US-based clinical-stage biopharmaceutical company vTv Therapeutics has reported positive topline results from its Phase IIb clinical trial of TTP399, an orally administered, bio-available, small molecule glucokinase (GK) activator to treat Type 2 diabetes.
TTP399 only activates GK in the liver without disrupting the interaction between GK and glucokinase regulatory protein (GKRP), which may lead to hypoglycemia, limited durability of response and other side effects.
It is based on the patented translational technology platform.
The Phase IIb AGATA (Add Glucokinase Activator to Target A1c) study was been designed as a multicentre, randomised, double-blind, placebo and active-comparator-controlled, parallel group trial held over a period of six months.
The trial involved 190 patients with Type 2 diabetes who were divided into four groups, with 110 subjects remaining through to completion.
During the trial, subjects were administered with 800mg of TTP399 on a daily basis over the six month duration.
The study was primarily focused on determining the baseline change in HbA1c after six months.
Results displayed the primary endpoint's achievement and observed a tolerable profile of TTP399.
vTv Therapeutics president and CEO Steve Holcombe said: “These results show that a glucokinase activator with hepatic selectivity may lead to a meaningful reduction in HbA1c on a sustained basis.
“We are enthusiastic about advancing TTP399 to the next stage of development.”
The researchers are continuing to analyse the data derived from the study.