Anavex Life Sciences Corp (AVXL)

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Another competitor bites the dust.

Press Release: vTv Therapeutics Announces Topline Results from the First STEADFAST Phase 3 Study Evaluating Azeliragon in People with Mild Alzheimer's Disease
vTv Therapeutics Announces Topline Results from the First STEADFAST Phase 3 Study Evaluating Azeliragon in People with Mild Alzheimer's Disease

HIGH POINT, N.C.--(BUSINESS WIRE)--April 09, 2018--
vTv Therapeutics, Inc. (vTv) (Nasdaq:VTVT) today announced that results from Part A of the Company's Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer's disease did not meet either co-primary efficacy endpoint. Patients taking azeliragon compared with placebo did not improve in cognitive or functional outcomes as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).

The STEADFAST study is comprised of two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (Part A and Part B). The azeliragon treated group in Part A had a 4.4 point decline from baseline in ADAS-Cog and a 1.6 point decline from baseline in CDR-sb compared to a placebo decline of 3.3 and 1.6 respectively. These differences were not statistically significant. Azeliragon was generally well-tolerated with a 25% withdrawal rate over 18 months that was similar in both the placebo and treatment arms.

vTv Therapeutics is discontinuing current clinical studies involving azeliragon, including the open-label extension study and Part B of the STEADFAST study. Given the progress to date of STEADFAST Part B, the company expects that a substantial portion of the patients in Part B of STEADFAST will have completed 12 months of treatment under the study protocol. vTv Therapeutics will continue to thoroughly evaluate subset data from Part A and then the dataset from Part B over the coming weeks.

"We will continue to analyze the datasets and trends within subgroups from both Part A and Part B to determine if there are potential benefits or future uses and applications for azeliragon," said Steve Holcombe, chief executive officer, vTv Therapeutics. "On behalf of vTv Therapeutics, we'd like to extend our most sincere and heartfelt gratitude to study participants, their families, physicians and caregivers for their commitment to this important study."

About Azeliragon

vTv Therapeutics discovered and developed azeliragon using its proprietary drug discovery platform, TTP Translational Technology(R). A broad range of human pathologic and experimental biologic investigation suggests that RAGE activation may contribute to the pathogenesis of Alzheimer's disease. Azeliragon, also known as TTP488, is conceived as a novel orally active small-molecule antagonist of RAGE.