Novo stays in the Alzheimer’s race despite failed pill trial

Novo Nordisk signaled continued interest in Alzheimer’s research after two studies of its oral semaglutide medicine showed no cognitive benefit but revealed limited biological activity.

The findings were presented at the Clinical Trials on Alzheimer’s Disease conference in San Diego. The company reported small reductions of 10% or less in several cerebrospinal-fluid markers tied to neurodegeneration, inflammation and tau. Most of the 30 biomarkers analyzed showed no change.

Novo said last month that Rybelsus, the pill form of semaglutide, did not slow Alzheimer’s progression in two late-stage trials. More than 3,500 patients took part. The program was an attempt to extend semaglutide’s reach beyond its current uses in obesity, diabetes and related conditions.

Peter Johannsen, international medical vice president for clinical drug development, said the biomarker shifts indicate a biological effect even without measurable cognitive gains. He said the company is continuing to review the data and has not decided on next steps.

Johannsen noted that the results were similar to those produced by gantenerumab, a Roche candidate that failed in clinical testing. Approved Alzheimer’s drugs have shown biomarker changes closer to 30%, he said.

Novo began planning the Alzheimer’s effort in late 2020 after two years of reviewing research in the field. Johannsen told the conference that the company still considers the move justified. He said the trials addressed a scientific question, though the outcome fell short of expectations.

He also described potential biases in real-world evidence involving GLP-1 medicines. Patients starting a new and potent therapy may have higher income, better access to care or physicians more familiar with emerging treatments. People in the early stages of Alzheimer’s may be less likely to pursue intensive diabetes management than healthier peers, he said.

Novo has not indicated whether it will conduct further studies of semaglutide in Alzheimer’s, but the company said the data will continue to be examined.