On 8 March, the pharmaceutical company Eli Lilly provided an update on its A4 Study of solanezumab for preclinical Alzheimer's disease (AD). Launched in 2013, the A4 study was a double-blind and placebo-controlled Phase III study testing the anti-amyloid drug, solanezumab, in cognitively normal older people (65-85 years old) who had brain PET scans showing evidence of amyloid build-up. The study included more than 1.100 participants who were randomised to receive either solanezumab or placebo and then were treated for approximately 4.5 years. The company reported that the trial failed to meet its primary goal of slowing cognitive decline. Secondary clinical outcome results were consistent with the primary outcome, numerically favouring placebo compared with solanezumab. Solanezumab targets soluble amyloid beta and treatment did not clear plaque or halt accumulation of amyloid in the brain. Safety results in the A4 Study were consistent with the safety profile observed in previous solanezumab Phase III studies.
Amyloid-Related Imaging Abnormalities with edema/effusion (ARIA-E) were uncommon and similar between treatment and placebo groups. The A4 Study concluded the clinical development of solanezumab. Raw data and analyses will be made widely available to researchers through the public-private partnership with the NIH-funded Alzheimer's Clinical Trial Consortium. Study results will be shared later in the year at scientific conferences. Lilly remains committed to fighting AD with its two late-stage Phase III clinicals trials of donanemab and remternetug and expects to announce results of donanemab in the second quarter of this year https://investor.lilly.com/news-releases/news-release-details/lilly-provides-update-a4-study-solanezumab-preclinical