Enrollment For Phase 3 Trial Evaluating Azeliragon in Treatment of Patients with Mild Alzheimer's Disease

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 has begun. 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.

STEADFAST is a randomized, double-blind, placebo-controlled Phase 3 study that is investigating the efficacy of Azeliragon as a potential disease modifying therapy for patients with mild Alzheimer's disease. The trial targets enrollment of 800 patients in the United States and Canada who will receive 18 months of treatment. The protocol is being conducted following agreement with FDA under the Special Protocol Assessment (SPA) process.

"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.

vTv is actively recruiting and enrolling new patients for the STEADFAST Study. Physicians and researchers looking for more information about the trial can visit www.livingsteadfast.com.