Investigational Alzheimer's Drug Fails in Clinical Trial

Eli Lilly will not continue development on solanezumab for patients with mild cognitive impairment from Alzheimer’s disease.

Eli Lilly and Company recently announced that their investigational drug solanezumab did not meet the primary endpoint of a phase 3 clinical trial.

Solanezumab is a monoclonal antibody under evaluation in patients with mild cognitive impairment from Alzheimer’s disease, preclinical Alzheimer’s disease, and dominantly inherited Alzheimer’s disease.

The EXPEDITION3 trial is a placebo-controlled clinical study that included more than 2100 patients with mild dementia resulting from Alzheimer’s disease. Investigators found that patients taking solanezumab did not demonstrate a slowing in cognitive decline compared with patients taking the placebo (p=0.95), according to a press release from Eli Lilly.

The researchers found that many of the secondary endpoints were met, but the findings were not clinically significant. There were no additional safety concerns outlined in this study.

Due to the negative findings, Eli Lilly will not be seeking regulatory approval of solanezumab for the treatment of mild dementia from Alzheimer’s disease, according to the press release.

“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,” said John C. Lechleiter, PhD, chairman, president and chief executive officer of Eli Lilly. “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer's pipeline assets.”

The company plans to work with the scientists conducting the open-label extensions for the EXPEDITION, EXPEDITION2, and EXPEDITION3 clinical trials to appropriately end them. Eli Lilly has not yet determined their next steps regarding the solanezumab development program.

"Lilly is grateful for the dedication of the patients, their families, and the clinical investigators who participated in this study," said Jan Lundberg, PhD, executive vice president of science and technology and president of Lilly Research Laboratories. "Lilly remains committed to Alzheimer's research as we have been for nearly 30 years, and our portfolio includes many other promising approaches."

Additional findings will be presented at the Clinical Trials on Alzheimer’s Disease meeting. Due to the discontinuation of solanezumab for this indication, the company will update its 2016 and 2017 financial guidance materials.

The same day they announced these findings, Eli Lilly also released a video dedicated to patients, caregivers, and physicians affected by Alzheimer’s disease. In the video, Dr Lechleiter discusses the history of Alzheimer’s disease in the home of Dr Alois Alzheimer, which Lilly has purchased.

The video outlines Lilly’s continuing commitment to patients with Alzheimer’s disease, and continuing their clinical research to create novel treatment options.

"Lilly has strong growth prospects without solanezumab," said David A. Ricks, Lilly's incoming chief executive officer and president of Lilly Bio-Medicines. "Driven by new product launches, we continue to expect to grow average annual revenue by at least 5 percent between 2015 and 2020. Over that time frame, we also expect to increase our margins and provide annual dividend increases to our shareholders."