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Novo Nordisk launches late-stage study in Alzheimer’s disease

Study will evaluate oral semaglutide in neurodegenerative disease

Novo Nordisk is planning to enter a late-stage development programme with the launch of a phase 3a study of oral semaglutide in Alzheimer’s disease next year.

The late-stage programme will involve around 3,700 people with early Alzheimer’s disease, with a planned launch in the first half of 2021.

The study will investigate and evaluate the efficacy and safety of once-daily oral semaglutide compared to placebo in Alzheimer’s, with an expected main treatment period in the trials of around two years.

Novo Nordisk markets oral semaglutide as Ryblesus in the US as an adjunct to diet and exercise to improve glycaemic control in type 2 diabetes patients.

Semaglutide binds to and activate the glucagon-like peptide-1 (GLP-1) receptor to increase insulin secretion in type 2 diabetes patients.

In animal studies, the effects of GLP-1 relevant for Alzheimer's included improved memory function and reduced phospho-tau accumulation, according to Novo Nordisk.

Novo Nordisk added that semaglutide has been shown to reduce measures of neuro-inflammation, which may affect cognition and function in Alzheimer’s patients.

Also, in post-hoc analysis of data from three large cardiovascular outcomes trials conducted by Novo Nordisk, which included 15,820 patients with type 2 diabetes and a median follow-up of 3.6 years, a total number of 47 people were identified with development of dementia, of which 32 were on placebo and 15 on GLP-1 (liraglutide or semaglutide).

This reflects that the rate of developing dementia was statistically significantly reduced by 53% in favour of GLP-1.

“As a company we aspire to address high unmet medical needs within serious chronic diseases, and we are therefore pleased to initiate phase 3 development of semaglutide within Alzheimer’s disease,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer at Novo Nordisk.

“Alzheimer’s disease has been an area of extensive research in the past decades, unfortunately without any major medical breakthroughs. Due to the growing unmet medical need and the increasing evidence of a potential therapeutic role for GLP-1, we will investigate the benefits of oral semaglutide in early Alzheimer’s disease.”

Alzheimer’s is a notoriously difficult therapy area, with a number of drug developers and researchers trying and ultimately failing to bring new therapies through the clinic.

One of the most promising potential treatments of late to come through the development pipeline for Alzheimer’s is Biogen’s aducanumab, which is currently under review with the US Food and Drug Administration (FDA).

However, even this treatment has been plagued by controversy, and it is not clear whether or not it will be able to score regulatory approval on the strength of the available data.

Article by
Lucy Parsons

17th December 2020

From: Research

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