Ren Xing's Subsidiary Reports Positive Secondary Endpoint for Tinlarebant in Stargardt Disease Trial

Ren Xing (6696-TW) announced through its subsidiary Belite that its oral investigational drug LBS-008 (Tinlarebant) has achieved positive secondary efficacy results in the global Phase III clinical trial (DRAGON) for adolescent Stargardt disease (STGD1), following the earlier achievement of the primary efficacy endpoint.

According to Ren Xing, the efficacy data released this time focuses on the analysis of 'quantitative autofluorescence (qAF)', a key biomarker for assessing the accumulation of toxic metabolites known as bisretinoids. At month 25 of Tinlarebant treatment, qAF values in participants remained stable, showing only a minor decrease of approximately 2% from baseline, whereas the placebo group exhibited an increase of about 20% from baseline, demonstrating a statistically significant difference between the treatment and placebo groups.

Regarding the previously announced key data from the DRAGON trial, Ren Xing stated that the study enrolled 104 adolescent STGD1 patients across 11 regions, including the United States, the United Kingdom, Germany, France, Belgium, Switzerland, the Netherlands, China, Hong Kong, Taiwan, and Australia. The trial was conducted as a randomized, placebo-controlled study and successfully met its primary efficacy endpoint, with Tinlarebant demonstrating good tolerability throughout the entire trial period.

Ren Xing noted that Belite has already completed a rolling submission of the New Drug Application (NDA) to the U.S. FDA. The positive secondary endpoint results are expected to further strengthen Tinlarebant’s position as a potential approved therapy for STGD1.