If this story sounds familiar, that’s because it is. vTv revealed in April that azeliragon had flubbed an identical phase 3 study, but essentially said: hold on, let’s not pronounce death until we’ve evaluated data from both studies.
Specifically, azeliragon failed in Parts A and B to beat placebo in improving patients’ Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) scores after 12 months of treatment.
Despite the double flop, vTv is staying optimistic. It’s following up with “expedited discussions” with the FDA to “propose a pathway for future clinical development” that could support an approval for the candidate.
Its ray of hope is a correlation between lower maximal plasma concentrations of azeliragon and improvements in efficacy.
“We are eager to obtain early feedback from the FDA based on the results we have achieved and the data that we have observed associating lower plasma levels of the drug and improved efficacy,” said vTv CEO Steve Holcombe in a statement. “As a result, we believe that azeliragon has the potential to address the pressing unmet need in Alzheimer’s disease.”
It has been a long, hard road for azeliragon. Before vTv picked it up, it had already failed several midstage trials as a solo therapy, but showed promise when given in combination with Aricept, a dementia drug developed by Pfizer and Eisai. So much promise that vTv got off a $117 million IPO built around the Pfizer castoff.
Jun 13, 2018