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CompileKe Ke
On April 13, the US FDA granted vTv Therapeutics' research drug TTP399 the title of breakthrough therapy for type 1 diabetes (T1D).
It is reported that TTP399 is an adjuvant therapy for insulin treatment of type 1 diabetes.
The award of the breakthrough therapy title is based on the latest positive data from the Phase II clinical study SimpliciT-1, a multi-center, randomized, double-blind, adaptive study that evaluates TTP399 as an adjuvant insulin therapy in the treatment of adult T1D patients.
Data show that compared with placebo, after treatment with 800mg TTP399, the patient's glycosylated hemoglobin (HbA1c) level was statistically significantly reduced; the incidence of severe or symptomatic hypoglycemia (low blood sugar level) was also clinically reduced About 40%.
T1D is an autoimmune disease.
Reference source: FDA Grants vTv's Type 1 Diabetes Drug Breakthrough Therapy Designation
Reference source: FDA Grants vTv's Type 1 Diabetes Drug Breakthrough Therapy Designation