Belite Completes Enrollment in Phase 3 PHOENIX Trial for GA

Belite Bio, Inc. has announced the completion of enrollment in its pivotal phase 3 PHOENIX trial, a major milestone in the development of Tinlarebant for the treatment of geographic atrophy (GA) in dry age-related macular degeneration (AMD).

About the PHOENIX Phase 3 Study

The PHOENIX trial is a 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the safety and tolerability of Tinlarebant and its potential to reduce the growth rate of atrophic lesions in patients diagnosed with GA. The multicenter trial is being conducted across sites in the United States, the United Kingdom, France, the Czech Republic, Switzerland, China, Taiwan, and Australia.

Leadership Perspectives on Reaching This Milestone

Tom Lin, chairman and CEO of Belite Bio, highlighted the importance of completing enrollment:

“Completing enrollment in the PHOENIX trial marks an important milestone for Belite Bio as we advance our lead candidate, Tinlarebant, for the treatment of geographic atrophy. This achievement brings us one step closer to evaluating the potential of Tinlarebant to slow atrophic lesion growth in this serious and progressive disease for which there are no approved oral treatments. There remains a significant unmet need for this patient population. We remain committed to advancing Tinlarebant through late-stage development and look forward to sharing interim results at the midpoint of the PHOENIX trial.”

Hendrik Scholl, MD, MA, chief medical officer at Belite Bio, emphasized the global engagement in this trial:

“We are pleased to announce the completion of enrollment in our pivotal clinical trial in geographic atrophy, a milestone that reflects strong global interest in our investigational therapy. The United States led enrollment by a significant margin, underscoring the appeal of a convenient, once-daily oral tablet compared with existing invasive treatment options.”

Tinlarebant Overview and Regulatory Status

Tinlarebant is an orally administered, once-daily tablet intended as an early intervention to maintain the health and integrity of retinal tissues in patients with Stargardt disease type 1 (STGD1) and geographic atrophy (GA). Currently, there are no FDA-approved treatments for STGD1 and no approved oral treatments for GA. If approved, Tinlarebant would be a novel oral therapy addressing these significant unmet medical needs.

Tinlarebant has received multiple regulatory designations, reflecting its potential to address significant unmet needs. These include Rare Pediatric Disease Designation, Fast Track Designation, and Breakthrough Therapy Designation in the United States, along with Orphan Drug Designation in the United States, Europe, and Japan. Additionally, Tinlarebant has been granted Sakigake (pioneer drug) Designation in Japan for STGD1.