Clinical-stage pharmaceutical company focused on treating metabolic diseases, vTv Therapeutics Inc. (VTVT:NASDAQ), today announced "positive results from Part 2 of the Phase 2 Simplici-T1 trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D). TTP399 is a novel, liver-selective glucokinase activator taken once a day."
The company reported that TTP399 achieved the primary objective in the trial of a statistically significant reduction in HbA1c, without increases in hypoglycemia or ketoacidosis. The firm indicated that the Phase 2 Simplici-T1 Study is a multi-center, randomized study conducted with support from JDRF International (JDRF), the leading provider of T1D research funding globally. The 12-week double-blind clinical trial was designed to investigate the efficacy and safety of TTP399 versus placebo in 85 people with type 1 diabetes on optimized insulin therapy. The firm advised that TTP399 was well tolerated in the study and had no reports of diabetic ketoacidosis in either of the treatment or control group.
Dr. John Buse, Director of the North Carolina Translational and Clinical Sciences Institute and of the Diabetes Center at the University of North Carolina School of Medicine and principal investigator for this study commented, "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."
JRDF's Vice President of Research Sanjoy Dutta, Ph.D. added, "The development of a safe and effective therapy that improves glucose control is a critical step toward eliminating the dangerous highs and lows associated with type 1 diabetes...The results from the Simplici-T1 trial indicate that TTP339 is a promising oral treatment option to help people with type 1 diabetes keep their HbA1c levels within a healthy range, and stay in a desirable glucose range for most of the day, while simplifying the daily management of the disease."
The company's President and CEO Steve Holcombe remarked, "Roughly 1.5 million people in the US are living with type 1 diabetes and the burdensome, around the clock disease management it requires to avoid life-threatening complications. These patients and their families are demanding new treatment options that offer simple, predictable diabetes management to improve HbA1c and time in range. 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...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."
The company explained in the report that "type 1 diabetes is an autoimmune disease in which a person's pancreas stops producing insulin, a hormone that enables people to get energy from food." The firm noted that presently there are no preventative steps that can be taken by those effected, nor are there any existing cures for the disease.
vTv Therapeutics Inc. is a clinical-stage pharmaceutical firm based in High Point, N.C. which focuses on treating metabolic diseases. The company's product pipeline includes small molecule clinical and pre-clinical drug candidates for use in treatment of type 1 diabetes and Alzheimer's disease.
vTv Therapeutics has started the day with a market capitalization of around $125.8 million with approximately 59.9 million shares outstanding. VTVT shares opened greater than 80% higher today at $3.84 (+$1.74, +82.86%) over Friday's $2.10 closing price and established a new 52-week high price this morning of $4.23. The stock has traded today between $3.03 to $4.23 per share and is currently trading at $3.24 (+$1.14, +54.29%).
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