FDA Designates TTP399 a Breakthrough Therapy for People Living with T1D

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May 4th, 2021

On April 15, 2021 the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for vTv Therapeutics’ TTP399 as an adjunct therapy to insulin for type 1 diabetes (T1D). This designation is intended to expedite the development and review of drugs for serious and life-threatening conditions.

TTP399 is a liver-selective glucokinase (or GK) activator. GK regulates blood sugar levels in the body. When blood-sugar levels rise, activation of GK in the liver stimulates glucose utilization, lowering glucose levels in the blood.

In a JDRF-funded phase II clinical trial called Simplici-T1, TTP399 significantly improved HbA1c in people with T1D. Additionally, trial participants who received TTP399 had reduced insulin doses and lower incidences of hypoglycemia (low blood sugar), and no increase in diabetic ketoacidosis (DKA).

After several human studies in type 2 diabetes, JDRF began funding vTv Therapeutics in 2017 to test TTP399 in people with T1D. These positive topline results from the phase II clinical trial follow similarly positive results obtained in a previous smaller clinical study reported by JDRF in June, 2019.

The next step will be upcoming pivotal trials and a study to test the effects of TTP399 on diabetic ketoacidosis (DKA).

This is an exciting development in research focused on improving lives for people living with T1D today. JDRF Canada will keep on top of the latest research results for potential impact to Canadians with T1D.

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