HIGH POINT, NORTH CAROLINA – September 7, 2016 – vTv Therapeutics Inc. (NASDAQ:VTVT) today announced the completion of enrollment for Part A of 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 follows a Phase 2b trial that demonstrated positive results in slowing cognitive decline with 5 mg/day of azeliragon in patients with mild to moderate Alzheimer’s disease.
“With completion of enrollment of patients in Part A of our Phase 3 trial, we are excited to reach another 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,” 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 targets a receptor that we believe is involved in multiple pathologic processes leading to the development and progression of Alzheimer’s disease.”
The Phase 2b results of 5mg per day of azeliragon over a period of 18 months showed statistically significant benefit in mild-to-moderate Alzheimer’s patients (+3.1 points on ADAS-Cog11 standard measure of cognition) and greater benefit in mild patients (+4.0 points on ADAS-Cog11), with improvements on secondary endpoints including a statistically significant reduction in psychiatric adverse events.
vTv is continuing to recruit and enroll new patients for Part B of the STEADFAST Study. Physicians and researchers looking for more information about the trial can visit www.livingsteadfast.com or call 336-841-0300 ext 120.
About the STEADFAST Study
STEADFAST is a randomized, double-blind, placebo-controlled Phase 3 trial 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 (400 for each Part A and B) in the United States and Canada who will receive 18 months of treatment. Enrollment of Part B will be expanded to include study sites in the United Kingdom, Australia, New Zealand and South Africa. Subjects completing the STEADFAST trial may be eligible to enroll in a 24-month open-label extension trial. STEADFAST is being conducted following agreement with FDA under the Special Protocol Assessment (SPA) process with fast track status. Data from Part A of the trial is expected to read out in early 2018 with Part B in late 2018.
vTv discovered and developed azeliragon using its proprietary drug discovery platform TTP Translational Technology®. A broad range of human pathologic and experimental biologic investigation suggests that RAGE activation contributes to the pathogenesis of Alzheimer’s disease. Sustained Amyloid-β interactions with RAGE at the blood-brain barrier (BBB) and in neuronal and microglial cells, play potentially major roles in amyloid plaque formation, neuroinflammation and chronic neural dysfunction – all hallmarks of Alzheimer’s disease. Azeliragon, also known as TTP488, is a novel orally active small-molecule antagonist of RAGE.
About vTv Therapeutics Inc.
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and type 2 diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness. Last month, vTv announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator (GKA) under development for the treatment of Type 2 diabetes.
The Company’s drug candidates were discovered with its high-throughput drug discovery platform, TTP Translational Technology®, which translates the functional modulation of human proteins into safe and effective medicines. For further company information, visit www.vtvtherapeutics.com.