Eisai, Biogen’s Alzheimer’s candidate shows promise in PhII trial

The firms say data show a statistically significant slowing in clinical decline and reduction of amyloid beta accumulated in the brain in patients taking the highest dose of the drug (10mg/kg biweekly) versus placebo.

Also, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS - which combines items from the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog), the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale and the Mini-Mental State Examination (MMSE) - as early as six months including at 12 months.

The drug’s tolerability profile was acceptable, the firms noted, the most common treatment emergent adverse events being infusion-related reactions and amyloid related imaging abnormalities (ARIA).

"This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis," said Lynn Kramer, chief clinical officer and chief medical officer, Neurology Business Group, Eisai.

"We will discuss these very encouraging results with regulatory authorities to determine the best path forward. We continue to work towards the goal of delivering BAN2401 to patients and healthcare professionals as early as possible."

"These BAN2401 18-month data offer important insights in the investigation of potential treatment options for patients with Alzheimer’s disease and underscores that neurodegenerative diseases may not be as intractable as they once seemed," added Alfred Sandrock, executive vice president and chief medical officer at Biogen.

The news follows a batch of recent high profile late-stage failures of experimental Alzheimer’s disease therapies, including AstraZeneca and Eli Lilly’s BACE inhibitor lanabecestat and Janssen’s atabecestat.

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