Corporate Overview

We are a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting currently retinal degenerative eye diseases with have significant unmet medical needs, such as Stargardt disease (STGD1) or Geographic Atrophy (GA) in advanced dry age-related macular degeneration (dry AMD), in addition to specific metabolic diseases.

We believe our lead product candidate, Tinlarebant, or LBS-008 if approved, would provide a novel treatment option where there currently is none. Tinlarebant is novel oral therapy which is intended to reduce the accumulation of toxins in the eye that cause STGD1 and contribute to GA, or advanced dry AMD. These toxins are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, Tinlarebant reduces the formation of these toxins. In clinical trials, Tinlarebant has demonstrated its target specificity and potency that we believe could be clinically meaningful to treat STGD1 patients. 

We have completed a two-year Phase 2 study of Tinlarebant in adolescent STGD1 subjects, and are conducting a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA. DRAGON study is a multi-center, randomized, double masked, placebo controlled study to evaluate the safety and efficacy of Tinlarebant in the treatment of adolescent STGD1 patients. DRAGON II trial is a combination of phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a phase 2/3, multicenter, double-masked, placebo-controlled, randomized study designed to evaluate the efficacy, safety and tolerability of Tinlarebant in adolescent STGD1 subjects. PHOENIX study is a multi-center, randomized, double‑masked, placebo-controlled study to evaluate the safety and efficacy of Tinlarebant in GA subjects.

Volume

Data Provided by Refinitiv. Minimum 15 minutes delayed.

Upcoming Events

Join our mailing list.

 

Sign up to receive important updates and news from Belite Bio