Press Release

Presentation of Results for Subgroup of Patients with Mild Alzheimer’s Disease and Type 2 Diabetes in the STEADFAST Study

HIGH POINT, N.C.--(BUSINESS WIRE)--Mar. 28, 2019-- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered treatments for Alzheimer’s disease and diabetes, today announced that its Chief Scientific Officer, Carmen Valcarce, will be presenting at the 14^th International Conference on Alzheimer’s & Parkinson’s Diseases held in Lisbon, Portugal, March 26-31, 2019.

The presentation will describe the post-hoc analyses of MRI brain volume measures, brain FDG-PET measures of glucose uptake and plasma markers of inflammation in a subgroup of patients with type 2 diabetes, defined as having glycosylated hemoglobin (HbA1c) greater than 6.5%, and mild Alzheimer’s disease in the azeliragon Phase 3 study, STEADFAST.

The results support the hypothesis that treatment with azeliragon may improve cognition and/or preserve function in patients with type 2 diabetes and mild Alzheimer’s disease, showing favorable trends for less whole brain atrophy, less ventricular enlargement, and smaller decreases in glucose uptake in the azeliragon-treated subgroup compared to placebo. Additionally, the results from the inflammatory marker analyses revealed changes consistent with RAGE inhibition, possibly indicating functional pharmacologic activity of azeliragon in this subgroup of patients.

Details of the presentations are below:

Abstract Number: ADPD9-2202

Abstract Title: Inflammatory Biomarkers, Brain Volumetric MRI, FDG-PET Results in Patients with Type 2 Diabetes in Azeliragon Phase 3 Trial in Mild Alzheimer’s Disease

Saturday, March 30, PLENARY HALL - Auditorium I, 17:15-19:15
SYMPOSIUM 57: AD TREATMENT STRATEGIES

The data will be available on the Publications page of the Company website following the presentation.

About Azeliragon

Azeliragon, also known as TTP488, is an orally active small-molecule antagonist of RAGE. vTv Therapeutics 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 ligand interactions lead to sustained inflammatory states that play a role in chronic diseases such as diabetes, inflammation, and AD.

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, diabetes, and inflammatory disorders.

About STEADFAST

The STEADFAST study, two independent and identical randomized, double-blind, placebo-controlled Phase 3 trials (Part A and Part B), was designed to investigate the safety and efficacy of azeliragon as a potential treatment for patients with mild Alzheimer’s disease. The 18-month study targeted enrollment of 800 patients (400 in each trial). The first trial enrolled patients in the United States and Canada who had a clinical diagnosis of mild Alzheimer's disease and an MRI consistent with this diagnosis. Enrollment of the second trial also included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa. In April 2018, results were announced that the Part A Study failed to meet either co-primary endpoint and clinical trials involving azeliragon, including the Part B Study and the open-label extension study were terminated, although the majority of patients in the Part B Study had at least 12 months’ worth of data at the time of closure. In June 2018, topline efficacy results from the Part B Study were announced showing that the study also failed to meet either of the co-primary endpoints.

Forward-Looking Statements

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Source: vTv Therapeutics Inc.

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