On July 2, Lin BioScience, through its subsidiary Belite Bio, Inc., announced that enrollment for the global Phase 3 clinical trial of its oral drug LBS-008 (Tinlarebant) for the treatment of geographic atrophy (GA), the advanced form of dry age-related macular degeneration (dry AMD), has been completed. A total of 500 participants were enrolled across the United States, United Kingdom, France, Czech Republic, Switzerland, mainland China, Taiwan, and Australia. Tinlarebant is positioned to become the world’s first oral treatment for GA, targeting a global market opportunity exceeding USD 20 billion.
Lin BioScience stated that this Phase 3 study is a 24-month, global, multi-country, multi-center clinical trial designed as a randomized (2:1, Tinlarebant: placebo), double-blind, placebo-controlled study. The primary efficacy endpoint is the reduction in the rate of growth of the retinal atrophy area, aiming to assess both the safety and effectiveness of Tinlarebant in GA patients.
Tom Lin, Chairman and CEO of Belite Bio, remarked, “Completing enrollment for this Phase 3 trial marks a significant milestone in the development of our lead candidate, Tinlarebant, for treating GA. This brings us one step closer to potentially addressing a serious and progressively worsening condition for which no oral treatment currently exists. GA remains an area of high unmet medical need, and we are committed to advancing the development of Tinlarebant. We eagerly anticipate interim data from this study.”
Belite’s Chief Medical Officer, Hendrik Scholl, added, “We are pleased to announce that enrollment for this pivotal clinical trial in GA is now complete. This milestone reflects strong global interest in our therapeutic approach. Notably, the U.S. contributed the largest number of participants, highlighting the appeal of a once-daily oral treatment over currently available invasive options.”
David Rhee, principal investigator at one of the fastest-enrolling trial sites, commented, “GA is a chronic, debilitating condition that severely impairs vision and diminishes quality of life. Yet current treatment options remain extremely limited. This study is designed to evaluate Tinlarebant’s ability to slow the progression of retinal atrophy—an important clinical marker of disease advancement. Completing patient enrollment is a crucial step forward, and we are eagerly looking forward to the trial’s results.”
Dry AMD is a leading cause of blindness among the elderly, with GA representing its advanced stage. In GA, lesions develop in the retina, impairing vision and making everyday activities like reading and driving increasingly difficult. As the lesions expand, patients typically experience a gradual loss of central vision. Currently, no oral treatments are approved for GA or for earlier-stage dry AMD, such as intermediate AMD.
Due to the lack of effective oral therapies, dry AMD contributes to an estimated USD 255 billion in global direct medical costs annually. With a vast unmet need and commercial potential, Belite Bio aims to be the first to bring an oral treatment for dry AMD to market—helping preserve vision for millions of patients worldwide and delivering long-term value for shareholders.
Resource: 仁新LBS-008晚期乾性黃斑部病變口服藥 完成三期收案
