Why Is Belite Bio Stock Gaining Monday?

Belite Bio Inc (NASDAQ:BLTE) on Monday unveiled additional secondary endpoint statistics from its ongoing Phase 3 DRAGON trial.

Following the announcement, the stock gained over 3%.

The latest clinical data specifically highlights the performance of its drug candidate, tinlarebant, in treating Stargardt disease type 1 (STGD1).

Unmet Medical Needs In Stargardt Disease

STGD1 stands as the most frequently occurring inherited macular dystrophy, impacting both children and adults alike.

The root cause stems from specific mutations found within the ABCA4 gene, a gene that is exclusively associated with the retina.

When this gene is mutated, it triggers a continuous and progressive gathering of substances known as bisretinoids.

Over time, this toxic accumulation drives the death of retinal cells and results in an increasingly severe loss of central vision for the patient.

Divergence In Toxic Accumulation

The newly presented secondary data showcased a notable divergence between the treatment and placebo cohorts, particularly regarding quantitative autofluorescence (qAF).

This specific metric acts as a crucial marker for tracking the dangerous accumulation of toxic bisretinoids in the retina.

At the 25-month mark of the clinical evaluation, individuals who were administered tinlarebant demonstrated qAF measurements that remained either stable or showed a minor decrease of roughly 2% compared to their initial baseline readings.

In stark contrast, those subjects who were randomly assigned to the placebo group experienced an approximate 20% escalation in their qAF values from baseline.

Primary Endpoint Success And Trial Tolerability

Alongside the new findings, the presentation included a review of previously shared encore data.

The expansive Phase 3 DRAGON trial successfully recruited 104 individuals spanning 11 separate global jurisdictions. Patients were assigned to either the therapeutic or placebo group in a two-to-one randomization format.

The study met its primary efficacy endpoint. It reduced the growth rate of retinal lesions by 35.7% compared with the placebo group. The result was both clinically meaningful and statistically significant.

The critical measurement was evaluated through definitely decreased autofluorescence (DDAF) utilizing fundus autofluorescence imaging.

BLTE Stock Price Activity: Belite Bio shares were up 3.11% at $154.74 at the time of publication on Monday, according to Benzinga Pro data.

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