This is why we needed Biogen to be approved Example whyPMN needed Biogen to be approved and not as important that Biogen's AD treatment worked well.
With all the attention on aducanumab and donanemab these days (see previous stories in this series), lecanemab has been flying under the radar. Yet this often overlooked anti-amyloid antibody from Eisai/Biogen potently clears amyloid while producing less brain edema than its competitors. At the Clinical Trials on Alzheimer’s Disease conference, held in Boston and online November 9-12, Lars Lannfelt of Uppsala University, Sweden, made a case for lecanemab, aka BAN2401, being the strongest binder of aggregated Aβ among the current crop of anti-Aβ42 antibodies. Lannfelt led the BioArctic Neuroscience team that developed this antibody. Other talks at CTAD touted the consistency of lecanemab Phase 2 data, and added more evidence that it curbs tau pathology.
- Lecanemab binds protofibrils more tightly than fibrils, perhaps explaining lower ARIA rate.
- Use of plasma biomarkers brings down trial screening cost.
- Lecanemab has been selected for the first amyloid-tau concurrent therapy trial.
Lecanemab may soon become widely available; Eisai/Biogen have begun submitting data to the Food and Drug Administration to support its accelerated approval (Oct 2021 news). In the meantime, studies are ongoing, with this passive immunotherapy now in a trio of trials. CTAD speakers gave updates on screening improvements in the Phase 3 Clarity trial and the AHEAD 3-45 prevention study, which enrolls cognitively healthy people with amyloid plaques. Lecanemab has also been selected for the DIAN-TU Tau Next Generation trial, which enrolls people with an autosomal-dominant AD mutation. Tau NexGen will be the first trial to test combined amyloid and tau immunotherapies.
Randall Bateman of Washington University in St. Louis, who leads DIAN-TU, told Alzforum that combination therapy has long been the goal of the program. He believes the FDA’s approval of aducanumab opened the door for combination trials by creating demand for anti-amyloid agents. “The aducanumab approval changed the field’s perception of what is possible,” Bateman told Alzforum. “I think monotherapy trials’ days are numbered.”