Lower doses of TTP273 may demonstrate a more pronounced reduction in HbA1c and other key endpoints
HIGH POINT, NC, USA I June 11, 2017 I vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) today announced that results from a Phase 2 clinical study of TTP273, an investigational, oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of Type 2 diabetes, were presented at the American Diabetes Association 77th Scientific Sessions.
In a poster presentation titled, “Is Less More? Learning to dose the oral, non-peptide GLP-1R Agonist, TTP273 in Type 2 Diabetics,” researchers from vTv reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight and fasting plasma glucose. The characteristics of TTP273 (functionally biased and neuro-endocrine signaling) provide a potential scientific rationale supporting the concept that for TTP273, less may be more.
“Further analysis of the Phase 2 data has highlighted a trend where a lower dose shows more pronounced effects,” said Steve Holcombe, president and chief executive officer of vTv Therapeutics. “While additional clinical investigation is needed to confirm the optimal dose for TTP273, we are enthusiastic about TTP273’s potential to meaningfully expand the treatment options for patients with Type 2 diabetes.”
TTP273-201 is a 12-week, multi-center Phase 2, double-blind, placebo-controlled randomized study of 174 patients with Type 2 diabetes on stable doses of metformin who were randomized to either placebo or TTP273 (150 mg once (QPM) or twice (BID) daily). Baseline characteristics were well balanced amongst groups with an overall mean age of 56 years, mean HbA1c of 8.6% and mean BMI of 32 kg/m2. TTP273 was well tolerated with no severe hypoglycemia adverse events (AEs). The most common TEAE was diarrhea, mostly mild in intensity, with only one subject discontinued due to mild diarrhea (150 mg BID). Less nausea was observed in active groups than placebo and the only incidence of vomiting occurred with placebo dosing. Once daily dosing of TTP273 demonstrated placebo-subtracted decrease from baseline of 0.9% in HbA1c and 0.9 kg in weight.
A copy of the presentation will be made available in the News & Events section of the Company’s website following the presentation.
About TTP273
TTP273 is an oral small molecule that works by activating the GLP-1 receptor. Activation of the GLP-1 receptor leads to the enhancement of insulin secretion and suppression of glucagon production and decreased food intake.
There are currently several marketed injectable GLP-1 therapies. These agents have demonstrated notable glucose lowering in addition to weight loss; however, their widespread use may be hindered by the route of administration (injection) and by the high incidence of gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use insulin properly to control sugar in the bloodstream. Type 2 diabetes represents up to 95% of diabetes patients, imposing a growing burden on healthcare systems globally. Diabetes remains the 7th leading cause of death in the United States, costing the healthcare system $245 billion annually. According to the American Diabetes Association, there are 29.1 million Americans, or 9.3% of the population, living with diabetes.
About vTv Therapeutics Inc.
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. Last month, vTv announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator (GKA) under development for the treatment of Type 2 diabetes.
The Company’s drug candidates were discovered with its high-throughput drug discovery platform, TTP Translational Technology®, which translates the functional modulation of human proteins into safe and effective medicines. For further company information, visit www.vtvtherapeutics.com.
SOURCE: vTv Therapeutics
Post Views: 143
Lower doses of TTP273 may demonstrate a more pronounced reduction in HbA1c and other key endpoints
HIGH POINT, NC, USA I June 11, 2017 I vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) today announced that results from a Phase 2 clinical study of TTP273, an investigational, oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of Type 2 diabetes, were presented at the American Diabetes Association 77th Scientific Sessions.
In a poster presentation titled, “Is Less More? Learning to dose the oral, non-peptide GLP-1R Agonist, TTP273 in Type 2 Diabetics,” researchers from vTv reviewed results from a concentration/effect analysis on the LOGRA study showing that lower doses of TTP273 may show more pronounced effects for key efficacy endpoints, including a reduction in HbA1c, weight and fasting plasma glucose. The characteristics of TTP273 (functionally biased and neuro-endocrine signaling) provide a potential scientific rationale supporting the concept that for TTP273, less may be more.
“Further analysis of the Phase 2 data has highlighted a trend where a lower dose shows more pronounced effects,” said Steve Holcombe, president and chief executive officer of vTv Therapeutics. “While additional clinical investigation is needed to confirm the optimal dose for TTP273, we are enthusiastic about TTP273’s potential to meaningfully expand the treatment options for patients with Type 2 diabetes.”
TTP273-201 is a 12-week, multi-center Phase 2, double-blind, placebo-controlled randomized study of 174 patients with Type 2 diabetes on stable doses of metformin who were randomized to either placebo or TTP273 (150 mg once (QPM) or twice (BID) daily). Baseline characteristics were well balanced amongst groups with an overall mean age of 56 years, mean HbA1c of 8.6% and mean BMI of 32 kg/m2. TTP273 was well tolerated with no severe hypoglycemia adverse events (AEs). The most common TEAE was diarrhea, mostly mild in intensity, with only one subject discontinued due to mild diarrhea (150 mg BID). Less nausea was observed in active groups than placebo and the only incidence of vomiting occurred with placebo dosing. Once daily dosing of TTP273 demonstrated placebo-subtracted decrease from baseline of 0.9% in HbA1c and 0.9 kg in weight.
A copy of the presentation will be made available in the News & Events section of the Company’s website following the presentation.
About TTP273
TTP273 is an oral small molecule that works by activating the GLP-1 receptor. Activation of the GLP-1 receptor leads to the enhancement of insulin secretion and suppression of glucagon production and decreased food intake.
There are currently several marketed injectable GLP-1 therapies. These agents have demonstrated notable glucose lowering in addition to weight loss; however, their widespread use may be hindered by the route of administration (injection) and by the high incidence of gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use insulin properly to control sugar in the bloodstream. Type 2 diabetes represents up to 95% of diabetes patients, imposing a growing burden on healthcare systems globally. Diabetes remains the 7th leading cause of death in the United States, costing the healthcare system $245 billion annually. According to the American Diabetes Association, there are 29.1 million Americans, or 9.3% of the population, living with diabetes.
About vTv Therapeutics Inc.
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. Last month, vTv announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator (GKA) under development for the treatment of Type 2 diabetes.
The Company’s drug candidates were discovered with its high-throughput drug discovery platform, TTP Translational Technology®, which translates the functional modulation of human proteins into safe and effective medicines. For further company information, visit www.vtvtherapeutics.com.
SOURCE: vTv Therapeutics
Post Views: 143
