TTP399, a novel glucokinase activator shows
statistically significant reduction in HbA1c without increases in
ketones or hypoglycemia
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced positive
results from the primary analysis of Part 1 of the Phase 2
Simplici-T1 trial assessing the liver-selective glucokinase
activator TTP399 in adult patients with type 1 diabetes (T1D).
In this double-blind, placebo-controlled 12-week trial, the
baseline mean HbA1c for the groups treated with TTP399 and placebo
was 7.3% and 7.4%, respectively. Patients treated with TTP399 (n=8)
showed a statistically significant mean reduction in HbA1c of 0.6%
at 12 weeks, while the group treated with placebo (n=11) showed a
mean increase in HbA1c of 0.1%, resulting in a mean difference of
0.7% in the TTP399 group relative to the placebo group (p=0.03). At
the same time, trends toward decreased insulin usage were observed
in the group treated with TTP399.
Patients in this study received insulin adjustments to optimize
glucose levels. As a result, the primary analysis included a
responder analysis in which a ‘treatment responder’ was defined as
a patient who had a decrease in HbA1c at Week 12, no abnormal
lactate or ketones detected in blood or urine during the study, and
no increased time in Level 2 hypoglycemia (blood glucose <54
mg/dl). Of all study patients, there was a greater proportion of
responders in the group treated with TTP399 (75%) than in the
placebo group (9%) (p=0.006). Consistent with the treatment
responder results, abnormal ketones were observed in plasma or
urine in 63% of patients on placebo vs. 13% of patients treated
with TTP399.
TTP399 was well tolerated with similar incidences of
treatment-emergent adverse events overall and by system organ
class. The study had no serious adverse event reported. The study
also had no report of diabetic ketoacidosis or severe
hypoglycemia.
“These results from a small group of patients with type 1
diabetes are very exciting. If they hold up in part 2 of the trial,
TTP399 will be the most impressive adjunctive therapy to insulin in
type 1 diabetes care,” said 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.
More detailed study results will be presented at the 55th Annual
Meeting of the European Association for the Study of Diabetes held
in Barcelona in September.
“While insulin remains the main line of treatment for T1D, we
believe that adjunctive treatments such as TTP399 can lead to
improvements in metabolic balance and favorable treatment outcomes
for people living with T1D,” said Esther Latres, Ph.D., JDRF
Director Research. “We are encouraged by the initial results and
look forward to critical additional evidence to ascertain the
benefits of this therapy and laud the efforts of vTv Therapeutics
for their innovative approach to address unmet clinical needs.”
“We are excited that TTP399 has demonstrated clinically
meaningful efficacy as an adjunct therapy for T1D in this group of
patients, and are pleased to have seen a favorable safety profile
consistent with what we have seen in our previous trials in
patients with type 2 diabetes,” said Steve Holcombe, President and
CEO of vTv Therapeutics. “Given the well-controlled patient
population in this part of the trial, we look forward to the
results from part 2 in a broader patient population expected in Q1
2020.”
About TTP399The glucokinase enzyme (GK) is a key
regulator of glucose metabolism, and its activation has been shown
to increase glucose utilization, which in turn lowers blood
glucose. TTP399 is an orally available GK activator that is
designed for superior glucose control by targeting GK activation
only in the liver with an insulin-independent mechanism of
action.
TTP399 has been studied in 12 clinical trials to date, including
a 6-month Phase 2b trial in patients with type 2 diabetes where it
demonstrated sustained, meaningful reductions in HbA1c and was
well-tolerated, with negligible incidences of hypoglycemia and
hyperlipidemia, and no occurrences of diabetic ketoacidosis.
About Simplici-T1Simplici-T1 is a multi-center,
randomized, double-blind, adaptive study assessing the
pharmacokinetics, pharmacodynamics, safety and tolerability of
TTP399 as an adjunct to insulin therapy in adult patients with T1D.
The study is being conducted with support from JDRF, the leading
global organization funding research in type 1 diabetes.
The Phase 2 learn and confirm study is being conducted in two
parts to evaluate the safety and efficacy of TTP399 in T1D patients
over twelve weeks of daily dosing. Part 1 enrolled 20 patients on
both insulin pumps and CGM’s. Part 2 is currently enrolling up to
approximately 90 patients using either insulin pumps or multiple
daily injection therapy, with CGMs optional. Enrollment of patients
in Part 2 of the study commenced in May 2019 and top line results
from the study are expected in the first quarter of 2020.
About Type 1 DiabetesType 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 TherapeuticsvTv Therapeutics Inc. is a
clinical-stage biopharmaceutical company engaged in the discovery
and development of orally administered small molecule drug
candidates to fill significant unmet medical needs. vTv has a
pipeline of clinical drug candidates led by programs for the
treatment of diabetes, Alzheimer’s disease, and inflammatory
disorders.
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