vTv Therapeutics Presents Two Late-Breaking Poster Sessions on Simplici-T1 Study at the American Diabetes Association’s Vir...
14 June 2020 - 1:00AM
vTv Therapeutics Inc. (Nasdaq: VTVT) today made two
presentations at the American Diabetes Association’s 80th
Scientific Sessions. The clinical data presented from the positive
Phase 2 Simplici-T1 Study confirms the potential for TTP399 to
provide a benefit beyond standalone insulin treatment for patients
living with type 1 diabetes.
“These results from the Simplici-T1 Trial are a major step
towards the future of care in type 1 diabetes. They
demonstrate that TTP399, a once-a-day pill, reduces HbA1c and
improves time in range, without increasing hypoglycemia or any
signal for adverse events including diabetic ketoacidosis,” said
John Buse, MD, Director of the North Carolina Translational and
Clinical Sciences Institute and of the Diabetes Center at the
University of North Carolina School of Medicine. “Despite advances
in insulin and type 1 diabetes technologies, affected patients
continue to have difficulty achieving optimal glucose control. A
safe and effective oral adjunctive therapy would be an important
tool for patients and treating endocrinologists to improve both the
daily burden of T1D and its long-term outcomes.”
A copy of the poster presentations is available on the company
website at http://vtvtherapeutics.com/publications/.
Details of the presentations follow:
Late Breaking Poster Presentation: Poster
#122-LB, The Simplici-T1 Trial: Glucokinase Activator TTP399
Improves Glycemic Control in Patients with Type 1 Diabetes.
Presenter: John Buse, M.D., Ph.D., Director of
the North Carolina Translational and Clinical Sciences Institute
and of the Diabetes Center at the University of North Carolina
School of Medicine
Key results presented included:
- Part 2 of the Simplici-T1 Study confirmed the results from Part
1 in a greater number of subjects (n=85) with TTP399 significantly
reducing HbA1c by 0.3% (p<0.01; trial product estimand); 0.2%
(p<0.05; FAS), compared to placebo.
- An analysis conducted with treatment responders found a
significant difference in the number of responders taking TTP399
(42%) vs. those on placebo (12%) (ITT: p<0.01). Treatment
responders were patients that exhibited all of the following:
improved HbA1c, no severe or symptomatic hypoglycemia or increase
in insulin bolus dose >3U/day, and no abnormal
beta-hydroxybutyrate or lactic acid levels.
- Treatment-emergent adverse events were numerically lower in the
TTP399 treatment group, with trends towards reduction in
hypoglycemic and ketone events in the TTP399-treated group.
Late Breaking Poster Presentation: Poster
#123-LB, The Simplici-T1 Trial: Relationship between Glycemic
Control and Insulin Dose
Presenter: Carmen Valcarce, Ph.D., Chief
Scientific Officer, vTv Therapeutics
Key results presented included:
The treat-to-target (FPG: ~80-130mg/dL; post meal glucose:
<180-200 mg/dL) design of the study allowed changes in insulin
dose after the insulin-optimization period. To evaluate the effect
of these insulin adjustments on HbA1c, several pre-planned analyses
were performed grouping the participants according to their change
in total insulin doses (decreased, stable or increased).
- Patients randomized to TTP399 achieved better glycemic control
(improved HbA1c) while reducing insulin dose. In the
placebo-treated group, as expected, reduction in insulin dose was
on average associated with a worsening in HbA1c.
- TTP399 significantly reduced HbA1c compared to placebo (0.41%,
p=0.01) in patients that decreased their insulin dose or maintained
stable insulin dose throughout the study (0.35%, p=0.04).
- Significantly fewer patients in the TTP399 treated group
required increases to their insulin dose to maintain their glycemic
targets.
- In agreement with the overall analysis, trends towards
reduction in hypoglycemic and ketone events were observed in the
TTP399 treated group compared to placebo in the subgroups.
About the Simplici-T1 Study Simplici-T1 was a
multi-center, randomized, double-blind, adaptive study assessing
the safety and efficacy of TTP399 as an adjunct to insulin therapy
in adults with T1D. The primary endpoint was the change in HbA1c at
week 12. The study was conducted with support from JDRF, the
leading global organization funding research in type 1
diabetes.
This Phase 2 learn-and-confirm study was conducted in two parts
under a treat-to-target protocol to evaluate the safety and
efficacy of TTP399 in T1D patients over 12 weeks of daily dosing
following a multi-week insulin optimization and placebo run-in
period. Part 1 enrolled 19 patients on both insulin pumps and CGMs.
The positive topline results from the learning phase - Part 1 were
reported in June 2019. The confirming phase - Part 2, enrolled
85 patients that used either insulin pumps or multiple daily
injections of insulin; CGMs were allowed for those patients using
the devices for at least three months prior to the start of the
study. The positive topline results from Part 2 of the SimpliciT-1
Study were reported in February 2020.
About Type 1 Diabetes Type 1 diabetes (T1D) is
an autoimmune disease in which a person’s pancreas stops producing
insulin, a hormone that enables people to get energy from food. It
occurs when the body’s immune system attacks and destroys the
insulin-producing cells in the pancreas, called beta cells. While
its causes are not yet entirely understood, scientists believe that
both genetic factors and environmental triggers are involved. Its
onset has nothing to do with diet or lifestyle. There is nothing
you can do to prevent T1D, and—at present—nothing you can do to
cure it.
About vTv Therapeutics vTv Therapeutics
Inc. is a clinical-stage biopharmaceutical company focused on
developing oral small molecule drug candidates. vTv has a pipeline
of clinical drug candidates led by programs for the treatment of
type 1 diabetes, Alzheimer’s disease, and inflammatory disorders.
vTv’s development partners are pursuing additional indications in
type 2 diabetes, chronic obstructive pulmonary disease (COPD), and
genetic mitochondrial diseases.
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from any future results, performance or achievements expressed or
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could cause our results to vary from expectations include those
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these cautionary statements.
Nura StrongVP of Business
Developmentnstrong@vtvtherapeutics.com
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