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▎ WuXi AppTec content team editors recently, vTv Therapeutics announced that its research oral glucokinase (glucokinase) activator TTP399 has been granted a breakthrough therapy designation by the FDA as an adjuvant therapy for insulin to treat patients with type 1 diabetes.
Type 1 diabetes is an autoimmune disease in which the patient's immune system attacks and damages insulin-producing cells, causing the pancreas to stop producing insulin.
These patients need to inject insulin every day to maintain their blood sugar levels.
However, if insulin is injected too much, it may cause severe hypoglycemia, which is a serious complication that may endanger the patient's life.
Glucokinase is one of the key regulators of glucose metabolism balance.
It is like a glucose sensor, which changes its conformation, activity and intracellular distribution as the glucose concentration changes.
It can regulate the level of glucose by regulating the metabolism of glucose in the liver, and can regulate the secretion of insulin.
Activated glucokinase has been shown to be effective in normalizing blood glucose levels in animal models of type 1 and type 2 diabetes.
▲Glucokinase activator is a unique strategy for the treatment of patients with type 1 diabetes (picture source: reference [2]) TTP399 is an investigational glucokinase activator that is taken orally once a day.
The award of breakthrough therapy designation is based on the positive results of a randomized double-blind Phase 2 clinical trial.
In this trial, TTP399, as an adjuvant therapy for insulin, significantly improved the patient's glycosylated hemoglobin level compared with placebo.
Moreover, it reduces the frequency of severe and symptomatic hypoglycemia episodes by 40%.
"The award of this breakthrough therapy designation is an important milestone in the development of TTP399.
"VTv CEO Mr.
Steve Holcombe said, "Hypoglycemia is still the leading cause of potential death in patients with type 1 diabetes.
Many patients have poor blood sugar control due to fear of hypoglycemia.
The FDA’s breakthrough therapy designation underscores the potential of TTP399 in addressing this serious unmet medical need.
"Reference: [1] vTv Therapeutics Receives FDA Breakthrough Therapy Designation for TTP399 for the Treatment of Type 1 Diabetes.
Retrieved April 14, 2021, from /2208965/0/en/vTv-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-TTP399-for-the-Treatment-of-Type-1-Diabetes.
html[2] vTv Therapeutics Corporate Presentation.
Retrieved April 14, 2021, from https://ir.
vtvtherapeutics.
com/static-files/cfd4d4b3-2ef2-40b1-9f6f-aed21a9e2902 Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
If you need to get treatment plan guidance , Please go to a regular hospital for treatment.
Type 1 diabetes is an autoimmune disease in which the patient's immune system attacks and damages insulin-producing cells, causing the pancreas to stop producing insulin.
These patients need to inject insulin every day to maintain their blood sugar levels.
However, if insulin is injected too much, it may cause severe hypoglycemia, which is a serious complication that may endanger the patient's life.
Glucokinase is one of the key regulators of glucose metabolism balance.
It is like a glucose sensor, which changes its conformation, activity and intracellular distribution as the glucose concentration changes.
It can regulate the level of glucose by regulating the metabolism of glucose in the liver, and can regulate the secretion of insulin.
Activated glucokinase has been shown to be effective in normalizing blood glucose levels in animal models of type 1 and type 2 diabetes.
▲Glucokinase activator is a unique strategy for the treatment of patients with type 1 diabetes (picture source: reference [2]) TTP399 is an investigational glucokinase activator that is taken orally once a day.
The award of breakthrough therapy designation is based on the positive results of a randomized double-blind Phase 2 clinical trial.
In this trial, TTP399, as an adjuvant therapy for insulin, significantly improved the patient's glycosylated hemoglobin level compared with placebo.
Moreover, it reduces the frequency of severe and symptomatic hypoglycemia episodes by 40%.
"The award of this breakthrough therapy designation is an important milestone in the development of TTP399.
"VTv CEO Mr.
Steve Holcombe said, "Hypoglycemia is still the leading cause of potential death in patients with type 1 diabetes.
Many patients have poor blood sugar control due to fear of hypoglycemia.
The FDA’s breakthrough therapy designation underscores the potential of TTP399 in addressing this serious unmet medical need.
"Reference: [1] vTv Therapeutics Receives FDA Breakthrough Therapy Designation for TTP399 for the Treatment of Type 1 Diabetes.
Retrieved April 14, 2021, from /2208965/0/en/vTv-Therapeutics-Receives-FDA-Breakthrough-Therapy-Designation-for-TTP399-for-the-Treatment-of-Type-1-Diabetes.
html[2] vTv Therapeutics Corporate Presentation.
Retrieved April 14, 2021, from https://ir.
vtvtherapeutics.
com/static-files/cfd4d4b3-2ef2-40b1-9f6f-aed21a9e2902 Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
If you need to get treatment plan guidance , Please go to a regular hospital for treatment.
