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.
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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.