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High hopes of a long-term treatment for Alzheimer’s Disease (AD) have been dealt another blow, due to the failure of a drug to slow the progression of the condition during global clinical trials.
The Swiss pharmaceutical firm Roche said its drug, gantenerumab, showed no clear benefit in twin trials which explored its impact on memory, problem solving and other cognitive skills in people with early stage Alzheimer’s.
“This news is very disappointing to deliver,”
said Levi Garraway, Roche’s chief medical officer.
Although gantenerumab was well tolerated, including during subcutaneous administration, it did not achieve the primary objective of slowing clinical decline.
This new treatment is so important because it is a type of drug called an anti-amyloid. A treatment that works directly on what may cause the disease, instead of just the symptoms.
People with Alzheimer’s disease have too much of a protein called beta-amyloid in their brains. These proteins clump together to form plaques. They build up between nerve cells in your brain called neurons and keep them from communicating with each other. That contributes to memory and thinking problems. So anti-amyloids target these protein fragments that build up and form plaques.
The Alzheimer’s Association said in a statement that “the trials further illustrate the relationship between beta-amyloid removal and reduced clinical decline. Each treatment is being tested differently and may act differently on the protein that is one of the hallmarks of Alzheimer’s. Research on its effectiveness and safety must continue. It is important to evaluate each new treatment independently” the organization said.
Twin Studies
The approval process for a new drug involves a number of studies and trials. The Phase 3 twin studies for gantenerumab evaluated the safety and efficacy of gantenerumab compared with placebo over 27 months in 1,965 adults from 30 countries. All had mild cognitive impairment due to AD and mild AD dementia.
Active treatment resulted in a relative reduction in clinical decline compared with placebo. However, none of the results were statistically significant, the manufacturer reported. He noted that the decrease in beta-amyloid level was less than expected with gantenerumab.
The company plans to present the main data from the trials in a presentation scheduled for Nov. 30 during the upcoming Alzheimer’s Disease Clinical Trials Conference.
“We know that current anti-amyloid approaches are not a cure, nor will they stop the disease by themselves, but they are the first wave of effective treatments for Alzheimer’s, with more to come,”
the Alzheimer’s Association said.
In a separate statement, the Alzheimer’s Drug Discovery Foundation (ADDF) said it remains “incredibly enthusiastic” about the current state of AD drug development despite the negative results for gantenerumab.
“While this is disheartening news for the many patients and families living with Alzheimer’s, anti-amyloid therapies are just the beginning of new therapies for Alzheimer’s patients,”
said Howard Fillit, MD, co-founder and scientific director of ADDF. the statement
“If you’ve seen an anti-amyloid therapy, then you’ve seen an anti-amyloid therapy,” Fillit said.
In reality, Fillit continues, treating AD will require a multi-drug approach. The AD drug pipeline is advancing a number of promising drugs that work against the many underlying causes of AD, which will enable combination therapies and a personalized medicine approach.
“Successes and disappointments are an expected part of the scientific process, but we are unmistakably in a modern era of Alzheimer’s research, on the cusp of a new generation of therapies that will take a more holistic approach to treating the disease by targeting -se to all its effects. underlying causes,”
Fillit said.
The trial failure is not the end of the World. Scientists know they are on the right track as in September a US-Japanese collaboration between Biogen and Eisai reported that a similar drug, lecanemab, slowed cognitive decline in patients. The first proven to do so.
“Years of relentless work by Alzheimer’s researchers have built the foundation for conducting more rigorous trials, allowing us to measure the effectiveness of new drugs more efficiently,” he added.
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