Eli Lilly and Company (Lilly) said that its anti-amyloid monoclonal antibody solanezumab failed to meet the primary endpoint in the phase 2/3 Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study.
Based on the result of the primary endpoint, Lilly has dropped its plan to pursue regulatory submission for solanezumab in people having dominantly inherited Alzheimer’s disease (DIAD) or autosomal dominant Alzheimer’s disease.
According to Lilly, the DIAN-multivariate cognitive endpoint (DIAN-MCE) includes the Wechsler Memory Scale-Revised Logical Memory Delayed Recall, Wechsler Adult Intelligence Scale-Revised Digit Symbol Substitution Test, Cogstate International Shopping List Test, and the Mini Mental State Examination.
The analysis of the primary endpoint in the phase 2/3 placebo-controlled study was carried out by the Washington University School of Medicine. Further analysis of secondary endpoints and biomarkers of the trial are being carried out by Lilly and Washington University.
The goal of the DIAN-TU Study was to evaluate potential disease-modifying therapies in people who are at risk for or with DIAD. The trial began in 2010 as a two-year biomarker target engagement study, and eventually advanced into a phase 2/3 registration study having a primary cognitive outcome measure and a minimum of four years of treatment.
The primary efficacy analysis of the DIAN-TU Study included 50 solanezumab and 40 participants, who were subjected to placebo. Lilly said that 36 solanezumab particioants completed the minimum four-year treatment period compared to 32 placebo participants.
The company also said that the result of the DIAN-TU Study does not affect the solanezumab Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study, which is in progress. The A4 Study is a clinical trial that has been evaluating the anti-amyloid monoclonal antibody in older people who have evidence of amyloid in their brains, but do not display symptoms of memory impairment.
Lilly chief scientific officer and Lilly Research Labs president Daniel Skovronsky said: “We are grateful to the courageous participants, their families, and clinical investigators for their dedication to the study. We look forward to the opportunity to analyze 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.”