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vTv Therapeutics Announces Positive Results from Mechanistic Study Indicating No Increased Risk of Ketoacidosis with TTP399 during Acute Insulin Withdrawal in Patients with Type 1 Diabetes
Study achieved primary endpoint of non-inferiority on measurement of key blood ketone levels Patients taking TTP399 reported no events of hypoglycemia, while
About this update from Vtv Therapeutics Inc.
[{"type":"text","content":"Study achieved primary endpoint of non-inferiority on measurement of key blood ketone levels Patients taking TTP399 reported no events of hypoglycemia, while four events of hypoglycemia were reported in the placebo arm Start-up activities for Phase 3 program ongoing with trials expected to begin in early 2022 HIGH POINT, N.C., Oct. 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 psoriasis, today announced positive results of a mechanistic study of TTP399 in patients with type 1 diabetes (T1D). The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis. Consistent with previous clinical studies, improved fasting plasma glucose levels and fewer hypoglycemic events were observed in the TTP399 treated group during the week of treatment prior to the insulin withdrawal test. The U.S. Food and Drug Administration (FDA) has declined to approve SGLT2 inhibitors as an adjunctive therapy in T1D, with concerns over the potential risks of diabetic ketoacidosis (DKA) in focus. DKA can lead to hospitalization and, if untreated, death. In order to address these concerns, vTv, following the FDA’s recommendation, conducted this mechanistic study to demonstrate that treatment with TTP399, a liver-selective glucokinase activator, will not result in increased production of ketones, a precursor to ketoacidosis. “This mechanistic study confirms the hypothesis that treatment with TTP399 lowers glucose, results in less hypoglycemia, and does not increase the formation of ketones” said Jeremy Pettus, MD, Assistant Professor of Medicine, University of California, San Diego and an investigator for the study. “These results overcome a major hurdle faced by other potential adjunct therapies, particularly those from the SGLT2 class.” “The results from this trial suggest that TTP399 can lower blood glucose without increasing the risk of DKA,” said Jonathan Rosen, PhD, Associate Director of Research at JDRF. “This is so important because DKA remains a challenge in people with type 1 diabetes and insulin by itself is not enough for most people with T1D to achieve optima...