vTv Therapeutics enrolls first patients in azeliragon Phase 3 trial for treatment of mild Alzheimer's disease

vTv Therapeutics LLC (vTv) today announced enrollment of the first patients into STEADFAST (Single Trial Evaluating Alzheimer's Disease Following Addition to Symptomatic Therapy), vTv's Phase 3 placebo controlled trial of azeliragon, an oral antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) for treatment of mild Alzheimer's disease. Phase 3 begins following a Phase 2 trial that demonstrated positive results in slowing cognitive decline with 5 mg/day of azeliragon in patients with mild to moderate Alzheimer's Disease.

"We are excited to reach this next significant milestone in the development of azeliragon as a potential therapy to slow the decline of cognition and function in patients with Alzheimer's disease by enrolling our first patients in our phase 3 trial," said Steve Holcombe, President and CEO of vTv. "There remains a critical need for the development of new treatments for this devastating disease. Azeliragon's novel mechanism allows for targeting a receptor we believe is involved in multiple pathologic processes leading to the development and progression of Alzheimer's disease."

The STEADFAST Study will investigate the efficacy of azeliragon compared with placebo in the treatment of patients with mild Alzheimer's disease already receiving cholinesterase inhibitors and/or memantine.