Stock Alert: VTv Therapeutics (VTVT)

(RTTNews) - Shares of vTv Therapeutics Inc. (VTVT) are up over 50 percent in pre-market trading on Monday, following positive results from Part 2 of Simplici-T1 Study, a phase II trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes.

Part 2 of the study is a 12-week trial, which investigated the efficacy and safety of 800 mg of TTP399 against placebo in 85 people with type 1 diabetes on optimized insulin therapy, and it achieved the primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis.

The study was conducted in two parts - Part 1 and Part 2.

In Part I of the study, patients treated with TTP399 showed a statistically significant mean reduction in HbA1c of 0.6% at 12 weeks, while the group treated with placebo showed a mean increase in HbA1c of 0.1%. The results were reported last June.

Part 2 of the study, whose results have been just released, confirms the positive results and effects that were observed in Part 1.

Commenting on the results, Steve Holcombe, President and CEO of vTv Therapeutics, said, "We intend to engage with the FDA as soon, as possible to plan an efficient development pathway for TTP399 and hope to initiate a registration trial this year."

VTVT closed Friday's trading at $2.10, up 4.48%. in pre-market trading on Monday, the stock is up 52.38% at $3.20.