Exhibit 99.1

 

 

 

 

 

vTv Therapeutics Announces 2020 Second Quarter Financial Results and Update

 

HIGH POINT, N.C. – (BUSINESS WIRE) – August 3, 2020 –

vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30, 2020, and provided an update on the progress of its clinical programs.

 

“Building on the successful phase 2 study completed earlier this year with TTP399, we have been highly focused on advancing this promising candidate as an adjunct to insulin for type 1 diabetes into the next stage of clinical development,” said Steve Holcombe, president and CEO. “To this end, we have been engaging with the FDA to determine the development path for TTP399 and are in the planning stages for our first pivotal study, which we anticipate commencing by the end of 2020.  We have also continued to enroll patients in our phase 2 study of azeliragon for the treatment of Alzheimer’s disease in patients with type 2 diabetes, despite the clinical challenges posed by COVID-19.”

 

Recent Achievements and Outlook

 

Type 1 Diabetes

 

 

FDA Engagement and Pivotal Study Planning.  Following a Type C Meeting request, vTv received written feedback from the FDA in June regarding the design of the Company’s proposed pivotal studies.  vTv expects to commence the next study for TTP399 by the end of 2020 with a six-month treatment period and a six-month open label extension.  A second study with a 6-month treatment period would be initiated within 12 months after initiation of the first trial.

 

 

Two Presentations at ADA of SimpliciT-1 Study Results.  Dr. John Buse, University of North Carolina at Chapel Hill, and Dr. Carmen Valcarce, chief scientific officer, made separate presentations at the American Diabetes Association’s 80th Scientific Sessions on the results of the Simplici-T1 Study in which TTP399 improved HbA1c in patients with type 1 diabetes, while reducing insulin dose and lowering the incidence of hypoglycemia and diabetic ketoacidosis.

 

Dementia with Diabetes

 

 

Enrollment continues for Phase 2 Elevage Study of azeliragon. vTv continues to enroll patients in the Elevage Study to evaluate the efficacy and safety of azeliragon in patients with probable mild Alzheimer's disease (AD) and type 2 diabetes. Recruitment for the study will conclude by September 30, 2020 with a target of approximately 50 patients enrolled. The Company expects to report topline results from this study in the second quarter of 2021.

 

 

Additional Clinical Data from STEADFAST Presented at AAIC. Dr. Aaron Burstein, SVP clinical development, presented additional clinical data at the Alzheimer’s Association International Conference of the impact of azeliragon on the individual

 


The following information was filed by Vtv Therapeutics Inc. (VTVT) on Monday, August 3, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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