vTv Therapeutics Announces Publication in Diabetes Care of Results from SimpliciT-1 Study of TTP399 in Patients with Type 1 Diabetes
vTv Therapeutics Inc. (Nasdaq: VTVT) announced promising results from the JDRF-supported SimpliciT-1 Study published in Diabetes Care. The study evaluated the safety and efficacy of TTP399, a glucokinase activator, in adults with type 1 diabetes (T1D). Findings showed a statistically significant reduction in HbA1c and a clinically meaningful 40% decrease in severe hypoglycemic events compared to placebo. The results suggest TTP399's potential as a viable adjunctive therapy for T1D, with further studies planned for later this year.
- Significant 40% reduction in severe symptomatic hypoglycemia.
- Statistically significant reductions in HbA1c levels.
- TTP399 demonstrated lower frequency of abnormal serum and urine ketones.
- Potential for TTP399 to enhance glycemic control without increasing risk of ketosis.
- None.
Results found a clinically meaningful decrease in frequency of severe and symptomatic hypoglycemia in addition to statistically significant reductions in HbA1c
HIGH POINT, N.C., Feb. 23, 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 (T1D) and inflammatory diseases, today announced that the results from the JDRF-supported SimpliciT-1 Study were published in the American Diabetes Association’s Diabetes Care journal. 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. TTP399 is a novel, hepatoselective glucokinase activator in development for the reduction of hypoglycemic events in patients 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.
Published results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. Interestingly, it also resulted in a clinically relevant (~
“An adjunctive therapy that protects against the main acute, life-threatening complications of type 1 diabetes while maintaining or improving glycemic control would represent a substantial advancement in clinical standard of care,” said Dr. Carmen Valcarce, vTv’s chief scientific officer. “The data presented in this publication support our enthusiasm and our commitment to continuing the development of TTP399 as an oral adjunctive therapy to insulin in T1D.”
Dr. Klara Klein, MD, PhD, Division of Endocrinology and Metabolism at the University of North Carolina at Chapel Hill, and lead author stated, “The significant improvement in HbA1c, under a stringent treat-to-target design, without an increase in hypoglycemia or blood ketones is a unique observation that, if confirmed in larger studies, reinforces the potential for TTP399 to help people with T1D achieve optimal glycemic control safely.”
The publication, titled “The SimpliciT1 study: A randomized, double-blind placebo-controlled, Phase 1b/2 adaptive study of TTP399, a hepatoselective glucokinase activator, for adjunctive treatment of type 1 diabetes mellitus”, is published online ahead of print at https://care.diabetesjournals.org/lookup/doi/10.2337/dc20-2684.
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 https://vtvtherapeutics.com/ or follow us on Twitter: @vTvTherapeutics.
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