vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), today announced that the results from the JDRF-supported mechanistic study assessing effects of TTP399 on ketones during acute insulin withdrawal were published in the Diabetes Obesity and Metabolism journal and presented at The American Diabetes Association's 82^nd Scientific Sessions (#ADA2022) on June 5^th.

This Phase 1, mechanistic study evaluated the effects of the GKA TTP399 on ketoacidosis risk in individuals with T1D on insulin pump therapy. The primary goal was to assess safety of TTP399 via a primary endpoint of non-inferiority of TTP399 compared to placebo regarding ketone levels during acute insulin withdrawal (IWT). Indeed, TTP399 did not alter circulating concentrations of beta-hydroxybutyrate (BOHB) or time to cessation of IWT and confirmed non-inferiority. Pre-specified secondary analyses investigated the potential for benefit. No subject treated with TTP399 met the prespecified definition of DKA while 42% of placebo-treated subjects met this criterion. Together, these data suggest that TTP399 does not increase, and may decrease, the risk of diabetic ketoacidosis (DKA) in subjects with T1D.

This finding stands in direct contrast to other promising oral adjunctive therapies tested in T1D. During similar insulin withdrawal experiments, SGLT2i use significantly increased ketonemia in people with T1D during insulin withdrawal¹. Moreover, off-label use of SGLT2i in the real world is associated with substantially increased risk of euglycemic DKA². That TTP399 did not result in increased BOHB during acute insulin withdrawal and instead demonstrated a trend toward lowering risk of metabolic acidosis suggests that TTP399 will not increase the risk of DKA when used in the real world.

The data from this study support prior studies that demonstrate that TTP399 improves glucose control and reduces hypoglycemia and suggest a protective effect of TTP399 against acidosis in people with T1D.

“There is an urgent need to develop adjunctive therapies to improve metabolic control in people with type 1 diabetes,” said Jonathan Rosen, JDRF Associate Director of Research. “This mechanistic study showing that TTP399 did not raise ketone levels relative to placebo adds to the body of data arguing that vTv’s liver-selective glucokinase activator has promise to be a safe, effective therapy for type 1 diabetes.”

The publication, titled “Impact of the Hepatoselective Glucokinase Activator TTP399 on Ketoacidosis During Insulin Withdrawal in People with Type 1 Diabetes,” will be available online ahead of print on June 4th at 10am CDT at:

https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14697

¹ Herring et al, Diabetes Care 2020 https://doi.org/10.2337/dc19-2579
² Peters et al, Diabetes Care. 2015 https://doi.org/10.2337/dc15-0843

About TTP399

TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with type 1 diabetes. In a recent phase 2 clinical trial, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of type 1 diabetes. This past October, vTv announced results of a mechanistic study of TTP399 in patients with type 1 diabetes demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects. TTP399 is still in the development phase; the FDA has not reviewed or approved TTP399 for use in the United States.

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 cystic fibrosis related diabetes. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, primary mitochondrial myopathy, and pancreatic cancer.

For more information, please visit www.vtvtherapeutics.com.

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