Eli Lilly’s Alzheimer’s drug fails in phase 3 trial

The trial demonstrated that patients treated with solanezumab did not experience a statistically significant slowing in cognitive decline compared to patients treated with placebo.

The company said it will not go ahead with regulatory submissions for solanezumab to treat of mild dementia due to AD.

The phase 3 Expedition3 trial, which enrolled over 2,100 patients, includes an 18-month placebo-controlled period followed by an open label extension.

Eli Lilly completed enrollment in 2015 and the last patient visit for the placebo-controlled period took place last month.

It is the first phase 3 trial to assess only people with mild dementia due to AD.

Lilly chairman, president and CEO John Lechleiter said: “The results of the solanezumab Expedition3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer's disease.

"We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets."

Solanezumab is being studied as a potential therapy for people with mild cognitive impairment due to AD (Expedition -PRO), preclinical AD (anti-amyloid treatment in asymptomatic Alzheimer's), and dominantly inherited AD.

Dementia due to AD is the most common form of dementia, accounting for 60% to 80% of dementia cases.

It is estimated that there are about 47 million people living with dementia globally. The number of people affected by dementia is projected to increase to nearly 75 million in 2030 and 131 million in 2050.

Image: Eli Lilly and Company's global headquarters, in Indianapolis, Indiana, United States. Photo: courtesy of Guanaco152003.