vTv Therapeutics Announces Positive Initial Topline Results from Phase 2b Study of Glucokinase Activator
TTP399 in Type 2 Diabetes
Novel glucokinase activator shows sustained meaningful reduction in HbA1c with well-tolerated treatment
regimen
vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage biopharmaceutical company engaged in discovery and development of new
orally administered treatments for Alzheimer’s disease and diabetes, today announced positive topline results from a placebo and
active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator under development for the
treatment of Type 2 diabetes.
Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6
months of daily administration of 800 mg of TTP399. The reduction in HbA1c was dose-dependent and sustained throughout the duration
of the study. TTP399 was also found to be well-tolerated. Further analysis of the data is ongoing.
“We are extremely pleased with these findings from our Phase 2b study of TTP399,” commented Steve Holcombe, President and CEO of
vTv Therapeutics. “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.”
“We now have a glucokinase activator that appears to improve glucose control in a safe and sustained manner. Although further
studies are necessary, I believe the Phase 2 results suggest that TTP399 may become a significant treatment option in diabetes
care,” said Dr. John Buse, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center
at the University of North Carolina School of Medicine and a member of the vTv Therapeutics Scientific Advisory Board.
The Phase 2b AGATA (Add Glucokinase Activator to Target A1c) study was a six-month,
multicenter, randomized, double-blind, placebo- and active-comparator-controlled, parallel group Phase 2b trial. The primary
endpoint was change from baseline in HbA1c at six months. 190 subjects with Type 2 diabetes were enrolled and randomized into four
arms, and 110 subjects remained in the trial through completion. 26 subjects received a daily dose of 800 mg of TTP399 for the full
six-month course of treatment.
A manuscript with more details is in preparation and will be submitted for publication to a major medical journal.
About Glucokinase and TTP399
Glucokinase (GK) is a key regulator of glucose homeostasis. GK is a genetically validated target. Loss of function mutations in
the gene coding for GK can cause hyperglycemia and Type 2 diabetes.
Activation of GK, a mechanism of action that is distinct from existing Type 2 diabetes treatments, enhances GK activity thereby
improving glycemic control in Type 2 diabetes. Previous attempts to develop GK activators were unsuccessful due to increased
incidence of hypoglycemia, hyperlipidemia, and lack of sustained clinical effect.
TTP399 is an orally bioavailable small molecule GK activator. Unlike previous approaches, TTP399 targets GK activation only in
the liver and does not appear to disrupt the interaction between GK and glucokinase regulatory protein (GKRP), which may lead to
hypoglycemia, limited durability of response and other side effects. TTP399 was discovered by vTv scientists using its proprietary
translational technology platform.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally
administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates
led by programs for the treatment of Alzheimer’s disease and Type 2 diabetes as well as treatment of inflammatory disorders and the
prevention of muscle weakness.
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expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with
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Investors
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Michael Gibralter, 646-378-2938
mgibralter@troutgroup.com
or
Media
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