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news.Biopharmaceutical firm vTv Therapeutics has started dosing in its Phase IIb clinical trial (AGATA study) of TTP399, an oral liver-selective Glucokinase Activator (GKA), to treat patients with type 2 diabetes.
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The AGATA study is designed to evaluate the safety and efficacy of TTP399 following six months administration in subjects with type 2 diabetes mellitus on a stable dose of metformin.
Around 180 patients in the US will be enrolled in the multi-center, double-blind, placebo- and active-controlled (sitagliptin) AGATA study. They will be randomized to receive placebo, 400mg or 800mg of TTP399 or 100mg of sitagliptin once daily for six months.
The trial will show that TTP399 produces significant and sustainable improvement in glycemic control.
The primary efficacy endpoint of the trial is change in A1c from baseline to the end of randomized treatment, while key secondary endpoints include changes in lipid parameters and body weight.
Preclinical and clinical data showed that TTP399 normalizes A1c without inducing hypoglycemia. The data encouraged teh company to take the development forward, vTv said.
In a phase IIa trial, TTP399 showed a statistically significant and clinically meaningful reduction in A1c levels compared with placebo after only six weeks of dosing, without induction of hypoglycemia or hyperlipidemia and with no induction of insulin secretion in these patients.
vTv Therapeutics president and CEO Stephen Holcombe said: "Despite the availability of several oral anti-diabetic therapies, a large number of patients with type 2 diabetes do not achieve their recommended A1c target levels.
"Glucokinase (GK) is a physiological glucose-sensor. It is a genetically validated target that has been pursued by the industry for years with many failures due to safety issues and loss of efficacy.
"We have designed TP399 to only activate GK in the liver and not to interrupt the physiological regulation of GK by the GK regulatory protein.
"The data we have generated with TTP399 suggests this approach to GK activation will bypass the common pitfalls associated with other GKAs and has positioned TTP399 as the leader in GK Activators currently in development."