Initiation Of Phase III Clinical Trial Of BAN2401 In Early Alzheimer's Disease


In Thursday's note, he said he and his team already had "many concerns regarding beta amyloid as a target following the failures of multiple other antibodies in recent years". Yet Eisai remains confident in its continued development.

Clarity AD will enroll 1,566 patients with mild cognitive impairment due to AD or mild AD dementia with confirmed amyloid pathology in the brain. After discussion with regulatory agencies based on the results of a Phase II clinical study (Study 201), a single Phase III clinical study is being initiated to support a filing for BAN2401. "But as for treatment for patients living with the disease now, this one hurts". The primary endpoint is the change from baseline in a scale called CDR-SB at month 18.

[Notes to editors] 1.

Studies have shown that amyloid plaques don't necessarily correlate with severity of Alzheimer's symptoms in humans, and some researchers hold that by the time amyloid plaques actually appear, the brain is already too damaged for anti-amyloid drugs to be useful.

Global drugmakers such as Lilly have been developing treatments on such a hypothesis, but all have failed.

Biogen BIIB, -29.02% and drug development partner Eisai Co.

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BAN2401 has been seen as something of an also-ran in the Biogen/Eisai pipeline, particularly after reporting confusing results in a phase 2b trial previous year.

Five of the presentations will be given for BAN2401 and elenbecestat. Patients who received treatment with BAN2401 were randomized to five dose regimens, 2.5 mg/kg biweekly (52 patients), 5 mg/kg monthly (51 patients), 5 mg/kg biweekly (92 patients), 10 mg/kg monthly (253 patients), or 10 mg/kg biweekly (161 patients).

Experts had seen aducanumab as one of the last tests of the hypothesis that removing sticky deposits of amyloid from the brain of patients in earlier stages of the lethal disease could stave off its ravages, which include loss of memory and the ability to care for oneself.

Biogen plans to disclose the detailed outcomes of ENGAGE and EMERGE studies at an academic meeting in the future. Currently, an open-label extension phase of Study 201 is ongoing. The company also develops a potential treatment for Complete Spinal Cord Injury.

Eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 30 years of experience of drug discovery activities in the area of Alzheimer's disease/dementia. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential.