02/07/2020 | Press release | Distributed by Public on 02/07/2020 15:13
HIGH POINT, N.C., Feb. 07, 2020 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced that it will release the topline results from Part 2 of the Phase 2 Simplici-T1 trial assessing TTP399 as an oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D) on Monday, February 10th at 7:00am ET. vTv Therapeutics' leadership team will then host an investor conference call that day at 8:30am ET.
In June 2019, the company announced positive results from Part 1 of the Phase 2 study that showed a statistically significant reduction in HbA1c without increases in ketoacidosis or hypoglycemia. In Part 1, TTP399 was well tolerated with similar incidences of treatment-emergent adverse events overall and by system organ class. Part 1 had no serious adverse event reported, and no report of diabetic ketoacidosis or severe hypoglycemia.
|Investor Call and Webcast Dial-In Information|
The 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.
Simplici-T1 is 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 the same 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 Phase 2 - Part 1 were reported in June, 2019. Part 2 enrolled 85 patients that used either insulin pumps or multiple daily injections of insulin, with CGMs not required.
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage pharmaceutical company focused on treating metabolic diseases to minimize their long-term complications through end-organ protection. vTv has an innovative pipeline of first-in-class small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of metabolic diseases and their long term complications such as type 1 diabetes and Alzheimer's disease. 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.
JDRF is the leading global organization funding T1D research. Its mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since its inception. JDRF is an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. It collaborates with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. JDRF's staff and volunteers throughout the United States and its six international affiliates are dedicated to advocacy, community engagement and a vision of a world without T1D. For more information, please visit jdrf.org or on Twitter: @JDRF.
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.
Lazar FINN Partners
Source: vTv Therapeutics Inc.