The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TTP399 (vTv Therapeutics, Inc.) as an adjunctive therapy to insulin for the treatment of type 1 diabetes.

TTP399 is an investigational oral, hepatoselective glucokinase activator. The designation is supported by data from the phase 2 SimpliciT-1 study ( NCT03335371) that evaluated the efficacy and safety of TTP399 as an adjunct to insulin in adults with type 1 diabetes for 12 weeks. 

Findings demonstrated that treatment with TTP399 was associated with a statistically significant improvement in HbA1c compared with placebo. Moreover, a clinically meaningful decrease in the frequency of severe and symptomatic hypoglycemia was observed in TTP399-treated patients.

As for safety, TTP399 was found to have a favorable profile. Abnormal levels of serum and urine ketones were reported less frequently in patients taking TTP399 compared with placebo.

“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,” said Steve Holcombe, CEO of vTv. “We look forward to working with the FDA as we advance the development of TTP399, and in particular as we begin pivotal trials later this year.”


vTv Therapeutics receives FDA Breakthrough Therapy designation for TTP399 for the treatment of type 1 diabetes. [press release]. High Point, NC: vTv Therapeutics Inc.; April 13, 2021.