As World Alzheimer’s Day approaches (21 September) with the aim of raising global awareness and understanding of the issues faced by people affected by dementia it’s timely to reflect that no new drug for Alzheimer’s disease (AD) has been approved in the past 16 years, despite more than 400 clinical trials and billions of dollars being spent in an attempt to tackle the disease and address unmet needs, says GlobalData a leading data and analytics company.
According to GlobalData’s latest report, ‘Alzheimer’s Disease: Competitive Landscape to 2026’, the pipeline has been characterized by big failures, as AD drug development is considered to have one of the highest failure rates of all indications. The AD pipeline features 657 drugs across all stages of development, and out of these, only 3.2% of drugs are in late-stage development; which is dominated by small molecules and monoclonal antibodies. The report reveals that amyloid precursor protein (Aβ peptide and protein) and microtubule associated protein tau (MAPT) are the major targets being pursued by companies developing drugs against AD.
Alessio Brunello, Pharma Analyst at GlobalData, commented, ‘‘The need for new disease modifying drugs (DMDs) is urgent as the current competitive landscape in AD offers medications that are aimed at treating only the symptoms of the disease. A few key drugmakers have already stopped their research into AD, and given the significant amount of R&D failures, pharma companies may be disincentivized from producing new drugs.
“The amyloid hypothesis has been the central theory for the pathogenesis of AD, but all Aβ-targeting drugs treating AD have ended in failure. In fact, recent studies indicated that one of the main factors concerning the development and progression of the disease could be tau and not beta amyloid. We may, in the future, see tailored therapies to include potentially both an anti-amyloid and an anti-tau approach being administered concurrently.”
Currently, treatments for AD consist only of symptomatic treatments, of which there are only five approved medications: three cholinesterase inhibitors (ChEIs) (donepezil, rivastigmine, and galantamine), one N-methyl-D-aspartate receptor (NMDA-R) antagonist (memantine), and one combination therapy (memantine/donepezil). These leave a lot to be desired in terms of efficacy, routes of administration, and dosing frequencies.
The potential launch of promising monoclonal antibodies from Biogen (aducanumab) and Roche (gantenerumab and crenezumab) will boost the size of the Alzheimer’s market given their potential to halt or prevent disease progression. Most of the tau-targeting approaches that are currently in clinical trials are immunotherapies such as Axon neuroscience’s AADvac-1 and Eli Lilly’s LY3303560. Tau is more likely to be a better target than Aβ as the clinical stages of cognitive decline much better correlate with the number, density and distribution of tangles than does the Aβ burden.
Brunello concludes, ‘‘Monoclonal antibodies have shown more promise than anything in the pipeline and in the next 10 years, we’re going to have a good idea whether amyloid is really a meaningful player or not. The industry shifted a little to anti-tau therapies, showing that tau treatments represent a new direction with a possible combination approach if trials will provide positive results. In the absence of any proven disease-modifying therapy, if and when one will reach the market, the rewards in terms of profits for the developer would be huge.”
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