Novo Nordisk GLP-1 fails to slow Alzheimer's in two trials

An oral GLP-1 drug from Novo Nordisk failed to delay the progression of Alzheimer's disease in a pair of clinical trials, dealing a setback to the Danish drug giant's hopes of expanding the market for its semaglutide products.

Why it matters: The maker of Wegovy and Ozempic had said the studies were marked by low probability and huge potential. But the results underscored the limitations of GLP-1s and sent the company's stock falling in early trading on Monday.

Driving the news: Novo said that its oral semaglutide, Rybelsus, did not meet the primary goal of slowing down cognitive decline by 20% in a pair of late-stage trials the company ran over two years.

• However, the company said semaglutide did have an observable effect on unspecified biomarkers connected with Alzheimer's. The company is expected to elaborate on the results at a scientific conference next month.
• The randomized trials included more than 3,800 adults age 55 to 85 with early-stage Alzheimer's disease. Novo is canceling a year-long extension of the studies.

What they're saying: The Alzheimer's Association said the trial results will still help improve understanding of the disease and of GLP-1s prospects for slowing its progression.

• "Though this semaglutide pill did not help against Alzheimer's, the field will continue to investigate this class of drugs, as they may act differently," chief science officer Maria Carrillo said in a statement.
• The trial is part of the next wave of Alzheimer's research, focused on how to alter upstream causes of the disease, said said Howard Fillit, chief science officer at the Alzheimer's Drug Discovery Foundation.
• "It's really exciting that we've entered into a new era where a whole multitude of drugs will be tested in Alzheimer's disease along many, many pathways that are related ... to the biology of aging," he said.

Between the lines: The results still marked another setback for Novo, which has been losing market share in GLP-1s to rival Eli Lilly. Shares in the company fell more than 12% on the news Monday morning, but recovered slightly and closed down 5.6%.

• "We always knew that there would be low likelihood of success, but it was important to determine if semaglutide could take [on] one of the medicine's most challenging frontiers based on the indicative data points we had," CEO Mike Doustdar said in a video posted to LinkedIn.

Editor's note: The story has been updated to reflect Novo Nordisk's shares were down 5.6% at Monday's market close (not 5.8%).