Breakthrough Therapy Status Granted for Type 1 Diabetes Adjunctive Therapy

Breakthrough Therapy for T1Ds

Effectively managing blood glucose levels can be challenging for individuals with type 1 diabetes. Everyone’s body responds differently to various therapeutic treatments; what works well for one person may not be as effective for the next. Researchers are constantly searching for new options to tailor treatment and maintain better control over blood glucose.

Glucokinase activators have been a focus of recent research, as they are commonly used in some treatments for type 2 diabetes. The glucokinase gene acts as a sensor to alert the pancreas to produce more insulin when blood glucose levels rise. However, now they have been found to be potentially effective as an adjunctive therapy to insulin for individuals with type 1 diabetes.

TTP399, an “investigational oral, hepatoselective glucokinase activator,” developed by vTv Therapeutics, Inc. received a Breakthrough Therapy designation by the U.S. Food and Drugs Administration (FDA). The molecule targets hepatic glucokinase rather than pancreatic beta cells. The results of a 12-week phase 2 trial showed that participants who were treated with TTP399 showed improved HbA1c levels, fewer incidences of severe hypoglycemia, and fewer reports of abnormal serum and urine ketones than the control group who received a placebo.

Steve Holcombe, vTv CEO, notes, “Patient and prescriber fear of hypoglycemia often precludes tight glycemic control, and this FDA designation highlights the potential of TTP399 to address this serious unmet medical need.” Additional clinical trials will be conducted later in 2021.

The Diabetes Research Connection (DRC) is excited to see how this breakthrough therapy will impact type 1 diabetes treatment moving forward and what future clinical trials will show. Though not associated with this study, the DRC is committed to supporting T1D research by providing critical funding to early-career scientists. Funding is essential to continue advancing treatment options and one day finding a cure for type 1 diabetes. To learn more, visit http://localhost/drc

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