AsianScientist (Dec. 2, 2016) – Eisai Co., Ltd. has announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of the beta secretase cleaving enzyme (BACE) inhibitor E2609.
The inhibitor was discovered by Eisai and is jointly developed by Eisai and Biogen Inc. E2609 is currently being investigated in Phase III clinical studies for early Alzheimer’s disease. The news of this fast track approval is a bright spot in Alzheimer’s research, which has recently faced a major setback in the failure of Eli Lily’s amyloid-targeting solanezumab in a Phase III trial.
Fast Track is a process designed to facilitate the development and review of drugs to treat serious conditions and tackle key unmet medical needs by allowing for frequent interactions with the FDA. It may also enable Priority Review by the FDA if supported by clinical data at the time of New Drug Application submission.
Discovered in-house by Eisai, E2609 is an investigational next-generation oral candidate for the treatment of Alzheimer’s disease that is believed to inhibit BACE, a key enzyme in the production of amyloid beta (Aβ), a hallmark of Alzheimers.
By inhibiting BACE, E2609 may decrease the formation of toxic Aβ peptide aggregates and amyloid plaques in the brain, thereby potentially slowing disease progression. The first Phase III study for E2609 in the clinical trial program called MISSION AD began in October 2016 and will enroll 1,330 patients with biomarkers confirmed for early Alzheimer’s disease.
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Source: Eisai Co. Ltd.; Photo: Shutterstock.
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