Biogen reports positive interim Phase Ib results of aducanumab to treat Alzheimer’s disease

The ongoing Phase Ib randomized, double-blind, placebo-controlled, multiple-dose PRIME trial is evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of aducanumab.

The interim analysis of PRIME reflects data for 166 patients, up to week 54 in the placebo, 1mg/kg, 3mg/kg and 10mg/kg dose arms, and up to week 30 data for the 6mg/kg dose arm.

In the trial, aducanumab showed an acceptable safety profile and positive results on radiologic and clinical measurements in these patients.

The company said that treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque, which is believed to play a major role in the development of the symptoms of AD.

The effect of aducanumab on AD-related impairment was measured using the Mini Mental State Examination (MMSE) and Clinical Dementia Rating sum of boxes (CDR-SB).

The MMSE is used to measure a patient’s cognitive status, while the CDR-SB characterises a patient’s cognitive and functional performance.

Biogen Idec group senior vice-president and chief medical officer Dr Alfred Sandrock said: "This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease.

"Based on these results, we are advancing the aducanumab clinical program to Phase III with plans to initiate enrollment later this year."

Aducanumab is selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM).

The company licensed aducanumab from Neurimmune under a collaborative development and license agreement.