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TTP399 SimpliciT-1 Study Results to be presented at a scientific symposium in celebration of the 100th anniversary of the discovery of insulin

HIGH POINT, N.C., April 12, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced that results from the JDRF-supported SimpliciT-1 Study will be presented at A Scientific Symposium: In celebration of the 100th anniversary of the University of Toronto’s discovery of insulin (Insulin100) held virtually, April 15 & 16, 2021.

The presentation titled “The SimpliciT-1 Study: Hepatoselective Glucokinase Activation Via TTP399 For The Treatment Of Type 1 Diabetes Mellitus" was awarded first place in the symposium’s Post Doc - Clinical Category and earned the opportunity to be presented to the world’s leading experts on type 1 diabetes. Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and Sub-Principal Investigator of the SimpliciT-1 study, will present the data in a 15 minute presentation on April 15th in a session held from 1:10-1:25pm ET. Registration is available here.

The Insulin100 symposium, chaired by Dr. Daniel Drucker of the University of Toronto, celebrates the 100th anniversary of the life-saving discovery of insulin and aims to provide comprehensive updates on the latest advances in diabetes treatment and management.

“We are pleased that vTv’s research in type 1 diabetes is being recognized by the diabetes community,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “We are dedicated to advancing TTP399 and believe that it has the potential to be a new treatment option for type 1 diabetes that improves patients’ lives.”

vTv is currently conducting a mechanistic study exploring the effects of TTP399 on ketone body formation during a period of insulin withdrawal in people with type 1 diabetes and is planning a pivotal trial that will be initiated later this year.

About the SimpliciT-1 Study

The SimpliciT-1 Study was a multi-center, randomized, double-blind, adaptive study assessing the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with T1D. The Phase 2 study was conducted in two parts under a treat-to-target protocol to evaluate the safety and efficacy of TTP399 in T1D patients over 12 weeks of daily dosing following a multi-week insulin optimization and placebo run-in period.

Results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Importantly, it also resulted in a clinically relevant (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. TTP399 exhibited a favorable safety profile, with abnormal serum and urine ketones detected less frequently in participants in the TTP399 group than in the placebo group. These data suggest the potential of TTP399 to lower HbA1c and reduce hypoglycemia without increasing the risk of ketosis and should be further evaluated as an adjunctive therapy for the treatment of type 1 diabetes.

About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit or follow us on Twitter: @vTvTherapeutics.

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Corey Davis
LifeSci Advisors



Source: vTv Therapeutics Inc. 

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Source: vTv Therapeutics Inc.