![]() ![]() Like Aduhelm, it is a monoclonal antibody targeting amyloid-beta plaque build-up.ĭonanemab has a PDUFA date scheduled for January 2023 and will likely face questions over its patient benefit. Looking ahead, multiple upcoming regulatory decisions for amyloid-targeting treatments could set the stage for the future of AD research. Industry sponsors 87% of AD studies targeting amyloid directly, compared to 63% of overall AD trials. It would likely take a clear-cut trial success in an AD target outside of the amyloid hypothesis to move the field away, he adds.Ĭurrently, the pharma industry sponsors most ongoing Phase I–III trials in AD, and that percentage is even higher among the trials targeting amyloid directly. The field will likely pursue trials using this theory for another 10–20 years given the significant current investment, he explains. The alpha-adrenergic receptor is a precursor to amyloid.ĭespite the controversies, Perry does not expect the AD field to move away from the amyloid theory anytime soon. ![]() AchE induces build-up of amyloid fibril, the main component of amyloid-beta plaque. Targets related to amyloid include the enzyme acetylcholinesterase (AchE) and the alpha-adrenergic receptor. Experts questioned whether marginal changes in the Phase II’s primary endpoint of Integrated Alzheimer’s Disease Rating Scale (iADRS) benefited patients Phase III assets targeting amyloid directly include Eli Lilly’s donanemab, a monoclonal antibody with concerns over its Phase II trial. ![]() GlobalData is the parent company of Clinical Trials Arena. For context, up to 16 assets have targets separate from the amyloid theory. Among ongoing Phase III trials with listed targets, 17 assets target amyloid directly and at least 16 candidates have amyloid-related targets. Most AD funding and research is heavily invested into the amyloid theory due to longstanding support from prominent experts, says Dr George Perry, Chair of Neurobiology at University of Texas at San Antonio.Īccording to GlobalData’s Clinical Trials Database, amyloid and amyloid-related targets are among the most common approaches in ongoing AD clinical trials. ![]()
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