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.