Led by Klara Klein, MD, PhD, the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c and clinically relevant reduction in the frequency of severe or symptomatic hypoglycemia.
Today, vTv Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D) and inflammatory diseases, 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.
This 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 (~40%) reduction in the frequency of severe or symptomatic hypoglycemia, as compared to placebo. Abnormal serum and urine ketones were 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.
“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 the treatment of type 1 diabetes.,” 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.”
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 more 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”, was published today online ahead of print.
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.
Media contact: PR@vtvtherapeutics.com
UNC School of Medicine contact: Mark Derewicz, 984-974-1915