Eli Lilly's solanezumab slowed cognitive decline by 34% in patients with mild forms of Alzheimer's disease, according to an independent analysis of pooled data from the EXPEDITION trials.
There are currently very few treatments for Alzheimer's disease on the market, and those that are focus on addressing the symptoms of the illness but not its actual cause.
Lilly's anti-beta-amyloid monoclonal antibody has been designed to bust the protein plaques thought to play a pivotal role in the development of the disease.
But there was disappointment earlier this year when, looking at data from the EXPEDITION trials individually, they failed to meet their cognitive and functional primary endpoints.
However, a secondary analysis of combined data in patients with mild AD showed that the drug slowed cognitive function by 34% compared to the control group. There was also a 17% reduction of functional decline, though this finding was not statistically significant compared with placebo, and its safety profile seems encouraging.
'Encouraging' data
"The data results from the solanezumab Phase III trials were encouraging to the Alzheimer's Disease Cooperative Study team," said Rachelle Doody, professor of neurology and the Effie Marie Cain Chair in Alzheimer's Disease Research at the Baylor College of Medicine.
"These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of AD therapies," she said. While the data are unlikely to be sufficient for a regulatory approval without additional trials, investors welcomed the news, pushing Lilly's stock to close up 5.2% on Monday.
Pfizer and Janssen also suffered a knock-back earlier this year its investigational Alzheimer’s drug bapineuzumab was proved to be no better than placebo in a Phase III study. But both firms were also given a reprieve in September when a new trial found it may benefit a sub-group of patients.
The potential blockbuster status of both drugs have taken a hit, however, and future regulatory filings will most likely be based on smaller populations than originally hoped for by the firms.
