By Deena Beasley
SAN DIEGO, Dec 2 (Reuters) – Novo Nordisk in 2020 launched pivotal trials of its GLP-1 drug semaglutide in Alzheimer’s patients based on studies in humans, animals and real-world findings, a top company executive said on Tuesday, acknowledging criticism that Novo’s studies had design flaws.
Although the trials failed to show a statistically significant reduction in cognitive decline in patients given the drug, “we still think it was the right decision…a scientific question that needed an answer,” said Peter Johannsen, Novo’s international medical vice president, in an address at the Alzheimer’s Disease Clinical Trials meeting in San Diego.
Data, now consolidated on Novo’s website, had shown evidence that the GLP-1 hormone is involved in neurotransmission, with multiple effects throughout the brain, he said.
While Alzheimer’s is defined by the presence of toxic amyloid plaques in the brain, “there are still things we don’t know” about the pathology of the disease, Johannsen said. “This is a very complex disease with a lot of things going on with different genetic signatures.”
Novo is expected to present on Wednesday initial results from two two-year studies that tested Novo’s GLP-1 diabetes pill Rybelsus against a placebo in nearly 4,000 Alzheimer’s patients.
The full results will be presented at a different medical meeting in March. The company issued a brief press release last week saying the studies did not meet their objectives.
COGNITIVE BENEFITS IN DIABETES PATIENTS
Johannsen said retrospective studies have shown cognitive benefits for diabetes patients using GLP-1s, which were first approved for blood sugar control, with gains seen after about a year of treatment, and building with long-term use.
Some of those analyzes did not specify what type of dementia a patient developed. Some of the real-world evidence was based on clinical diagnosis of Alzheimer’s rather than more precise testing and identification of amyloid plaques.
About 60% of people with dementia have Alzheimer’s, according to the Alzheimer’s Association, with the remaining cases caused by vascular or other issues.
Johannsen noted potential “biases” in real-world analysis. He said that diabetes patients prescribed GLP-1 were more likely to have access to endocrinologists, rather than just primary care, and may be in higher socioeconomic groups than the general population.
Patients on GLP-1s for diabetes probably have better glycemic and metabolic control than those not on the treatments, he said, possibly delaying them from seeking further help and being diagnosed with dementia.
(Reporting by Deena Beasley Editing by Bill Berkrot)