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vTv to Host Key Opinion Leader Event to Discuss the Type 1 Diabetes Treatment Landscape and Emerging Therapies as Adjuncts to Insulin
The event will highlight the current treatment landscape in T1D and unmet need for additional therapies, with a focus on treatment adjuncts to insulin. vTv Therapeutics will also provide a brief overview and update on the company's ongoing Phase 2 clinical trial, the Simplici-T1 study, evaluating TTP399, a liver-selective Glucokinase Activator, as an add-on to insulin therapy for patients with T1D.
A live webcast of the event will be available here and can also be found on the Investor page of vTv’s website at www.vtvtherapeutics.com. The archived version of the webcast will be available for replay on the Webcasts section of the Investors page of vTv Therapeutics’ website for 90 days following the event.
John B. Buse, MD, PhD
Verne S. Caviness Distinguished Professor
Division of Endocrinology
Director, Diabetes Center
NC Translational and Clinical Sciences Institute
Executive Associate Dean, Clinical Research
University of North Carolina School of Medicine Kevan C. Herold, MD
Professor of Immunobiology and Internal Medicine
Deputy Director, Yale Center for Clinical Investigation
- Esther Latres, PhD
Director, Research, JDRF
About the Simplici-T1 Study:
Simplici-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 19 patients on both insulin pumps and continuous glucose monitors (CGMs). The topline results from Phase 2 - Part 1 were reported in
- The study met its primary endpoint of change in A1c from baseline after 12 weeks of treatment. Patients treated with TTP399 (n=8) showed a statistically significant mean reduction in HbA1c of 0.7% (p=0.03) at 12 weeks relative to the placebo group (n=11).
- TTP399 was well tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class. The study had neither a serious adverse event nor an incident of diabetic ketoacidosis reported.
Part 2 is now fully-enrolled with patients utilizing a treatment regimen that includes either insulin pumps or multiple daily injection therapy, with CGMs optional. Topline results from the study are expected in the first quarter of 2020.
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
Source: vTv Therapeutics Inc.