Biopharmaceutical firm Belite Bio has received the US Food and Drug Administration (FDA) approval to conduct a Phase I clinical trial of LBS-008 (BPN-14967) to treat dry macular degeneration and Stargardt disease.

LBS-008 is an oral therapeutic designed to prevent the accumulation of toxins (A2E), which are by-products of vitamin A and cause progressive retinal cell death and permanent vision loss.

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The therapy minimises and regulates the retinol-binding protein 4 (RBP4) that carries vitamin A to the eye. Belite Bio noted that LBS-008 does not directly affect the visual cycle of the eye.

“We’re encouraged by the ongoing favourable regulatory view of our technology, including a recent systematic review published by the UK National Institute for Health Research.”

LBS-008 secured orphan drug designation (ODD) in the US and EU in 2017 and 2018, respectively. It also has rare paediatric disease designation in the US for Stargardt disease.

The development of the therapy has been funded the US National Institute of Health (NIH) Blueprint Neurotherapeutics Network (Blueprint Program), which will also support the Phase I single ascending dose trial.

Belite Bio chairman Tom Lin said: “We’re encouraged by the ongoing favourable regulatory view of our technology, including a recent systematic review published by the UK National Institute for Health Research identifying the reduction of serum RBP4 as the most promising treatments for dry AMD and Stargardt disease.

“We plan to continue to work closely with our collaborators and leverage the Blueprint Program’s resources and support to move LBS-008 to the next clinical and regulatory milestone.”

Dry macular degeneration, a primary cause of vision loss in the US, currently lacks approved therapies.

Stargardt disease is an inherited juvenile type of macular degeneration, which leads to progressive vision loss beginning in childhood. The majority of patients become visually impaired by the age of 20.