Tinlarebant is Belite Bio’s orally administered tablet intended to slow disease progression in subjects with Stargardt Disease and Geographic Atrophy in advanced Dry Age-related Macular Degeneration
Enrollment of GA subjects across multiple centers globally has begun in the third quarter 2023. (Credit: Bruno Henrique from Pixabay)
Belite Bio, Inc (NASDAQ: BLTE) (“Belite” or the “Company”), a clinical stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting retinal degenerative eye diseases which have significant unmet medical needs, today announced that, in its pivotal Phase 3 “PHOENIX” trial for subjects with GA, the first subject has been dosed at the Retina Associates of Southern California, a clinical trial site in the United States.
“We are pleased to have successfully dosed the first subject in the Phase 3 PHOENIX trial for GA. GA is a chronic, and progressive condition that ultimately leads to blindness. Predominantly affecting an elderly population, the unmet need remains high with no currently FDA-approved oral or non-invasive treatments for GA,” said Dr. Tom Lin, Belite’s Chairman and CEO. “The encouraging data in our Phase 2 trial for STGD1, which shares similar pathophysiology as GA, supports the potential for Tinlarebant to change the treatment paradigm for GA, as the first oral treatment that can reduce disease progression.”
Principal Investigator of the PHOENIX trial, Dr. Hani Salehi-Had, added, “The global PHOENIX trial plans to enroll GA patients with earlier-stage disease in an effort to prevent development of excessive retinal pathology and loss of vision. The continued trend of slowing expansion of autofluorescence and the reduction in incident atrophic retinal lesion growth rate with Tinlarebant in the ongoing Phase 2 STGD1 trial is encouraging and highlights Tinlarebant’s potential as a treatment for GA. We are excited to be the first US site to successfully enroll the first subject into the PHOENIX trial and look forward to potentially having this oral treatment approved by FDA for our GA patients with Dry AMD.”
Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, commented that, “Tinlarebant reduces formulation of toxic bisretinoids in the eye, but it does not interfere with the visual cycle. Its compelling safety profile seen up to 18-months in clinical trial is encouraging and supports the potential of Tinlarebant to be a much-needed and non-invasive treatment approach that can enable long-term dosing. Importantly, since Tinlarebant may be able to slow disease progression, there is also potential for Tinlarebant to treat across the disease spectrum, including intervening at earlier diseases stages such as intermediate AMD.”
Source: Company Press Release