Shares of vTv Therapeutics (Nasdaq: VTVT) skyrocketed as much as 84.8% to $3.88 pre-market on robust volume, as the US clinical-stage drug developer released positive results from Part 2 of a Phase II clinical trial, Simplici-T1, evaluating TTP399 as oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D).
The 12-week trial investigated the efficacy and safety of 800mg of TTP399 compared with placebo in 85 people with type 1 diabetes on optimized insulin therapy. The study was conducted with support from JDRF International (JDRF), the leading provider of T1D research funding globally.
The trial successfully achieved its primary objective analyzed using two statistical approaches to evaluating the effect of TTP399. The primary statistical analysis evaluated the effect on HbA1c regardless of treatment adherence or notable changes in insulin administration. Under the primary statistical analysis, the trial achieved its primary objective by demonstrating statistically-significant improvements in HbA1c (long-term blood sugar) for TTP399 compared to placebo at week 12 (p=0.03).
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