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Novo Nordisk won’t add Alzheimer’s disease to the list of conditions its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy, can treat, despite high hopes and two years of study.
The Danish drugmaker recently said that in two large studies, semaglutide, the active ingredient in its drugs, failed to slow cognitive decline in thousands of people with early stages of the mind-robbing disease.
Novo’s trial was anticipated for clues to whether GLP-1 drugs, used by millions for diabetes and weight loss, might slow progression of a disease that afflicts more than 7 million Americans. Instead, Alzheimer’s researchers are anticipating Novo’s release of key details about the late-stage studies at an Alzheimer’s scientific conference in San Diego in early December. They hope to sift through the data to see whether it provides any biological clues for future Alzheimer’s research.
“I’m really interested to see the results of those biomarker findings and other details of the study,” said Dr. Eric Reiman, executive director of Banner Alzheimer’s Institute in Phoenix.
What did the study find?
Novo Nordisk tested an older pill version of semaglutide previously approved for Type 2 diabetes. Novo’s blockbusters Ozempic and Wegovy are injectables that also contain semaglutide. Novo is seeking Food and Drug Administration approval of a Wegovy pill, called orforglipron, for obesity.
The two trials enrolled more than 3,800 adults with early stage Alzheimer’s disease and randomly assigned them to groups that received a semaglutide pill or a placebo and standard care. While the group that received semaglutide improved disease-related biomarkers, the medication didn’t delay progression of the disease, Novo said.
Novo decided to study semaglutide as a potential Alzheimer’s treatment due to evidence in other studies, pre-clinical models and results from diabetes and obesity studies.
The setback dashes hopes for Novo that Alzheimer’s could open a major new market for GLP-1 medicines. A positive trial result could have put Novo ahead of rival Eli Lilly, against which it has lost ground in its core treatment areas of obesity and diabetes.
“The fact that the study was discontinued after two years, despite a planned third-year extension, suggests that semaglutide offers virtually no benefit in slowing Alzheimer’s progression,” Erik Berg-Johnsen, portfolio manager at Novo shareholder Storebrand Asset Management, told Reuters.
Alzheimer’s researchers look for clues
The study result are “disappointing” but “show a fundamental shift in how we approach the development of new Alzheimer’s treatments,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation.
For decades, Alzheimer’s researchers targeted amyloid-beta, a protein that accumulates and forms plaques in the brains of Alzheimer’s patients. The semaglutide trial shows Alzheimer’s research is “expanding beyond amyloid to target the complete pathobiology of the disease,” said Fillit.
A Novo spokesperson said the company is ending studies of semaglutide as a treatment for Alzheimer’s. Novo will unveil more details of its semaglutide studies at a scientific conference, Clinical Trials on Alzheimer’s Disease, in San Diego, Dec. 1-4.
Those results might “suggest a path forward for semaglutide as part of a combination therapy approach,” Fillit said.
Novo’s report provides immediate clarity for doctors who prescribe semaglutide, because patients often want to know whether the medication can slow cognitive decline, experts said.
“That question has been coming up a lot with patients about the potential benefits and risks,” Reiman said.
Reiman said researchers will look for more clues when Novo releases more study data at the CTAD conference.
He said that semaglutide was tested on individuals who already are experiencing Alzheimer’s symptoms. Reiman, co-director of the Alzheimer’s Prevention Initiative, is among researchers who’ve called for studying whether treating Alzheimer’s patients earlier can delay memory and thinking problems.
“My own guess has been that if it (semaglutide) were to be effective, it would be more effective in unimpaired individuals,” before Alzheimer’s is extensive, Reiman said.
Contributing: Reuters