Another Alzheimer’s antibody drug fails large trials

Another Alzheimer’s drug bites the dust. Today, Eli Lilly and Company, based in Indianapolis, Indiana, announced that the biologic drug solanezumab did not meet its pre-specified endpoints to slow cognitive and functional decline in patients with Alzheimer’s disease who participated in two phase III clinical trials. However, a secondary analysis found some hints that the drug slowed cognitive decline in patients with milder forms of the neurodegenerative condition.

Bapineuzumab, a similar drug being developed by Johnson & Johnson, based in New Brunswick, New Jersey, and Pfizer, based in Groton, Connecticut, also failed two large-scale trials recently, and the companies announced plans to halt development (see ‘Alzheimer’s setback‘).

Both drugs are antibodies that target the amyloid-β peptide, which is thought to have a key role in Alzheimer’s disease. Researchers hope that the antibodies can  prevent the formation of the toxic clumps, or plaques, of amyloid-β, that may underlie neurodegeneration. Solanezumab is the first drug targeting amyloid-β to slow cognitive decline in a large trial, said Eric Siemers, medical director of Lilly’s Alzheimer’s team, during a press conference.

The Lilly-sponsored trials, which were double-blinded and placebo-controlled, enrolled 2,050 patients with mild to moderate forms of Alzheimer’s disease and lasted 18 months.

John Lechleiter, Lilly’s chairman, president and chief executive, said in a press release that he was encouraged by signs of efficacy slowing cognitive decline. “We intend to discuss these data with regulatory authorities to gain their insights on potential next steps.” However, another analysis of trial patients with mild Alzheimer’s disease did not find an effect on cognitive decline that reached statistical significance.

Lilly recently opened a new UK lab that will focus on neuroscience research and drugs (see ‘Eli freshens focus on neuroscience research‘). The company also owns the rights to a test for amyloid plaques that recently won approval by the US Food and Drug Administration (see ‘Alzheimer’s diagnostic probe approved‘). Many scientists believe that early detection of Alzheimer’s disease will be important to designing clinical trials and treating the disease.

Leave a Reply

Your email address will not be published. Required fields are marked *