Exhibit 99.1

 

 

 

 

 

vTv Therapeutics Announces 2020 Fourth Quarter and Full Year Financial Results and Provides Corporate Update

 

Initiation of Mechanistic Study of TTP399 expected during Q1 2021

 

Announcement of First-Patient First-Visit in Multiple Ascending Dose Phase 1 Study of HPP737

 

Publication of Phase 2 SimpliciT-1 Results of TTP399 in ADA’s Diabetes Care Journal

 

HIGH POINT, N.C. – (GLOBE NEWSWIRE) – February 24, 2021 –

vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the fourth quarter and year ended December 31, 2020, and provided an update on the progress of its clinical programs.

 

“Despite the challenges of operating through a global pandemic, 2020 was a successful year for vTv Therapeutics,” said Steve Holcombe, president and CEO. “We had positive results in the Phase 2 SimpliciT-1 Study with our lead compound, TTP399, paving the way for our continued development of this asset in patients with type 1 diabetes. In addition, we strengthened our current and future financial position with the initiation of our ATM, agreement with Lincoln Park Capital, and licensing agreement with Anteris Bio.”

 

“In 2021, we look forward to building on these successes as we advance our two lead programs for the treatment of type 1 diabetes and psoriasis. We plan to initiate our first pivotal study of TTP399 along with other supporting studies to demonstrate our unique glucokinase activator’s potential to reduce the incidence of hypoglycemia in people with type 1 diabetes. Furthermore, we have commenced a multiple ascending dose study with HPP737 to be followed by a phase 2 study in patients with psoriasis in order to demonstrate HPP737’s potential to be a well-tolerated, next-generation PDE4 inhibitor.”

 

Recent Achievements and Outlook

 

Type 1 Diabetes

 

 

Mechanistic Study of Ketoacidosis with TTP399.  To further support the hypothesis that TTP399 may help reduce the incidence of ketoacidosis, vTv will begin dosing of a mechanistic study of TTP399 in patients with type 1 diabetes during Q1 of 2021 to determine the impact of TTP399 on ketone body formation during a period of acute insulin withdrawal.  The  FDA agreed with the Company’s recommendation that such a mechanistic study be performed in support of the Company’s planned pivotal trials. vTv expects to report topline results from the mechanistic study in Q2/Q3 2021.

 

 

Pivotal Study Planning.  The Company is planning to initiate the first of two pivotal, placebo-controlled, six-month clinical trials of TTP399 in approximately 400 subjects with type 1 diabetes in 2H 2021.  The studies will be designed to assess TTP399’s ability to reduce the incidence of hypoglycemia when administered as an oral adjunct to insulin therapy.

 

 


The following information was filed by Vtv Therapeutics Inc. (VTVT) on Wednesday, February 24, 2021 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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