Eisai receives clearance for phase III trials of Alzheimer’s disease drug

Eisai will commence phase III trials of its novel investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 after receiving US regulatory approval.

The US Food and Drug Administration has confirmed there was sufficient data to support the advancement of E2609 to phase III testing, based on the clinical and preclinical data generated on the treatment so far.

Additionally, the regulator approved the outlines of Eisai's plan to launch two studies with placebo-controlled designs among patients with early Alzheimer's disease, where the treatment group will be administered a dosage of 50 mg a day of E2609 and outcomes assessed at 24 months.

Eisai and Biogen, the co-developer of the drug, intend to conduct similar discussions with regulatory authorities in Japan and the EU, with the aim of conducting this study as a global multi-centre research programme.

Dr Lynn Kramer, chief clinical officer and chief medical officer of Eisai's neurology business group, said: "We believe that the phase III clinical study design outline agreed upon will enable us to efficiently conduct studies on BACE inhibitors aimed at realizing preemptive medicine, and will accelerate the development of E2609."

In Study 202, a previous phase II trial of E2609, the drug was shown to deliver a favourable safety performance across all doses.

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