Eli Lilly’s solanezumab sees dose increases in A4, DIAN Alzheimer’s disease studies; A4 study duration extended by 1.5 years – sources
Eli Lilly (NYSE:LLY) has increased the doses of solanezumab in both the A4 and DIAN studies of Alzheimer’s disease (AD), according to two sources familiar with the studies. The A4 study duration has also been extended by one and a half years, they added.
The sources did not comment on the new dose being used in the A4 study. The doses on both ClinicalTrials.gov pages are still listed as 400mg and have not been updated since the alleged protocol amendments.
The Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) and Dominantly Inherited Alzheimer's Disease (DIAN) studies are solanezumab’s final attempt at demonstrating efficacy, noted the first source. Should both studies fail, that will likely be the treatment death knell, he added. In November 2016, the company announced that the Phase III pivotal EXPEDITION-3 trial (NCT01900665) of solanezumab in mild AD patients did not meet the primary endpoint of Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14).
Analysts have also noted that the A4 study is likely the final chance for solanezumab to see usage as a preventative AD agent. While initial sales forecasts were USD 2bn by 2026, analysts have not provided updated sales figures since the close of the EXPEDITION-3 trial, noting difficulty in assessing sales potential due to the cost/complexity of PET-scanning asymptomatic patients.