On April 13, the US FDA granted vTv Therapeutics' research drug TTP399 the title of breakthrough therapy for type 1 diabetes (T1D). The designation of this title provides the company with the possibility of shortening the development and review time. vTv Therapeutics looks forward to cooperating with the US FDA to advance the research and development of TTP399, especially when it will start a key clinical trial later this year.

It is reported that TTP399 is an adjuvant therapy for insulin treatment of type 1 diabetes. It is an innovative, oral, once-daily glucokinase activator.

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. vTv Therapeutics published the results of this study in the Journal of Diabetes Care of the American Diabetes Association on February 23 this year. The trial is divided into two parts, using a treatment-targeting program. After multiple weeks of insulin optimization and a placebo run-in period, the safety and efficacy of T1D patients' medication for 12 weeks were studied.

The data showed 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%. Compared with the placebo group, patients in the TTP399 group also had fewer abnormal serum and urine ketone levels.

T1D is an autoimmune disease. In this disease, a person’s pancreas stops secreting insulin because the body’s immune system attacks and destroys the insulin-secreting cells in the pancreas, known as beta cells. Once, T1D was called juvenile or childhood diabetes, and type 2 diabetes was called adult diabetes. Although some patients with type 2 diabetes progress to insulin therapy, there are alternatives to insulin. Weight loss, proper diet and exercise can also help control type 2 diabetes. The onset of T1D is different from type 2 diabetes and has nothing to do with diet or lifestyle, so there are not many ways to prevent or treat the disease.

Reference source: FDA Grants vTv’s Type 1 Diabetes Drug Breakthrough Therapy Designation