While biopharma saw a big setback in Alzheimer’s disease research this past week—with the late-stage clinical failure of Biogen and Eisai’s aducanumab—medical device manufacturer Neuronix ran into efficacy obstacles of its own, except in front of the FDA.
An agency advisory panel voted 14 to 0 against recommending a de novo clearance for the Israeli company’s transcranial magnetic stimulation device, the neuroAD system, which targets the areas of the brain associated with memory and learning. The noninvasive daily therapy is delivered while patients complete cognitive training sessions using a computer touchscreen.
While some members expressed hope for the therapy in the future, the panel followed the concerns voiced by FDA reviewers—namely, that the company’s pivotal clinical study showed a sham treatment outperforming Neuronix’s device in cognition assessment scores after seven weeks.
The agency was also uncertain about the study’s methodology and post-hoc analyses, which pooled clinical data from inside and outside the U.S., according to its briefing document (PDF) for the committee panel.
“We are pleased that the committee recognized the safety of the device, but we are disappointed that the panel's feedback on our clinical studies and data analysis may result in neuroAD not being available in the U.S. in the foreseeable future,” Neuronix President and CEO Eyal Baror said in a statement after the meeting.
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“We plan to engage with the FDA to discuss a path forward to ensure that U.S. patients have the same access to this treatment as is enjoyed by Alzheimer's sufferers in over 30 other countries," he added. The neuroAD system has received a CE mark and is available across Europe, Australia and Israel, and was granted FDA review under the expedited access pathway.
Meanwhile, Biogen and Eisai’s amyloid-targeting monoclonal antibody saw two phase 3 trials terminated early for futility, following an analysis from an independent data monitoring committee.
A full breakdown was not available, but the primary data showed monthly doses of aducanumab were not going to beat out placebo in cognitive and functional impairment measures by the 18-month analysis.
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"On a day when yet another Alzheimer's drug trial was curtailed, we believe that this device offers a safe and effective nonpharmacologic solution to patients in need and are appreciative that the committee saw our data as a positive signal toward next steps," Baror said.