Eli Lilly has revealed that its Alzheimer’s drug solanezumab did not meet the primary endpoint in the DIAN-TU Phase II/III. The company says that additional analyses of secondary endpoints and biomarkers are still ongoing, and will be presented at the Advances in Alzheimer's and Parkinson's Therapies Focus Meeting in April of 2020.
Lilly says that it does not plan to pursue a submission for solanezumab in people with dominantly inherited Alzheimer's disease, based on the results, and also that the disappointing outcome does not impact its ongoing solanezumab Anti-Amyloid Treatment in Asymptomatic Alzheimer's Study.
The company is “grateful to the courageous participants, their families, and clinical investigators for their dedication to the study. We look forward to the opportunity to analyse the data so that we may continue to propel the science forward and bring hope to these patients," said Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Labs.
"Lilly is committed to finding treatments for patients and remains excited about the potential of our medicines under development in the area of Alzheimer's."
Earlier this month Roche also announced that its experimental drug, gantenerumab, did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease.
The pharma giant said that the treatment did not show a significant slowing of the rate of cognitive decline in people treated, and that it will conduct additional analyses to understand the totality of the gantenerumab data from the study.
Alzheimer's is a complex disease and one of the largest challenges facing healthcare today, with lots of failed treatments in past pipelines.
Last year, Biogen and Eisai also stopped two global Phase III trials of the Alzheimer's drug aducanumab, after interim analyses indicated that the agent was ineffective and would not meet the primary endpoint.
With few treatments available, and none that can tackle the course of the underlying disease, Alzheimer’s and other dementias are now the country’s leading cause of death.