News & numbers
Alzheimer’s disease: What’s in the pipeline? There are currently 126 therapeutic agents being tested in 152 trials in the US
82.5%
Disease modifying treatments (DMTs):
or 104 of agents target the underlying biology of Alzheimer’s with the intent of disease modification
Phase 1
■ 24 agents in 24 trials ■ 10 of which are repurposed ■ 23 potential DMTs, one cognitive enhancing agent and none targeting behavioural symptoms
10.3% 7.1%
Phase 2
■ 74 agents in 87 trials ■ 30 of which are repurposed
■ 64 potential DMTs, six cognitive enhancing agents and four targeting behavioural symptoms
Cognitive enhancing agents:
or 13 of agents seek to enhance cognitive function in Alzheimer’s patients
Neuropsychiatric symptoms
or nine of agents are intended
to treat neuropsychiatric and behavioural symptoms
Phase 3
■ 28 agents in 48 trials ■ 10 repurposed agents ■ 17 DMTs, six cognitive enhancers and five targeting behavioural symptoms
■ Five of the DMTs target amyloid
The pharmaceutical market was shocked this year as the first drug to target amyloid plaques was given accelerated approval by the FDA on 7 June. The approval was granted on the condition that Biogen, maker of the drug aducanumab, which it branded as Aduhelm, runs a phase 4 trial to prove clinical benefit – the results of which could decide whether it stays on the market or not. While aducanumab has its critics, many believe its approval has given regulatory validation to the hypothesis that reducing clumps of peptide amyloid- in the brain is an effective way to treat the disease. An inescapable consequence of this is that the door is now open for the approval of other treatments with the same therapeutic target.
What treatments could be approved?
Despite the accelerated approval of aducanumab, not all amyloid-focused treatments are following suit and requesting the same pathway. But the fact that the three below have amyloid as their main target could make them worthy contenders to follow in aducanumab’s footsteps.
Gantenerumab
A monoclonal antibody from Roche aims to clear amyloid-β plaques, but the company has dismissed rumours that it will request early approval before it delivers results from four ongoing phase 3 trials.
Donanemab
A monoclonal antibody from Eli Lilly designed to clear amyloid-β plaques. Studies have shown the drug can reduce cognitive decline in the early stages of Alzheimer’s. It is currently seeking approval through the same pathway as aducanumab.
Lecanemab
A monoclonal antibody developed by Eisei and Biogen that targets pre-fibrillar intermediates in the process of peptide aggregation into amyloid plaques. The duo are seeking the same accelerated approval as aducanumab.
Source: Alzheimer’s association Clinical Trials Insight /
www.worldpharmaceuticals.net 9
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