Belite Bio (Lin BioScience’s subsidiary), a clinical stage drug development company targeting untreatable conditions in ophthalmology and metabolic diseases, announced today that the UK National Institute for Health Research (NIHR) acknowledges LBS-008’s potential in treating dry age-related macular degeneration (dry AMD) and Stargardt Disease (STGD). NIHR has conducted a systematic review of 7,948 articles on treatments for dry AMD and STGD and recently published their findings. The report recommended further studies with fenretinide in both dry AMD and STGD as they consider it a treatment with a promising mechanism of action. The NIHR also acknowledges LBS-008 as a treatment with the same mechanism of action, reducing RBP4 to prevent the accumulation of A2E and lipofuscin.
“Following the inclusion of LBS-008 in the US NIH’s “Translational Research Success Stories”, LBS-008 and it’s mechanism of action have received significant attention from NIHR, the top healthcare authority in the UK. “This is very encouraging for our ongoing clinical trials.” stated Dr. Tom Lin, CEO of Belite Bio. “We look forward to receiving our interim Phase I clinical trial results mid 2019.”
LBS-008 is a first-in-class drug with an RBP4 inhibiting mechanism. Despite this, clinical proof-of-concept has been established in fenretinide’s Phase 2b study in dry AMD. In this study, fenretinide treatment produced a dose-dependent reduction in serum RBP4 that was associated with reduced lesion growth rates in dry AMD patients with geographic atrophy when those patients achieved serum RBP4 levels below 1 uM. As fenretinide has a relatively poor ability to lower RBP4, only a subset of patients achieved this level of RBP4 at the highest fenretinide dose.
LBS-008 is expected to have superior RBP4 lowering compared to fenretinide and to achieve RBP4 lowering below 1 uM in a majority of patients. Belite Bio’s ongoing Phase 1 study will ensure selection of an optimal dose of LBS-008 that reduces RBP4 to below the target concentration in all or most patients.
LBS-008 targets and reduces RBP4 (the primary carrier of vitamin A) levels in circulation through convenient oral dosing. LBS-008 dose not target or interrupt the visual cycle, instead, it reduces the load of vitamin A (a precursor to the toxic bisretinoid A2E) entering the visual cycle but not the rate of the visual cycle. This will minimize side-effects from direct inhibition of the visual cycle.
About Belite Bio
Belite Bio (Lin BioScience’s subsidiary) is a clinical stage drug development company targeting untreatable diseases. Our therapeutic pipeline, which includes a novel RBP4 platform technology and two first-in-class candidates, is focused on meeting the unmet needs of patients suffering from macular degeneration, liver disease and diabetes.