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vTv Therapeutics Announces 2021 Second Quarter Financial Results and Provides Corporate Update
HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30,
About this update from Vtv Therapeutics Inc.
[{"type":"text","content":"HIGH POINT, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs. “We held our first, highly-productive meeting with the FDA following the designation of Breakthrough Therapy for TTP399 as a potential adjunct treatment for type 1 diabetes,” said Steve Holcombe, president and CEO, vTv Therapeutics. “Based upon the outcome of this meeting, we are planning to conduct two pivotal studies of TTP399 starting in the first half of 2022. We are appreciative of the ongoing dialogue that the Breakthrough Designation affords us and look forward to continuing to work closely with the agency as we refine the design of these studies in the coming weeks.” Recent Achievements and Outlook Type 1 Diabetes Breakthrough Therapy Designation Type B Meeting. As announced in April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. The Company held its first Type B meeting with the FDA pursuant to the Breakthrough Therapy designation to discuss the development of TTP399.Mechanistic Study of Ketoacidosis with TTP399. The Company completed enrollment in the mechanistic study of TTP399 in people with type 1 diabetes. This phase 1 study is designed to assess the impact of TTP399 on ketone body formation, and therefore the risk of diabetic ketoacidosis, during a period of acute insulin withdrawal. vTv expects to report topline results from this mechanistic study in late third quarter or early fourth quarter of 2021.Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes that are expected to begin in the first half of 2022. Psoriasis Multiple Ascending Dose Study with HPP737. The Company completed dosing healthy subjects in a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, an oral PDE4 inhibitor. We expect to report the results from this study in the third quarter.Phase 2 Study Planning. The Company is planning a phase 2 clinical trial of HPP737 in patients with psoriasis. We are discussing the proposed study design with the FDA during ...