The Impact Of Eli Lilly On A Therapy For Mild Alzheimer s...

SLINGSHOT CONTRIBUTOR: Phil Loria This week I will discuss recent developments with Eli Lilly (LLY) and BioDelivery Sciences (BDSI) that have caught the attention of many biotech investors. On Tuesday Lilly announced that they are changing the endpoints in their Phase III trial (EXPEDITION3) evaluating Solanezumab as a therapy for mild Alzheimer s dementia, prodromal Alzheimer s dementia, and preclinical Alzheimer s disease. Originally the trial had co-primary endpoints of cognition and function; it will now use cognition as the single primary endpoint with functional outcomes being used as key secondary endpoints. This is a surprising move because it goes against regulatory guidance and was done without approval from the FDA. The trial is well underway with final results expected to come in the fourth quarter. Amending primary endpoints this late in a program without advice from regulators is almost unheard of, and it certainly raises a lot of questions about the trial. Although there is no cure for Alzheimer s, there are several approved drugs that are used to help patients with cognition and function. In their last release from a pre-specified secondary analysis of the Phase III trials, the data suggested that (Solanezumab) had an effect that is consistent with slowing progression of disease by modifying the underlying disease progression. Alzheimer s therapies haverarely done well in trials, and any drug that can demonstrate a positive effect on cognition and