vTv Therapeutics to Present Full Clinical Study Results from the Positive Phase 2 Simplici-T1 Study of TTP399, Potential First-in-Class Oral Adjunctive Therapy for Patients with Type 1 Diabetes at the American Diabetes Association’s 80th Virtual Scientific

Rhea-AI Summary

vTv Therapeutics (Nasdaq: VTVT) has announced that two late-breaking abstracts showcasing TTP399 as an oral adjunctive therapy for type 1 diabetes will be virtually presented at the American Diabetes Association’s 80th Scientific Sessions from June 12–16, 2020. The Phase 2 (Part 2) Simplici-T1 trial showed TTP399's positive impact on lowering HbA1c, reducing insulin dosage, and increasing Time in Range in T1D patients. The trial's presentations on June 13 will provide further data supporting these findings.

Positive

• Positive topline results from Phase 2 Simplici-T1 trial demonstrating TTP399's efficacy in lowering HbA1c, reducing insulin intake, and increasing Time in Range in T1D patients.
• Two late-breaking abstracts will be presented at the prestigious American Diabetes Association’s Scientific Sessions, potentially increasing visibility and interest in TTP399.

Negative

• None.

HIGH POINT, N.C., May 27, 2020 (GLOBE NEWSWIRE) -- 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 Strong
VP of Business Development
nstrong@vtvtherapeutics.com 

FAQ

What is the purpose of the Simplici-T1 trial for TTP399?

The Simplici-T1 trial aims to evaluate the safety and efficacy of TTP399 as an adjunct to insulin therapy in adults with type 1 diabetes.

When will the results of the Simplici-T1 trial be presented?

Results from the Simplici-T1 trial will be presented virtually on June 13, 2020, at the American Diabetes Association’s 80th Scientific Sessions.

What were the initial results of the Phase 2 Simplici-T1 trial?

The initial results showed positive outcomes, including a reduction in HbA1c levels and decreased insulin requirements among participants.

How does TTP399 improve treatment for type 1 diabetes?

TTP399 is designed to enhance glycemic control, allowing patients to achieve better blood sugar levels with potentially lower insulin doses.

What are the implications of the TTP399 trial results for the stock VTVT?

Positive trial results and subsequent presentations could enhance investor confidence and lead to increased stock interest for vTv Therapeutics (VTVT).