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news.Acucela has filed an investigational new drug application to conduct a Phase I clinical trial for its lead compound ACU-02 with the FDA.
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Acucela plans to initiate dosing of healthy normal volunteers in a double-masked, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of ACU-02 before the end of the second quarter of 2008.
ACU-02 is an orally available small molecule modulator of the visual cycle, which is thought to play a key role in the pathophysiology of the dry form of age-related macular degeneration (AMD), a disease which afflicts over 29 million patients worldwide.
Ryo Kubota, Acucela’s CEO, said: “Given the fact that ACU-02 is a non-retinoid compound, we believe that it will have a better side effect profile, and additionally, this product candidate is delivered orally – an administration method which we believe would be popular with patients given that current AMD treatments are delivered by injection.”