vTv Therapeutics to Present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases

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

HIGH POINT, N.C.--()--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 14th 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

This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.

Contacts

Investors:
vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or
Media:
Josh Vlasto
212-572-5969
PR@vtvtherapeutics.com

Release Summary

vTv Therapeutics to present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases.

Contacts

Investors:
vTv Therapeutics Inc.
IR@vtvtherapeutics.com
or
Media:
Josh Vlasto
212-572-5969
PR@vtvtherapeutics.com