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EX-99.1 - EX-99.1 - vTv Therapeutics Inc.vtvt-ex991_19.htm

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (date of earliest event reported):  August 10, 2016

vTv Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction

of incorporation)

001-37524

(Commission File No.)

47-3916571
(IRS Employer
Identification No.)

 

4170 Mendenhall Oaks Pkwy

High Point, NC 27265

(Address of principal executive offices)

 

(336) 841-0300

(Registrant’s telephone number, including area code)  

NOT APPLICABLE

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a‑12)

 

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 

Item 8.01Other Events 

On August 10, 2016, vTv Therapeutics Inc. (the “Company”) issued a press release announcing positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator under development for the treatment of Type 2 diabetes.

Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months of daily administration of 800 mg of TTP399. The reduction in HbA1c was dose-dependent and sustained throughout the duration of the study. TTP399 was also found to be well-tolerated. Further analysis of the data is ongoing.

The Phase 2b AGATA (Add Glucokinase Activator to Target A1c) is a six-month, double-blind, placebo- and active-controlled parallel group trial in 190 patients with Type 2 diabetes on a stable dose of metformin. The primary endpoint was change from baseline in HbA1c at six months.  190 subjects with Type 2 diabetes were enrolled and randomized into four arms, and 110 subjects remained in the trial through completion. 26 subjects received a daily dose of 800 mg of TTP399 for the full six-month course of treatment.

A copy of the press release is attached as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.

Description

99.1

Press Release dated August 10, 2016

 


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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

VTV THERAPEUTICS INC.

 

By:

/s/ Rudy C. Howard

Name:

Rudy C. Howard

Title:

Chief Financial Officer

 

Dated: August 10, 2016

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