Drug development company, Belite Bio’s Investigational New Drug application for LBS-008 (BPN-14967), developed to treat AMD and Stargardt disease, has reportedly been approved by the U.S. Food and Drug Administration. 

As per trusted sources, Belite Bio’s new drug is the first to graduate from the US National Institute of Health’s Blueprint Neurotherapeutics Network, which has invested toward LBS-008's discovery and development and will continue to offer support and investment until the conclusion of its Phase 1 clinical trial. 

Dr. Konstantin Petrukhin, Columbia University Medical Center’s Associate Professor of Ophthalmic Science and inventor of the technology stated that the commencement of the Phase 1 trial is a significant milestone for LBS-008, which was sponsored by the NIH Blueprint Program right from lead optimization to preclinical proof of concept. The drug is anticipated to bring hope to a lot of patients affected by incurable forms of macular degeneration, Dr. Petrukhin added.

Dr. Tom Lin, Chairman of Belite Bio, said in a statement that the company is thrilled to announce the start of Phase 1 clinical trial of LBS-008 in the US in conjunction with the NIH.

The current favorable regulatory view of its technology has encouraged the company, as well as the systematic analysis published by the UK National Institute for Health Research, recognizing reduction of RBP4 as the most lucrative treatments for dry AMD and Stargardt disease, added Dr. Lin.

The company plans to continue working closely with its collaborators until the next clinical and regulatory milestone, Dr. Lin said.

For the record, LBS-008 is a treatment dedicated to preventing toxin build up in the eye that leads to severe conditions like atrophic dry AMD and Stargardt disease. The drug development company Belite Bio owns exclusive global rights for LBS-008. The drug had received orphan drug designation (ODD) in the US & EU, and a rare pediatric disease designation from the FDA for treating patients with Stargardt disease, reported sources.  

Source Credits: https://www.biospace.com/article/releases/belite-bio-announces-fda-approval-of-investigational-new-drug-ind-for-phase-1-clinical-trial-of-lbs-008-to-treat-macular-degeneration-and-stargardt-disease/