Data from Pharmawand - Curated by EPG Health - Date added 11 February 2020
Eli Lilly and Company announced that the analysis performed by Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that solanezumab did not meet the primary endpoint. Additional analyses of secondary endpoints and biomarkers are ongoing by Washington University and Lilly. Results will be presented at the Advances in Alzheimer's and Parkinson's Therapies (AAT-AD/PD™) Focus Meeting in April of 2020.
At this time, Lilly does not plan to pursue a submission for solanezumab in people with dominantly inherited Alzheimer's disease (DIAD), also known as autosomal dominant Alzheimer's disease, based on the result of the primary endpoint. This outcome does not impact the ongoing solanezumab Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) Study.
The DIAN-TU platform trial is a Phase II/III randomized, double-blind, placebo-controlled study. The goal is to test potential disease-modifying therapies in individuals at risk for or with dominantly inherited Alzheimer's disease, which is caused by rare gene mutations. It began as a two-year biomarker target engagement study and evolved into a Phase II/III registration study with a primary cognitive outcome measure and a minimum of four years of treatment.The primary efficacy analysis included 50 solanezumab and 40 placebo participants. The minimum four-year treatment period was completed by 36 solanezumab and 32 placebo participants. The initial study dose was 400mg every four weeks. A late amendment to the study increased the dose resulting in approximately 25 percent of the total doses being administered at the 1600mg level.
The DIAN-TU Study, which was established in 2010 and funded by Lilly, Roche and Genentech, National Institutes of Health, and other donors, is the first disease prevention trial to test investigational Alzheimer's disease compounds with different mechanisms of action from two pharmaceutical companies. The collaboration between Lilly, Washington University, Roche and Genentech combined research, resources, and expertise for a common goal of serving patients and their loved ones battling this devastating disease.