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- LBS-008 (aka Tinlarebant) was secure and effectively tolerated in adolescent Stargardt Disease (STGD1) topics at 12-month time level
- The majority of the topics confirmed stabilization of BCVA in not less than one eye
- A pattern for stopping or slowing growth of autofluorescence proceed to be noticed
- No atrophic lesion (DDAF) in 12 of 13 topics on the 12-month therapy interval
- 12-month interim knowledge from the continuing Phase 2 research proceed to indicate stabilization in a number of parameters, together with halting or slowing lesion development, preservation in retinal thickness, discount in Ellipsoid Zone (EZ) defect width, and stabilization of visible acuity.
SAN DIEGO, Oct. 01, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE), a San Diego based mostly medical stage biopharmaceutical drug growth firm concentrating on at present untreatable eye ailments, at present offered one-year knowledge from their ongoing two-year Phase 2 medical research of Tinlarebant in STGD1 as half of the oral presentation sequence on the Annual Meeting of the American Academy of Ophthalmology (AAO) held throughout 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.” mentioned 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 research’s principal investigator and Head Specialty of Ophthalmology on the University of Sydney and Consultant Ophthalmologist on the Sydney Children’s Hospitals Network at Westmead and Sydney Eye Hospital offered a presentation of the interim research knowledge.
To date, all 13 sufferers have accomplished one-year of therapy within the ongoing two-year Phase 2 research of Tinlarebant. The outcomes for security and tolerability assessments, and retinal imaging knowledge have been collected for the analysis of illness development. Images from spectral-domain optical coherence tomography imaging, an imaging modality that allows visualization of the retinal anatomy, have proven a stabilization of retinal thickness in lots of topics. Fundus autofluorescence imaging reveals no autofluorescence growth (QDAF) in 7 of 13 (53.8%) topics, and 12 of 13 (92.3%) topics additionally present no atrophic lesion (DDAF) after one yr of therapy. More importantly, 9 of 13 (69.2%) topics present a stabilization or enchancment in visible acuity all through the one-year therapy interval. A duplicate of the presentation slides is accessible at https://investors.belitebio.com/aao-presentation-download-form.
According to the worldwide potential research of STGD1 (the ProgStar Study), childhood-onset sufferers with no atrophic lesion (DDAF) at baseline skilled a mean lesion development fee of 0.66 mm2 for the left eyes and 0.74 mm2 for the fitting eyes at one yr. In addition, the Prospective Cohort Study of Childhood-Onset Stargardt Disease by Georgiou et al. reported a mean atrophic lesion development fee (DDAF) of 0.69 mm2/yr for kids. Belite Bio’s one-year knowledge from ongoing Phase 2 research confirmed a mean lesion development fee of 0.03 mm2/yr, demonstrating a promising pattern towards halting or slowing the illness development within the research 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.” mentioned Dr. Tom Lin.
Belite Bio is at present conducting a two-year Phase 2 research and a two-year Phase 3 research (DRAGON) of Tinlarebant in adolescent STGD1 topics. Belite Bio expects the subsequent knowledge readout in its Phase 2 STGD1 research to happen in the course of the second quarter of 2023 when all topics will full 18 months of therapy.
About DRAGON Study
The two-year Phase 3 research named DRAGON is a Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TinlaRebant within the Treatment of StArGardt Disease in AdOlesceNt Subjects. DRAGON research is designed to guage the security and efficacy of Tinlarebant in adolescent STGD1 sufferers. To date, Belite Bio has commenced the Phase 3 research within the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong Kong, Taiwan, mainland China and Australia. Approximately 60 sufferers are focused for enrollment on this research with a 2:1 randomization (lively:placebo). For extra info, go to clinicaltrials.gov at https://www.clinicaltrials.gov/ct2/show/NCT05244304?term=belite+bio&draw=2&rank=1)
About LBS-008 (aka Tinlarebant)
Tinlarebant is a novel oral remedy that forestalls the buildup of toxins within the eye that trigger STGD1 and contribute to superior dry AMD. These toxins are by-products of the visible cycle, which relies on the availability of vitamin A (retinol) to the attention. Tinlarebant works by decreasing and sustaining ranges of serum retinol binding protein 4 (RBP4), a service protein that transports retinol to the attention. By modulating the quantity of retinol getting into the attention, Tinlarebant reduces the formation of toxins which were implicated in STGD1 and dry AMD. Tinlarebant has been granted Fast Track Designation and Rare Pediatric Disease designation within the U.S., and Orphan Drug Designation within the U.S. and Europe for the therapy of STGD1.
Stargardt Disease
STGD1 is the commonest inherited retinal dystrophy (inflicting blurring or loss of central imaginative and prescient) in each adults and kids. The illness is brought on by a dysfunctional retina-specific gene (ABCA4) which ends up in huge accumulation of poisonous vitamin A byproducts (generally known as “bisretinoids”) within the retina resulting in retinal cell dying and progressive loss of central imaginative and prescient. The fluorescent properties of bisretinoids and the event of retinal imaging have helped ophthalmologists establish and monitor illness development. Importantly, STGD1 and dry AMD share the same pathophysiology which is characterised by the extreme accumulation of cytotoxic bisretinoids, retinal cell dying, and loss of imaginative and prescient. Vision loss happens slowly, regardless of peripheral growth of “dead retina”, till the illness reaches the middle of the attention (the macula).
Dry Age-related Macular Degeneration
Dry AMD is a number one trigger of imaginative and prescient loss within the U.S. and has no authorised remedies obtainable. There are an estimated 11 million dry AMD sufferers within the U.S. and over 196 million sufferers worldwide with an estimated world direct healthcare value of US$255 billion.
About Belite Bio
Belite Bio is a San Diego based mostly medical stage biopharmaceutical drug growth firm concentrating on at present untreatable eye ailments, equivalent to atrophic age-related macular degeneration (generally generally known as dry AMD) and STGD1, in
addition to particular metabolic ailments. For extra info, comply with us on Twitter, Instagram, LinkedIn, Facebook or go to us at www.belitebio.com.
Important Cautions Regarding Forward Looking Statements
This press launch accommodates forward-looking statements, together with statements concerning the potential implications of medical knowledge for sufferers, and Belite Bio’s development of, and anticipated preclinical actions, medical growth, regulatory milestones, and commercialization of its product candidates. Actual outcomes could differ materially from these indicated within the forward-looking statements in consequence of varied necessary elements, together with however not restricted to Belite Bio’s means to display the security and efficacy of its drug candidates; the medical outcomes for its drug candidates, which can not help additional growth or regulatory approval; the content material and timing of choices made by the related regulatory authorities concerning regulatory approval of Belite Bio’s drug candidates; the potential efficacy of Tinlarebant on the therapy of Dry AMD, in addition to these dangers extra absolutely mentioned within the “Risk Factors” part in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based mostly on info at present obtainable to Belite Bio, and Belite Bio undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not in consequence of new info, future occasions or in any other case, besides as could also be required by legislation.
Media and Investor Relations Contact:
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Tim McCarthy /[email protected]
