- LBS-008 (aka Tinlarebant) is Belite Bio’s orally administered pill for early intervention to take care of the well being of retinal tissue in Stargardt illness (STGD1) and Dry AMD sufferers
- A 2-year Phase 2 trial in adolescent STGD1 and a worldwide Phase 3 trial in adolescent STGD1 are ongoing
- The Phase 3 trial 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 has commenced within the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia, with a number of sufferers already enrolled
- LBS-008, Belite Bio’s lead asset, has been granted Fast Track Designation and Rare Pediatric Disease Designation within the U.S., and Orphan Drug Designation in each the U.S. and Europe for STGD1
SAN DIEGO, Sept. 16, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE), a San Diego based mostly scientific stage biopharmaceutical drug improvement firm focusing on presently untreatable eye ailments, at the moment introduced the approval from the National Medical Products Administration (NMPA) of China to provoke the Phase 3 scientific trial of LBS-008 in adolescent STGD1 in China.
“We are very pleased with our clinical trial progress and excited to start the DRAGON clinical trial in China to bring this potential treatment to patients afflicted with STGD1.” stated Dr. Tom Lin, Belite Bio’s Chairman and CEO. “With a 1 in 10,000 prevalence rate, STGD1 is the most common inherited retinal dystrophy causing blurring and/or loss of central vision in both adults and children with no approved treatment. We have an early intervention, orally administered treatment which has the potential to maintain the health of retinal tissues and address a large unmet need.”
Belite Bio’s DRAGON trial is a 2-year Phase 2 trial and a 2-year Phase 3 trial of LBS-008 in adolescent STGD1 topics which is presently underway. The Phase 2 trial has enrolled a complete of 13 topics at scientific websites in Australia and Taiwan. Preliminary knowledge from the Phase 2 trial on the first 6-month interval exhibits that 8 of the 13 sufferers (or 61.5%) recorded a acquire in best-corrected visible acuity (BCVA) in not less than one eye, together with 2 sufferers who recorded a BCVA acquire in each eyes.
In addition, there have been no atrophic lesions in any of the 13 topics at research begin and just one topic confirmed proof of a retinal lesion (~0.3mm2 in dimension) at 6-months. Belite expects the subsequent knowledge readout of this Phase 2 trial to happen within the final quarter of 2022 when all topics have accomplished 12 months of remedy.
The DRAGON trial is a section 3, randomized, double-masked, placebo-controlled, international and multi-center research, designed to judge the security and efficacy of LBS-008 in adolescent STGD1 sufferers. To date, the Company has commenced the DRAGON trial within the U.S., the United Kingdom, Germany, Belgium, Switzerland, Hong Kong, Taiwan, and Australia. Approximately 60 sufferers are focused for enrollment on this research with a 2:1 randomization (energetic:placebo). (For extra data, go to clinicaltrials.gov at https://www.clinicaltrials.gov/ct2/show/NCT05244304?term=belite+bio&draw=2&rank=1)
The accumulation of poisonous bisretinoids have additionally been implicated within the development of Dry AMD, a illness with an enormous unmet want, which primarily impacts the aged and exhibits a pathophysiology that’s just like that of STGD1. This discovering has led to the sponsorship and endorsement of LBS-008 by the NIH Blueprint program as a promising first-in-class oral remedy to gradual or halt the development of Dry AMD. Belite believes that LBS-008 has the potential to be an efficient early intervention remedy to take care of the well being of retinal tissues in Dry AMD. Belite plans to provoke a Phase 2/3 scientific trial for Dry AMD within the fourth quarter of 2022.
About LBS-008
LBS-008 is a novel oral remedy supposed as an early intervention to stop the buildup of toxins within the eye that trigger STGD1 and contribute to Dry AMD. These toxins are by-products of vitamin A within the visible cycle, which depends on the availability of vitamin A (retinol) to the attention. LBS-008 works by lowering and sustaining ranges of serum retinol binding protein 4 (RBP4), the only real provider protein for transport of retinol into the attention. By modulating the quantity of retinol coming into the attention, LBS-008 reduces the formation of vitamin A-based toxins which have been implicated in STGD1 and Dry AMD with a purpose to keep the well being of retinal tissues. LBS-008 has been granted Fast Track Designation, Rare Pediatric Disease Designation within the U.S., and Orphan Drug Designation within the U.S. and Europe for the remedy 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 large accumulation of poisonous vitamin A byproducts (referred to 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 determine and monitor illness development. STGD1 and Dry AMD share the same pathophysiology characterised by 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. There aren’t any accredited therapies out there for Dry AMD. There are an estimated 11 million Dry AMD sufferers within the U.S. and over 196 million sufferers worldwide with an estimated international direct healthcare price of US$255 billion.
About Belite Bio
Belite Bio is a San Diego based mostly scientific stage biopharmaceutical drug improvement firm focusing on presently untreatable eye ailments, akin to atrophic age-related macular degeneration (generally referred to as superior Dry AMD) and Stargardt illness, and metabolic ailments. For extra data, 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 incorporates forward-looking statements, together with statements relating to the potential implications of scientific knowledge for sufferers, and Belite Bio’s development of, and anticipated preclinical actions, scientific improvement, regulatory milestones, and commercialization of its product candidates. Actual outcomes might differ materially from these indicated within the forward-looking statements consequently of varied necessary elements, together with however not restricted to Belite Bio’s capability to show the security and efficacy of its drug candidates; the scientific outcomes for its drug candidates, which can not assist additional improvement or regulatory approval; the content material and timing of choices made by the related regulatory authorities relating to regulatory approval of Belite Bio’s drug candidates; the potential efficacy of LBS-008 on the remedy of Dry AMD, in addition to these dangers extra totally 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 data presently out there to Belite Bio, and Belite Bio undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not consequently of new data, future occasions or in any other case, besides as could also be required by legislation.
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