vTv Therapeutics (NASDAQ:VTVT) initiated a Phase 2 trial of azeliragon in patients with Alzheimer’s disease (AD) and Type 2 diabetes (T2D).
Azeliragon is a small-molecule antagonist of the receptor for advanced glycation end products, which is believed to play a role in inflammatory diseases.
The trial will enroll some 100 patients who will be randomized to receive either 5 mg of azeliragon per day, or placebo. The primary endpoint is the change in cognition and function, and HbA1c, from baseline, at six months.
Thereafter, vTv plans to conduct a Phase 3 trial under the same protocol, enrolling some 200 patients for an 18-month treatment period.
“With positive results from this study, we would be able to move quickly into a pivotal Phase 3 trial in our pursuit of a treatment to help the millions of people suffering from mild AD and T2D, two devastating diseases,” Steve Holcombe, vTv’s president and CEO, said in a statement.
vTv expects to report topline Phase 2 results by the end of 2020.
