Belite Bio, Inc. Doses First Subject in Pivotal Phase 3 Phoenix Trial Evaluating Oral Tinlarebant for Ga
July 27, 2023 at 05:00 pm EDT
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Belite Bio Inc. announced that, in its pivotal Phase 3 "PHOENIX" trial for subjects with GA, the first subject has been dosed at the Retina Associates of Southern California, a clinical trial site in the United States. Phase 3 PHOENIX Trial Outline 2-yeaprprospective, randomized (2:1, active:placebo, n430 subjects), double-masked, placebo-conolled trial dedesigned to assess the efficacy and safety of daily oral Tinlarebant. Enrollment of GA subjects across multiple centers globally has begun in the third quarter 2023. The primary endpoint will be based upon the slowing of DDAF lesion growth rate from baseline to month 24, compared to placebo. An interim analysis of efficacy and safety is expected to be conducted at
the mid-point of the trial.
Belite Bio, Inc is a clinical-stage biopharmaceutical drug development company. The Company is focused on advancing novel therapeutics targeting retinal degenerative eye disease, such as atrophic age-related macular degeneration (AMD), and autosomal recessive Stargardt disease type 1 (STGD) both of which progressively lead to permanent blindness, and metabolic diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), type 2 diabetes (T2D), and gout. Its lead product candidate, LBS-008 as an oral daily treatment for STGD1 and Geographic Atrophy patients. In STGD1, it is developing LBS-008 as once-a-day tablet treatment to target Retinol binding protein 4 (RBP4) by disrupting vitamin A (retinol) binding to RBP4 which leads to reduced delivery of retinol to the eye and reduced accumulation of toxic vitamin A by-products. Its product candidate also includes LBS-009 an anti-RBP4 oral therapy targeting liver disease, including NAFLD, NASH, and T2D.
BELITE BIO, INC 
