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Alzheimer’s Debate Does not Seem Positive

For AC Immune CEO Andrea Pfeifer, Ph.D., it’s all about biomarkers. The modest Roche-partnered business is capitalising on the tremendous moment underway in research for the neurodegenerative disease after establishing for the first time the promise of an anti-tau therapy in Alzheimer’s disease earlier this year. That moment, of course, began with Biogen’s Aduhelm’s approval under the fast pathway in June, based on biomarker data rather than efficacy.

The FDA’s action paved the way for new regulatory pathways for Alzheimer’s medicines, which have long struggled to gain traction in clinical trials despite the support of some of the world’s biggest pharmaceutical companies. Pfeifer, though, does not disregard the task ahead. She understands that in order to show clinical benefit, her company, like many others developing Alzheimer’s treatments, must back up biomarker research with clinical development.

However, she believes that if the FDA had not made its decision, Alzheimer’s drug development would have continued apace without a spark to keep it going. With the biomarker notion in mind, Pfeifer feels the field needs to generate new and better endpoints for clinical trials in disease. She believes that today’s studies aren’t sensitive or objective enough to detect a treatment’s benefit.

In August, AC Immune and Roche’s Genentech business announced that semorinemab, a monoclonal antibody, had shown the first clinical evidence of a tau-targeting therapy in a phase 2 trial. Semorinemab achieved one of the co-primary goals of reducing cognitive decline, but failed to achieve the second co-primary target of lowering the pace of functional decline. All of the study’s secondary measures were negative. Nonetheless, in the case of Alzheimer’s disease, a small amount of information goes a long way. According to Pfeifer, the partners are now considering an open-label extension of the experiment to learn more about the secondary endpoints.

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