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Belite Bio Announces Late-Breaking Presentation at the American Academy of Ophthalmology 2022 Annual Meeting

Last Updated on September 23, 2022 by GlobeNewsWire

1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 to be presented

SAN DIEGO, Sept. 23, 2022 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE), a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, today announced that the 1-year interim data from the 2-year Phase 1b/2 trial of LBS-008 in adolescent STGD1 will be presented at the “Late Breaking Development” session at the American Academy of Ophthalmology Annual Meeting (AAO 2022) being held September 30 – October 3, 2022 in Chicago.

Details of the presentation are as follows:

Title: A 2-year Phase 1b/2 Study of the Safety and Tolerability of Tinlarebant in Adolescent STGD1 Subjects: Interim FindingsAbstract Number: 30071744Section: Section X, Late Breaking Developments, Part II Date and Time: Saturday, Oct 1, 2022 – 9:20 AM – 9:25 AM (Central Daylight Time)Location: McCormick Place – Arie Crown, ChicagoPresenting Author: John Grigg, MBBS

For more information about the AAO 2022 annual meeting please visit: https://www.aao.org/annual-meeting.

About LBS-008

LBS-008 is a novel oral therapy intended as an early intervention to prevent the buildup of toxins in the eye that cause STGD1 and contribute to Dry AMD. These toxins are by-products of vitamin A in the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. LBS-008 works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for transport of retinol into the eye. By modulating the amount of retinol entering the eye, LBS-008 reduces the formation of vitamin A-based toxins which have been implicated in STGD1 and Dry AMD in order to maintain the health of retinal tissues. LBS-008 has been granted Fast Track Designation, Rare Pediatric Disease Designation in the U.S., and Orphan Drug Designation in the U.S. and Europe for the treatment of STGD1.

Stargardt Disease

STGD1 is the most common inherited retinal dystrophy (causing blurring or loss of central vision) in both adults and children. The disease is caused by a dysfunctional retina-specific gene (ABCA4) which results in massive accumulation of toxic vitamin A byproducts (known as ‘bisretinoids’) in the retina leading to retinal cell death and progressive loss of central vision. The fluorescent properties of bisretinoids and the development of retinal imaging have helped ophthalmologists identify and monitor disease progression. STGD1 and Dry AMD share a similar pathophysiology characterized by excessive accumulation of cytotoxic bisretinoids, retinal cell death, and loss of vision. Vision loss occurs slowly, despite peripheral expansion of ‘dead retina’, until the disease reaches the center of the eye (the macula).

About Belite Bio

Belite Bio is a San Diego based clinical stage biopharmaceutical drug development company targeting currently untreatable eye diseases, such as atrophic age-related macular degeneration (commonly known as advanced Dry AMD) and Stargardt disease, and metabolic diseases. For more information, follow us on Twitter, Instagram, LinkedIn, Facebook or visit us at www.belitebio.com.

Important Cautions Regarding Forward Looking StatementsThis press release contains forward-looking statements, including statements regarding the potential implications of clinical data for patients, and Belite Bio’s advancement of, and anticipated preclinical activities, clinical development, regulatory milestones, and commercialization of its product candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; the potential efficacy of LBS-008 on the treatment of Dry AMD, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Media and Investor Relations Contact:Jennifer Wu /ir@belitebio.comTim McCarthy /tim@lifesciadvisors.com




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