|vTv Therapeutics Completes Enrollment of Part B of Pivotal Phase III STEADFAST Trial Evaluating Azeliragon for the Treatment of Patients with Mild Alzheimer’s Disease|
-- Azeliragon is the only RAGE receptor antagonist in clinical development for Alzheimer’s Disease --
“To date, vTv is the only company with a clinical stage RAGE program in
Alzheimer’s disease, and completion of enrollment in this trial marks a
significant milestone for the company and an important step forward for
the Alzheimer’s community,” said
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 difference in change from baseline between azeliragon and placebo 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.
STEADFAST, a randomized, double-blind, placebo-controlled Phase 3 trial,
is investigating the efficacy of azeliragon as a potential treatment to
slow the decline in cognition and functional activities for patients
with mild Alzheimer’s disease. The 18-month trial targeted enrollment of
800 patients (400 for each Part A and B). Part A enrolled patients in
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.
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.
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