Elan's first-in-class Alzheimer's therapy enters Phase II testing

Elan has announced plans to start a Phase IIa study of AN-1792(AIP-001), an experimental immunotherapy for Alzheimer's disease developed in collaboration with American Home Products' subsidiary Wyeth-Ayerst, in the third quarter of this year. The drug, a synthetic version of beta amyloid peptide, is designed to stimulate an immune response against the amyloid plaques in the brain that are a hallmark of AD, in the hope that resolving these plaques may interfere with the progression of the disease.

Results from Phase I studies of the peptide in more than 100 patients with mild-to-moderate AD indicate that it is well-tolerated and that a portion of patients who received it developed a sufficient immunological response to warrant the initiation of additional studies, said Elan.

This clinical work is an extension of earlier animal studies which showed that the peptide stimulated an immune response which substantially inhibited the formation of plaques and slowed the disruption of neurons, as well as protecting against memory and learning deficits, in mouse models. However, because the peptide itself is related to the toxic fragment thought to cause neuronal degeneration, the Phase I studies have taken on added significance, and a positive result does much to enhance the prospects of this program.