vTv’s TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with T1D to reduce the occurrence of hypoglycemic episodes. TTP399 restores the normal function of the liver in the presence of high glucose by trapping glucose inside liver cells, promotes further glucose uptake for energy and storage, and keeps the liver in a “fed” state to prevent ketone production.

In its phase 2 study with T1D patients, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo when used as adjunctive treatment to insulin therapy, as well as meaningful improvement to HbA1C. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of T1D. This past October, vTv announced results of a mechanistic study of TTP399 in patients with T1D demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects and demonstrated a good safety and tolerability profile.

TTP399 will be studied in additional clinical trials to be initiated in 2023