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vTv Therapeutics Announces 2019 Third Quarter Financial Results and Update

Published: 2019-10-30 21:30:00 ET
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SimpliciT-1 Study of TTP399 in patients with type 1 diabetes fully-enrolled

Elevage Study of azeliragon in patients with mild Alzheimer’s disease with type 2 diabetes actively enrolling

HIGH POINT, N.C., Oct. 30, 2019 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the third quarter that ended September 30, 2019, and provided an update on recent achievements, events, and its ongoing clinical trials in type 1 diabetes and Alzheimer’s disease.

“We hosted an informative type 1 diabetes key opinion leader event with JDRF this quarter where two prominent KOLs, Drs. John Buse and Kevan Herold, shared important information including that, despite the increasingly widespread use of improved technologies like continuous glucose monitoring, nearly 80% of individuals with type 1 diabetes fail to achieve the American Diabetes Association’s target goals for HbA1c,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “Based on the data we’ve seen to date in our trial of TTP399 in patients with type 1 diabetes, we believe our glucokinase activator could eventually provide a meaningful treatment option to patients with type 1 diabetes that would lower A1c, improve glycemic control and reduce daily insulin use, without increasing hypoglycemic events.”

“We are also pleased that we are continuing to make progress with the Elevage Study of azeliragon in patients with mild Alzheimer’s disease with type 2 diabetes that is expected to read-out in late 2020 or early 2021.”

Recent Achievements and Outlook

Type 1 Diabetes Study

  • Completed enrollment for Part 2 of the Simplici-T1 Study. In September 2019, we completed enrollment of patients in part 2 of the phase 2 Simplici-T1 Study, a 12-week study to evaluate TTP399 as an adjunct to insulin therapy for patients with type 1 diabetes. We expect to report results in the latter part of the first quarter of 2020. 
  • Presented Additional Positive Data from Part 1 of the Simplici-T1 Study. In September 2019, we presented positive continuous glucose monitor (CGM) and insulin dose data from the patients with complete CGM profiles from part 1 of the Simplici-T1 Study at the 55th Annual Meeting of the European Association for the Study of Diabetes. In addition to the previously presented topline improvement in HbA1c of 0.7% relative to placebo, key results from this presentation included:• Patients taking TTP399 treatment (n=6) had increased “Time in Range” from baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day (24 hours), and by 12% (1.7 hours) (p=0.04) during the critical waking hours (7am-9pm) relative to placebo (n=9).• Patients taking TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving glycemic control.• Patients in the TTP399 treatment group experienced fewer Level 1 (≥54-70 mg/dl) and Level 2 (