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vTv Therapeutics to Present on Azeliragon at the 10th Clinical Trials on Alzheimer’s Disease (CTAD)

-- Azeliragon is the only receptor for advanced glycation endproducts (RAGE) antagonist in clinical development for Alzheimer’s disease --

HIGH POINT, N.C.--(BUSINESS WIRE)--Oct. 30, 2017-- vTv Therapeutics Inc. (Nasdaq:VTVT), today announced that the Company will present three posters on clinical trials related to its lead investigational Alzheimer’s program candidate, azeliragon, at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) conference on November 1 - 4, 2017 in Boston. vTv is currently studying azeliragon in two identical, randomized, double-blind, placebo-controlled Phase 3 trials investigating its efficacy as a potential treatment of mild Alzheimer’s disease.

Details of the poster presentations are as follows:

Title: Effect of mild or moderate hepatic impairment on the clearance of azeliragon
Poster Number: P30
Category: Clinical trials: Results
Date: Wednesday, November 1 and Thursday, November 2
Location: Georgian Room, Boston Park Plaza Hotel

Title: Effect of CYP2C8 and CYP3A4 inhibition and CYP induction on the pharmacokinetics of azeliragon
Poster Number: P31
Category: Clinical trials: Results
Date: Wednesday, November 1 and Thursday, November 2
Location: Georgian Room, Boston Park Plaza Hotel

Title: Analysis of treatment emergent adverse event incidences in phase 2 study of azeliragon reveal potential attenuation of psychiatric system organ class (SOC) adverse events and expected drug effects in gastrointestinal SOC
Poster Number: P39
Category: Clinical trials: Results
Date: Wednesday, November 1 and Thursday, November 2
Location: Georgian Room, Boston Park Plaza Hotel

“vTv is committed to pursuing innovative, scientific advancement and to our goal of developing a safe and impactful treatment for the Alzheimer’s disease community,” said Steve Holcombe, president and chief executive officer of vTv Therapeutics. “We eagerly anticipate Part A readout of our Phase 3 STEADFAST trial early next year, the next step in our progression toward a potential NDA submission to FDA. We look forward to the prospect of azeliragon as a new therapy that could potentially slow the cognitive and functional decline associated with mild Alzheimer's disease.”

About Azeliragon

vTv 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 activation contributes to the pathogenesis of Alzheimer’s disease. Sustained Amyloid-β interactions with RAGE at the blood-brain barrier (BBB) and in neuronal and microglial cells, play potentially major roles in amyloid plaque formation, neuroinflammation and chronic neural dysfunction – all hallmarks of Alzheimer’s disease. Azeliragon, also known as TTP488, is a novel orally active small-molecule antagonist of RAGE.


STEADFAST, two identical randomized, double-blind, placebo-controlled Phase 3 trials, is investigating the efficacy of azeliragon as a potential treatment to slow the decline in cognition and functional activities for patients with mild Alzheimer’s disease. The 18-month trial targeted enrollment of 800 patients (400 each for Part A and B). Part A enrolled patients in the United States and Canada. Enrollment of Part B additionally included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa. Subjects completing the STEADFAST study are eligible to enroll in a 24-month open-label extension trial. STEADFAST is being conducted following agreement with FDA under the Special Protocol Assessment (SPA) process and the azeliragon development program has been granted fast track designation. Enrollment of Part A was completed in September 2016 with data expected to read out in early 2018. Part B data is expected to read out in late 2018.

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 diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness.

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.

Source: vTv Therapeutics Inc.

vTv Therapeutics Inc.
Mike Biega, 617-221-9660
Pure Communications
Katie Engleman, 910-509-3977