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Recently, relevant pharmaceutical companies announced that the US FDA has granted TTP399 "Breakthrough Therapy" qualification.
Such drugs are developed as an adjuvant insulin treatment plan for the treatment of type 1 diabetes.
What is TTP399? TTP399 is a type of glucokinase activator (GKa), which is an oral drug that can selectively target liver GK without destroying the GKRP/GK interaction.
In animal models and patients with type 2 diabetes, TTP399 can improve blood glucose control (mainly driven by lowering blood glucose levels after meals) without increasing the risk of hypoglycemia, elevated triglyceride levels, or liver fat.
The results of the recently announced Phase 2 SimpliciT1 trial showed that in the 12-week trial, compared with placebo plus insulin, TTP399 plus insulin can further improve the HbA1c of adult patients with type 1 diabetes (compared with the placebo group, this group HbA1c decreased by 0.
32% at 12 weeks) and did not increase the risk of hypoglycemia or ketosis.
What can TTP399 bring to the treatment of type 1 diabetes? Regarding the significance of TTP399 in the treatment of type 1 diabetes, some scholars said: “Fear of hypoglycemia is an important reason that hinders people from achieving blood sugar goals, and TTP399 can help patients improve blood sugar control without increasing the risk of hypoglycemia.
Very important".
What does it mean to qualify for "breakthrough therapy"? "Breakthrough Therapy" was created by the US FDA in July 2012.
It originated from a new designation in Article 902 of the US Food and Drug Administration Safety and Innovation Act (FDASIA), aimed at accelerating the development and review of treatments.
New drugs for serious or life-threatening diseases.
This review method was used for the first time in 2013 to speed up drug approval.
For the determination of breakthrough therapy, the preliminary clinical trial evidence must show that the drug can prove that the drug has "substantial improvement" at one or more "clinically meaningful" endpoints, and this depends on the degree of therapeutic effect (such as effectiveness) Duration) and the importance of the observed clinical outcome.
If a new drug under development is approved by the FDA as a breakthrough therapy, it can enjoy the following "treatments": ➤All the privileges enjoyed by fast-track drugs; ➤Get the careful guidance of FDA officials from the phase I clinical stage; ➤including senior management The organization’s commitments, including the
Reference materials: [1] www.
fda.
gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
Recently, relevant pharmaceutical companies announced that the US FDA has granted TTP399 "Breakthrough Therapy" qualification.
Such drugs are developed as an adjuvant insulin treatment plan for the treatment of type 1 diabetes.
What is TTP399? TTP399 is a type of glucokinase activator (GKa), which is an oral drug that can selectively target liver GK without destroying the GKRP/GK interaction.
In animal models and patients with type 2 diabetes, TTP399 can improve blood glucose control (mainly driven by lowering blood glucose levels after meals) without increasing the risk of hypoglycemia, elevated triglyceride levels, or liver fat.
The results of the recently announced Phase 2 SimpliciT1 trial showed that in the 12-week trial, compared with placebo plus insulin, TTP399 plus insulin can further improve the HbA1c of adult patients with type 1 diabetes (compared with the placebo group, this group HbA1c decreased by 0.
32% at 12 weeks) and did not increase the risk of hypoglycemia or ketosis.
What can TTP399 bring to the treatment of type 1 diabetes? Regarding the significance of TTP399 in the treatment of type 1 diabetes, some scholars said: “Fear of hypoglycemia is an important reason that hinders people from achieving blood sugar goals, and TTP399 can help patients improve blood sugar control without increasing the risk of hypoglycemia.
Very important".
What does it mean to qualify for "breakthrough therapy"? "Breakthrough Therapy" was created by the US FDA in July 2012.
It originated from a new designation in Article 902 of the US Food and Drug Administration Safety and Innovation Act (FDASIA), aimed at accelerating the development and review of treatments.
New drugs for serious or life-threatening diseases.
This review method was used for the first time in 2013 to speed up drug approval.
For the determination of breakthrough therapy, the preliminary clinical trial evidence must show that the drug can prove that the drug has "substantial improvement" at one or more "clinically meaningful" endpoints, and this depends on the degree of therapeutic effect (such as effectiveness) Duration) and the importance of the observed clinical outcome.
If a new drug under development is approved by the FDA as a breakthrough therapy, it can enjoy the following "treatments": ➤All the privileges enjoyed by fast-track drugs; ➤Get the careful guidance of FDA officials from the phase I clinical stage; ➤including senior management The organization’s commitments, including the
Reference materials: [1] www.
fda.
gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
