vTv Therapeutics to Present Full Clinical Study Results from the Positive Phase 2 Simplici-T1 Study of TTP399, Potential Firs...
May 27 2020 - 7:30AM
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced that two
late-breaking abstracts reinforcing the potential of TTP399 as an
oral adjunctive therapy in type 1 diabetes will be presented
virtually at the American Diabetes Association’s 80th Scientific
Sessions, which is being held virtually, June 12–16, 2020.
In February 2020 the Company announced positive topline results
from its Phase 2 (Part 2) Simplici-T1 trial showing that TTP399
lowered HbA1c, decreased insulin dose, and increased Time in Range
in patients with type 1 diabetes (T1D).
Details of the virtual presentations which will provide full
clinical study data from that trial follow:
Late-Breaking Poster Title: “The Simplici-T1
Trial: Glucokinase Activator TTP399 Improves Glycemic Control in
Patients with Type 1 Diabetes” Poster
Number: 122-LB Category: 12-F
Clinical Therapeutics/New Technology—Other Therapeutic Agents.
Date and Time: Saturday, June 13,
2020, 10:00 AM CT (11:00 AM ET)
Late-Breaking Poster Title: “The Simplici-T1
Trial: Relationship between Glycemic Control and Insulin Dose”
Poster Number: 123-LB
Category: 12-F Clinical Therapeutics/New
Technology—Other Therapeutic Agents. Date and
Time: Saturday, June 13, 2020, 10:00 AM CT (11:00 AM
ET) 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.
About Type 1 Diabetes 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. 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. For more information, please visit
www.vtvtherapeutics.com or follow us on Twitter:
@vTvTherapeutics.
Forward-Looking Statements This release
contains forward-looking statements, which involve risks and
uncertainties. These forward-looking statements can be identified
by the use of forward-looking terminology, including the terms
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and, in each case, their negative or
other various or comparable terminology. All statements other than
statements of historical facts contained in this release, including
statements regarding the timing of our clinical trials, our
strategy, future operations, future financial position, future
revenue, projected costs, prospects, plans, objectives of
management and expected market growth are forward-looking
statements. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Important factors that
could cause our results to vary from expectations include those
described under the heading “Risk Factors” in our Annual Report on
Form 10-K and our other filings with the SEC. These
forward-looking statements reflect our views with respect to future
events as of the date of this release and are based on assumptions
and subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking
statements. These forward-looking statements represent our
estimates and assumptions only as of the date of this release and,
except as required by law, we undertake no obligation to update or
review publicly any forward-looking statements, whether as a result
of new information, future events or otherwise after the date of
this release. We anticipate that subsequent events and developments
will cause our views to change. Our forward-looking statements do
not reflect the potential impact of any future acquisitions,
merger, dispositions, joint ventures or investments we may
undertake. We qualify all of our forward-looking statements by
these cautionary statements.
Nura StrongVP of Business
Developmentnstrong@vtvtherapeutics.com
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