vTv Therapeutics Inc. (VTVT) stock declined by 6.55% at the last trading close whereas the VTVT stock price surges by 29.57% in the current market trading session. vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focusing on the development of small molecule drug candidates for oral administration. vTv has a list of clinical drug candidates, with programs for type 1 diabetes and psoriasis leading the way. Additional indications in type 2 diabetes, chronic obstructive pulmonary disease, renal disease, and primary mitochondrial myopathy are being pursued by vTv’s development partners.
What is happening?
TTP399 has been granted Breakthrough Therapy status by the US Food and Drug Administration (FDA) as an adjunctive treatment to insulin for the cure of type 1 diabetes. TTP399 is an investigational once-daily glucokinase activator that is administered orally.
The FDA designates an investigational therapy as a breakthrough therapy if preliminary clinical evidence suggests that it can show meaningful progress on one or more significant endpoints compared to available therapies for a severe or life-threatening disorder. Once approved, the Breakthrough Therapy designation provides a sponsor with additional resources and the ability to accelerate the discovery and evaluation of a promising new investigational drug.
The recent positive results from the phase 2 SimpliciT-1 Study, a multi-center, randomized, double-blind, adaptive study evaluating the safety and effectiveness of TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes, backed up the Breakthrough Therapy designation for TTP399 in type 1 diabetes. TTP399 treatment resulted in a statistically significant increase in HbA1c compared to placebo, as well as a clinically meaningful reduction (40%) in the incidence of serious and symptomatic hypoglycemia in this study. TTP399 had a better safety profile than placebo, with elevated levels of serum or urine ketones found less often in TTP399 patients than in placebo patients.
This FDA Breakthrough Therapy designation is a significant step forward in the advancement of TTP399 for the treatment of type 1 diabetes, a debilitating, life-threatening, and life-long disease that affects more than a million Americans on a daily basis,” said Steve Holcombe, vTv’s chief executive officer.