical needs [2] - The company is actively participating in four upcoming investor conferences to present its developments and engage with investors [1][3] Company Overview - Belite Bio targets diseases such as Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) associated with advanced dry age-related macular degeneration (AMD) [2] - The lead candidate, Tinlarebant, is an oral therapy aimed at reducing toxin accumulation in the eye and is currently undergoing multiple clinical trials, including a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) for STGD1, as well as a Phase 3 study (PHOENIX) for GA [2] Upcoming Events - The company will present at the Deutsche Bank Depositary Receipts Virtual Investor Conference on May 15, 2025, at 12:30 pm ET [3] - A fireside chat is scheduled for May 20, 2025, at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at NASDAQ [3] - Another fireside chat will take place on May 27, 2025, at the Stifel 2025 Ophthalmology Forum [3] - The Benchmark's Healthcare House Call One-on-One Conference will feature a fireside chat on May 29, 2025, at 12:45 pm ET [3]