ADDF: Anti-amyloids are a promising starting point

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The phase 3 trial results for lecanemab and gantenerumab presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference demonstrate why optimal treatment of Alzheimer’s will require drugs that do more than clear amyloid plaques, says the Alzheimer’s Drug Discovery Foundation (ADDF).

Based on study results presented this week at the CTAD event and published in The New England Journal of Medicine, amyloid-clearing drug lecanemab—poised for FDA approval early next year—will be a positive step in the treatment of Alzheimer’s, said the organization.

While lecanemab had an effect on slowing cognitive decline and removing amyloid plaques in the brain, gantenerumab had neither effect according to data reported by drugmaker, Roche.

“This is a historic CTAD conference, reflecting tremendous progress in Alzheimer’s research and drug development. We have seen a lot of encouraging news, including the lecanemab results and clinical trial data from other classes of drugs that demonstrate the diversity of the pipeline,” said Dr Howard Fillit, co-founder and chief science officer at the ADDF. “The mixed data shows that while anti-amyloids are a promising starting point, we will need a combination of drugs aimed at different targets informed by the biology of aging to effectively treat this disease.”

According to Dr Fillit, the results presented at the CTAD conference demonstrate the need to study and evaluate each drug on its own merits – especially with an additional anti-amyloid antibody from Eli Lilly, donanemab, expected to share data early next year – and the need to pursue every reasonable avenue to find treatments aimed at inflammation, vascular and metabolic dysfunction, genetic variations, and other underlying causes of Alzheimer’s disease.

Combination drug approach 

The ADDF has long held that a combination drug approach is needed, given that Alzheimer’s is a complex disease with multiple underlying causes tied to the biology of aging.

"Unique drug combinations matched to each patient’s underlying pathologies is the answer, and our best hope to give patients long-lasting relief from this insidious and progressive disease,” said Dr Fillit.

Robust pipeline

Today’s Alzheimer’s drug pipeline is more robust than ever, with 75% of drugs currently in clinical trials aimed at novel targets beyond amyloid and tau according to a recent report.

The rapidly advancing drug pipeline is matched by ongoing breakthroughs in accessible and affordable diagnostic tools that can tell which underlying causes are at play in each person’s Alzheimer’s, reported the group. Blood tests that can provide key information about amyloid and tau levels in the brain are now available commercially and other minimally invasive tests, including blood tests and eye scans, will soon be available. Researchers are also making advances in the use of digital tools, including wearable devices and at home digital tests, to provide earlier-than-ever diagnosis of Alzheimer’s, perhaps even before symptoms are evident, noted the ADDF.

The entire Alzheimer’s ecosystem has worked diligently to get us to this point,” said Dr Fillit. “It’s has taken decades of scientific study, learning from every success and setback, risk-taking investment by the ADDF and other venture philanthropies, and the scientific curiosity of researchers across the world to get us here. I can’t wait to see what’s next.”