ProMIS Neurosciences has become the latest biotech to throw its hat in the ring of anti-amyloid antibodies targeting Alzheimer’s disease.
The Canadian pharma company will initiate a Phase Ia trial testing its monoclonal antibody PMN310 in healthy adults after gaining regulatory clearance with the US Food and Drug Administration (FDA). In later stages, ProMIS intends to test the drug in patients with Alzheimer’s disease.
ProMIS’s antibody follows a long line of anti-amyloid antibodies in the Alzheimer’s drug development space. PMN310 specifically targets toxic oligomers of amyloid-beta, which are thought to be a key driver of Alzheimer’s disease.
According to the long-held amyloid theory, stopping the accumulation of amyloid-beta plaque in the brain could slow Alzheimer’s progression. Amyloid plaque inhibition is the most common target in Alzheimer’s disease drug development, though some experts argue there could be better target pathways, according to GlobalData.
Anti-amyloid antibodies in Alzheimer’s disease
So far, two anti-amyloid antibodies have earned FDA accelerated approvals: Biogen’s Aduhelm (aducanumab) and Biogen’s and Eisai’s Leqembi (lecanemab). While Leqembi could become the market-leading Alzheimer’s therapy, Aduhelm has failed to gain market traction due to a series of high-profile controversies.
Meanwhile, the Alzheimer’s pipeline is full of late-stage anti-amyloid antibodies looking to join Leqembi and Aduhelm as FDA-approved therapies. Notably, Eli Lilly’s antibody donanemab reported positive Phase III results on May 3, setting the stage for a potential approval.
Nevertheless, it has not been all roses for anti-amyloid therapies. Last November, Roche announced that its antibody gantenerumab missed the primary endpoint in two Phase III trials. Some experts have also questioned whether amyloid is the optimal target in Alzheimer’s, arguing that the efficacy of anti-amyloid drugs has fallen short of stopping or reversing disease progression.
