Enrolment has completed in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant (Belite Bio) and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD).
Dry AMD is a leading cause of vision loss in older adults. GA is the advanced stage of dry AMD. People living with GA develop lesions within the retina that can impact their vision and diminish the ability to perform everyday activities like reading and driving. As the lesions expand, patients typically experience progressive loss of central vision.
Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in GA patients as well as Stargardt disease type 1 (STGD1). Currently, there are no orally administered treatments for GA and no treatments for STGD1 approved by the United States Food and Drug Administration (FDA). However, Tinlarebant has been granted Rare Pediatric Disease designation, Fast Track Designation, and Breakthrough Therapy Designation in the United States as well as Orphan Drug Designation in the United States, Europe, and Japan. It has also received Sakigake (Pioneer Drug) Designation in Japan for STGD1.
Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in GA patients as well as Stargardt disease type 1
Dr Hendrik Scholl, Chief Medical Officer of Belite Bio said completion of enrolment in the company’s pivotal clinical trial in GA was “a milestone that reflects strong global interest in our investigational therapy”.
The PHOENIX study is ongoing across sites in the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.
Dr Scholl said the United States led enrolment by a significant margin, “underscoring the appeal of a convenient, once-daily oral tablet compared to existing invasive treatment options”.
