New Potential Alzheimer’s Treatment Entering Phase 3 Program

New Potential Alzheimer’s Treatment Entering Phase 3 Program

It seems almost impossible to accept that Alzheimer’s Disease and related memory loss and impairment from dementia have commanded countless billions of dollars of drug research without a single approved drug on the market anywhere yet. That is exactly where this tragedy stands heading into 2021. With more than 5 million Americans alone suffering from Alzheimer’s today, and with that number expected to rise to nearly 14 million by 2050, the entire world is eagerly awaiting a treatment that can receive drug approval of some sort.

Denmark’s Novo Nordisk has made the decision to enter a Phase 3 development with 14 mg oral semaglutide as a candidate to treat Alzheimer’s disease. The oral formulation will be taken once-daily and is a long-acting GLP-1 analogue semaglutide.

This is far from an FDA or EMA approval by any means, and it follows a recent disappointing FDA panel recommendation that was not in favor of Biogen. And more recently, a company called vTv Therapeutics Inc. announced that its Phase 2 study of azeliragon failed to meet its primary objective in people with mild Alzheimer’s disease and type 2 diabetes. And even if Novo Nordisk’s candidate shows promise, it could be years before real help is on the way.

Novo Nordisk’s decision to move into a Phase 3 development of 14 mg oral semaglutide follows and evaluation of GLP-1 data from preclinical models. The company also cited real-world evidence studies, as well as post-hoc analysis of data from large cardiovascular outcomes trials and discussions with regulatory authorities.

As for the good news about the oral semaglutide being studied against Alzheimer’s, the drug is approved as an adjunct to diet and exercise to help glycemic control in adults with type 2 diabetes in the U.S., the European Union and in Japan. Novo Nordisk noted that approval of Rybelsus was based on the results from 10 different clinical trials made up of more than 9,500 adults who have type 2 diabetes.

Additional good news was seen in the safety profile of oral semaglutide. The most common adverse events were shown to be mild to moderate nausea, and that was shown to have diminished over time.

The pivotal phase 3a program for Alzheimer’s is expected to start during the first half of 2021 and is expected to evaluate approximately 3,700 people with early Alzheimer’s disease. The efficacy and safety of the once-daily oral semaglutide will be compared to placebo, and the company had noted that the main treatment period in the trials is expected to be around two years.

The “real-world evidence” cited came from two Danish national registries, the U.S. Truven claims database and the U.S. FDA FAERS database — both of which are said to support a potential association between lower risk of dementia following treatment with GLP-1.

A post-hoc analysis of data from three large cardiovascular outcomes trials conducted by Novo Nordisk included 15,820 patients with type 2 diabetes with median follow-up of 3.6 years. The company noted that a total number of 47 people were identified with development of dementia, and 32 were on placebo and 15 on GLP-1. That created a statistically significantly rate of reduced dementia development by 53% in favor of GLP-1.

It is unknown exactly how much money has been poured into R&D programs to investigate and target Alzheimer’s disease. Many U.S. and international companies have even outright given up trying to defeat Alzheimer’s despite any drug approval likely landing instant blockbuster drug status with sales of more than $1 billion. There is still not even a universal agreement over the exact causes, nor over which proteins, plaques and other targets should be focused on.

It is estimated that approximately 70 million to 100 million people have early Alzheimer’s disease where they have mild cognitive impairment and/or mild dementia stages. The Alzheimer’s Association covers the statistics and other data in much more detail.

About The Author

Kendra Evans

Kendra Evans founded Inflammation Guide in April 2020. Our goal is keeping our readers informed to help them live an empowered and full life while they manage inflammation. Inflammation Guide provides a central location for breaking news and updates on prescriptions, treatments, supplements and alternative wellness solutions to give options to people living with at least one inflammatory condition.

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