vTv Therapeutics Announces Publication in Diabetes Care of Results from SimpliciT-1 Study of TTP399 in Patients with Type 1 Diabetes
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 (~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. vTv looks forward to initiation of its first pivotal study of TTP399 later this year.
“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.”