Eli Lilly has reported top-line data from the Phase II/III DIAN-TU clinical trial of solanezumab in patients with autosomal dominant Alzheimer’s disease/dominantly inherited Alzheimer’s disease (DIAD) caused by rare gene mutations.
Data showed that the primary goal of the trial was not met. DIAN-TU is a randomised, double-blind, placebo-controlled study assessing solanezumab, which is an anti-amyloid monoclonal antibody.
The primary endpoint was the DIAN Multivariate Cognitive Endpoint (DIAN-MCE), which comprised four different cognitive performance tests.
The primary efficacy analysis involved 50 patients treated with solanezumab and 40 on placebo. Of these participants, 36 and 32 in solanezumab and placebo groups, respectively, completed the minimum four-year treatment period.
Lilly and Washington University School of Medicine are performing additional analyses of secondary endpoints and biomarkers.
Based on the primary endpoint data, Lilly will not submit a regulatory application for solanezumab in this indication. The company noted that these results will not impact the ongoing Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study of the drug.
Eli Lilly chief scientific officer Daniel Skovronsky said: “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.
“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.”
The DIAN-TU trial was funded by Lilly, Roche and Genentech, and National Institutes of Health, among others. The study also assessed Roche’s gantenerumab, which attaches to aggregated beta-amyloid and eliminates the plaques.
Data showed that gantenerumab did not lead to a significant deceleration of the cognitive decline rate and failed to meet the primary goal.