Btobioinnovation.com
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation jcm9144@gmail.com
SPECIAL REPORT #14
Bad News for Alzheimer’s Patients
Within two days, the biopharmaceutical industry had to cope with two setbacks for the treatment of Alzheimer’s disease.
On March 21, Biogen and partner Eisai announced the failure of the late-stage clinical trial of aducanumab, an amyloid-targeting monoclonal antibody, and the next day, Neuronix, a medical device manufacturer, saw the US FDA advisory committee voting a 14 to 0 against the approval of its NeuroAD system, a transcranial magnetic stimulating device.
The adacunumab phase 3 program, with patients in early stage of Alzheimer’s disease, was terminated by Biogen and Eisai based on a recommendation from the data-monitoring committee which found it unlikely that the primary endpoint would be met at the 18-month analysis. Biogen’s shares plunged by almost 30% the day of the announcement and saw its market value decrease by $18 billion. Earlier this week Biogen announced a $5 billion buyback plan to persuade its shareholders to still support the company. The theory of targeting misfolded beta amyloid protein to cure or even delay Alzheimer’s disease has never been validated in a late-stage clinical setting. In spite of this new failure, Eisai and Biogen have started a phase 3 study with BAN2401, a beta amyloid antibody which has a different mode of action than adacunumab. According to our own records the Biogen/Eisai’s setback of adacunumab is the 17th phase 3 failure of an Alzheimer’s disease investigational drug in the last 9 years.
Neuronix, an Israeli based company, has developed NeuroAd, which targets areas of the brain associated with memory and learning trough transcranial magnetic stimulation. The noninvasive daily therapy is delivered while patients complete cognitive training sessions through a computer touchscreen. The US FDA advisory panel expressed concerns about efficacy of the device and was uncertain about the study’s methodology and post-hoc analysis which pooled data from different protocols from inside and outside the US. The NeuroAD system, which had been granted an expedited pathway by the FDA, has received CE mark and is already available in over 30 countries including Europe, Australia and Israel.
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