TORONTO, Canada I July 27, 2016 I vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, today announced that Phase 2b data with azeliragon in early stage Alzheimer’s disease were reviewed in an oral presentation at the 2016 Alzheimer’s Association International Conference (AAIC). Data presented show that azeliragon 5mg/day was effective in delaying the time to cognitive deterioration when compared to placebo in patients with mild Alzheimer’s disease.
“Azeliragon is the only treatment in advanced development that works by inhibiting RAGE, which is believed to promote Aβ accumulation, tau hyperphosphorylation and chronic inflammation, the leading pathologies in Alzheimer’s disease,” commented Larry Altstiel, M.D., Ph.D., Chief Medical Officer of vTv Therapeutics. “These highly promising data from our Phase 2b study provide further confidence in azeliragon as a disease-modifying therapy, and support the design of our ongoing pivotal Phase 3 STEADFAST trial in mild Alzheimer’s disease.”
Results of Responder Analysis
A responder analysis was investigated in the mild disease population (MMSE 21-26) from an 18-month, placebo controlled Phase 2b trial in mild-to-moderate Alzheimer’s disease.
The analysis was performed using a cut-point of a 7-point increase in ADAS-Cog11 score (an accepted measure of meaningful change in degree of dementia, Vellas et al. 2007) to measure disease progression. For the 7-point cut-point measure, subjects with mild Alzheimer’s disease taking 5 mg/day azeliragon had a significant reduction in time-to-progression, with a hazard ratio of 0.5 (log-rank p=0.02) compared with placebo.
As previously reported, subjects with mild-to-moderate Alzheimer’s disease in the trial treated with 5mg/day of azeliragon had a mean decreased decline in ADAS-Cog11 at 18 months compared to placebo (ADAS-Cog11: 3.1, p=0.008). Patients in the study with mild disease had an even larger benefit in decreasing deterioration in both cognitive outcomes (ADAS-Cog11: 4.0, p=0.018) and functional measures (CDR-sb: 1.0, p= 0.01).
A copy of the presentation will be made available in the News & Events section of the Company’s website.
About Azeliragon
Azeliragon is a novel orally administered small molecule antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) being evaluated in a pivotal Phase 3 study (STEADFAST). Activation of RAGE is believed to contribute to Alzheimer’s disease by promoting an influx of amyloid beta into the brain, increasing hyperphosphorylation of tau, and promoting vascular amyloid deposition and inflammation. By inhibiting RAGE, azelerigon may reduce amyloid beta accumulation, tau hyperphosphorylation and chronic inflammation, three of the principal causes of neuronal damage in Alzheimer’s disease.
About the STEADFAST Trial
The Phase 3 STEADFAST trial is a randomized, double-blind, placebo-controlled study evaluating whether azeliragon can effectively slow the cognitive and functional decline of patients with mild Alzheimer’s disease (AD). The Company anticipates enrolling 800 patients in the United States and Canada who will receive 18 months of treatment, and expects to report topline data for Part A of the study in late 2017/early 2018. The STEADFAST trial is being conducted under a Special Protocol Assessment (SPA) and the azeliragon development program has been granted Fast Track Designation from the FDA.
About vTv Therapeutics
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.
SOURCE: vTv Therapeutics
