Policy & Regulation
Belite Bio wins US FDA approval for LBS-008 IND for macular degeneration and Stargardt disease
25 April 2019 -

Drug development company Belite Bio reported on Wednesday the receipt of US Food and Drug Administration (FDA) approval for its Investigational New Drug application (IND) for LBS-008 for the treatment of atrophic Age-related Macular Degeneration (dry AMD) and Stargardt disease, an inherited juvenile form of macular degeneration.

LBS-008 (BPN-14967) is one of the first drugs to graduate from the US National Institute of Health's (NIH) Blueprint Neurotherapeutics Network Program, which will continue to fund LBS-008's discovery and development as well as provide support until the completion of its Phase 1 single ascending dose (SAD) clinical trial.

According to the company, it holds the worldwide exclusive rights for LBS-008, a first-in-class oral therapy that prevents the buildup of toxins (A2E) in the eye that cause Stargardt disease and contribute to atrophic Age-related Macular Degeneration (dry AMD).

LBS-008 received US and EU orphan drug designation (ODD) in 2017 and 2018 and rare paediatric disease designation (RPD) from the US FDA in 2018 for the treatment of Stargardt disease.

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