Belite Bio Presented 12-Month Interim Results of LBS-008 Phase 1b/2 Study in Adolescent Stargardt Disease at AAO Annual Meeting 2022
SAN DIEGO, Oct. 01, 2022 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today presented one-year data from their ongoing two-year Phase 2 clinical study of Tinlarebant in STGD1 as part of the oral presentation series at the Annual Meeting of the American Academy of Ophthalmology (AAO) held during September 30 - October 3, 2022 at McCormick Place, Chicago.
“We are glad that Tinlarebant’s Phase 2 results were presented in a late-breaking oral session at the AAO annual meeting.” said Dr. Tom Lin, Belite Bio’s Chairman and CEO. “The Phase 2 data presented at AAO continue to support Tinlarebant’s safety and efficacy profile over the one-year treatment period and reinforce that this investigational therapy is a promising oral treatment for STGD1 patients.”
Professor John Grigg, the study’s principal investigator and Head Specialty of Ophthalmology at the University of Sydney and Consultant Ophthalmologist at the Sydney Children’s Hospitals Network at Westmead and Sydney Eye Hospital provided a presentation of the interim study data.
To date, all 13 patients have completed one-year of treatment in the ongoing two-year Phase 2 study of Tinlarebant. The results for safety and tolerability assessments, and retinal imaging data have been collected for the evaluation of disease progression. Images from spectral-domain optical coherence tomography imaging, an imaging modality that permits visualization of the retinal anatomy, have shown a stabilization of retinal thickness in many subjects. Fundus autofluorescence imaging shows no autofluorescence expansion (QDAF) in 7 of 13 (53.8%) subjects, and 12 of 13 (92.3%) subjects also show no atrophic lesion (DDAF) after one year of treatment. More importantly, 9 of 13 (69.2%) subjects show a stabilization or improvement in visual acuity throughout the one-year treatment period. A copy of the presentation slides is available at https://investors.belitebio.com/aao-presentation-download-form.
According to the international prospective study of STGD1 (the ProgStar Study), childhood-onset patients with no atrophic lesion (DDAF) at baseline experienced an average lesion growth rate of 0.66 mm2 for the left eyes and 0.74 mm2 for the right eyes at one year. In addition, the Prospective Cohort Study of Childhood-Onset Stargardt Disease by Georgiou et al. reported an average atrophic lesion growth rate (DDAF) of 0.69 mm2/year for children. Belite Bio’s one-year data from ongoing Phase 2 studyshowed an average lesion growth rate of 0.03 mm2/year, demonstrating a promising trend toward halting or slowing the disease progression in the study cohort.
“We are very encouraged by the 12-month treatment results from our Phase 2 Study. While the natural progression of childhood-onset STGD1 is characterized by a rapid visual decline and fast disease progression leading to permanent visual loss at a very young age, the Phase 2 interim data have shown the stabilization in several structural and functional parameters.” said Dr. Tom Lin.
Belite Bio is currently conducting a two-year Phase 2 study and a two-year Phase 3 study (DRAGON) of Tinlarebant in adolescent STGD1 subjects. Belite Bio expects the next data readout in its Phase 2 STGD1 study to occur during the second quarter of 2023 when all subjects will complete 18 months of treatment.
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