Press release

Disclosures: Holcombe is CEO of vTv Therapeutics. Valcarce is chief scientific officer of vTv Therapeutics.
April 14, 2021
1 min read

FDA grants breakthrough therapy designation for novel type 1 diabetes pill


Press release

Disclosures: Holcombe is CEO of vTv Therapeutics. Valcarce is chief scientific officer of vTv Therapeutics.
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact

The FDA granted breakthrough therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes, according to a press release from vTv Therapeutics.

TTP399 is an investigational oral, once-daily glucokinase activator. Breakthrough therapy designation is based on FDA’s determination that preliminary clinical evidence indicates that an investigational therapy may demonstrate substantial improvement on one or more significant endpoints relative to available therapies for a serious or life-threatening condition. Once granted, breakthrough therapy designation provides a sponsor with added support and the potential to expedite development and review timelines for a promising new investigational medicine.

FDA sign
Source: Adobe Stock

“This FDA breakthrough therapy designation is an important milestone in the development of TTP399 for the treatment of type 1 diabetes, a serious, life-threatening and lifelong condition impacting the day-to-day lives of more than a million Americans,” Steve Holcombe, CEO of vTv Therapeutics, said in the release. “Hypoglycemia remains a leading cause of morbidity and potential mortality in the treatment of type 1 diabetes. 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. 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.”

As Healio previously reported, findings from the phase 2 Simplici-T1 trial demonstrated that TTP399, when added to optimized insulin therapy, was shown to reduce HbA1c among adults with type 1 diabetes during a 12-week trial when compared with placebo plus insulin. The pill was associated with a placebo-subtracted HbA1c reduction of 0.32% at 12 weeks when compared with placebo.

Carmen Valcarce

“This may be the first adjunctive therapy that can help people improve their glycemic control without increasing the risk for hypoglycemia,” Carmen Valcarce, PhD, chief scientific officer of vTv Therapeutics, told Healio in October when the findings were presented. “Fear of hypoglycemia is what keeps people from achieving their target goals. That is the major take-home message.”

Additional findings from the Simplici-T1 trial showed that TTP399 demonstrated a favorable safety profile, with abnormal levels of serum or urine ketones detected less frequently among participants assigned TTP399 vs. placebo.