Biogen on go with Alzheimer’s drug

A new analysis of a larger dataset has borne fruit for Biogen (NASDAQ:BIIB) and its Alzheimer’s disease candidate aducanumab. The terminated Phase 3 EMERGE study met the primary endpoint showing a statistically significant reduction in clinical decline at week 78 as measured by a scale called CDR-SB driven primarily by greater exposure to high-dose aducanumab. Specifically, patients in the treatment group experienced a 23% reduction in clinical decline versus placebo (p=0.01).

The company believes that a subset of patients in the also-terminated Phase 3 ENGAGE study support the findings from EMERGE.

As a result, it plans to file a U.S. marketing application next quarter based on consultations with the FDA and the analysis of the expanded dataset from the two studies, discontinued in March after a futility analysis showed that both were unlikely to meet the primary endpoints. After the studies were stopped, additional data became available based on a total of 3,285 patients, 2,066 of whom completed 18 months of treatment.

This is the first time that the clearance of aggregated amyloid beta demonstrated a reduction in clinical decline according to principal investigator Dr. Anton Porsteinsson.

Management will host a conference call this morning at 8:00 ET to discuss the new analysis.

The company is co-developing the monoclonal antibody with Eisai (OTCPK:ESALY).

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