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vTv Therapeutics begins Phase III trial of azeliragon to treat mild Alzheimer’s disease

US-based biopharmaceutical firm vTv Therapeutics has enrolled the first patient in its Phase III placebo controlled trial (Steadfast) of azeliragon, an oral antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) to treat mild Alzheimer's disease (AD).

The initiation of this Phase III trial follows a Phase II trial, which showed positive results in slowing cognitive decline with 5mg/day of azeliragon in patients with mild to moderate AD.

vTv president and CEO Steve Holcombe said: "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 III trial.

"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 trial is designed to evaluate the efficacy of azeliragon compared with placebo in the treatment of patients with mild AD already receiving cholinesterase inhibitors and/or memantine.

The company is currently enrolling new patients for the randomized, double-blind, placebo-controlled Phase III Steadfast trial.

Around 800 patients in the US and Canada will be enrolled in the trial and they will be given 18 months of treatment.

Azeliragon was developed using the company’s proprietary drug discovery platform TTP Translational Technology.