VTV Therapeutics Shares Hit 16-Month High After Diabetes Drug Aces Midphase Study

Shares of micro-cap biotech vTv Therapeutics Inc VTVT were advancing to their highest level since October 2018 Monday following a clinical readout from the company.

Success In Phase 2 For VTV Therapeutics

High Point, North Carolina-based vTv said part two of the Phase 2 Simplici-T1 trial achieved the primary objective of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis, at week 12.

The study is evaluating TTP399 as an oral adjunctive therapy to insulin in adults with Type 1 diabetes. 

TTP399 is a liver-selective glucokinase activator taken once a day.

The study, which evaluated 85 type 1 diabetes patients on optimized insulin therapy, studied the efficacy and safety of the experimental drug at 800mg dose relative to placebo.

TTP399 was well-tolerated, with similar incidences of treatment-emergent adverse events overall and by system organ class in both treatment groups, the company said.

Big Win For Type 1 Diabetes Care

"I am very pleased that part 2 of the study confirmed the positive results and effects we saw in part 1. A once-a-day pill that reduces HbA1c and improves time in range with continuous glucose monitoring, without increasing hypoglycemia or any signal for adverse events, is a big win for the future care of type 1 diabetes," Dr. John Buse, a clinical diabetologist, said in a press release. 

About 1.5 million people in the U.S. live with type 1 diabetes, requiring round-the-clock monitoring and management to avoid life-threatening complications, according to vTv Therapeutics.

"Consistent with FDA guidance, a 0.3% improvement in HbA1c is considered clinically meaningful, and coupled with the well-controlled population of patients and favorable safety data from our clinical trials to date, this provides a strong basis for moving this potential first-in-class program forward," CEO Steve Holcombe said in a statement.

The company said it plans to engage with the FDA as soon as possible to plan an efficient development pathway. It expects to initiate a registrational trial this year.

At last check, vTv shares were skyrocketing 56.95% to $3.30 on volume significantly above their average.

Related Links:

The Week Ahead In Biotech: SMID-Cap Earnings In The Spotlight

13 Key NASH Drug Candidates To Watch For In A Potential $30-Billion Market