Press Release

JDRF and vTv Therapeutics Announce Collaboration on Phase 2 Study of Novel Treatment for Type 1 Diabetes

vTv Therapeutics and JDRF enter into a $6 million industry partnership to explore the effect of liver-selective glucokinase activator TTP399 as an insulin-adjunctive therapy in type 1 diabetes

HIGH POINT, N.C.--(BUSINESS WIRE)--Sep. 6, 2017-- vTv Therapeutics Inc. (Nasdaq: VTVT) announced today that JDRF, the leading global organization funding type 1 diabetes (T1D) research, will provide funding to support a Phase 2 Proof of Concept study to explore the effect of vTv Therapeutics’ liver-selective glucokinase (GK) activator TTP399 as an oral drug for the treatment of T1D. The study is designed to evaluate whether TTP399 is well tolerated when administered as an add-on to insulin therapy for people with T1D and can significantly improve daily glucose profiles and HbA1c. JDRF has committed $3 million to the study, and vTv will contribute an equal amount.

“At JDRF, we are committed to funding promising research with the potential to cure, prevent and effectively treat type 1 diabetes,” said Esther Latres, director of research. “As we work toward a cure, it’s crucial that we’re also championing progress that will improve health outcomes and quality of life for people living with T1D. TTP399’s novel mechanism of action, combined with its oral administration, make it an ideal candidate for JDRF’s Glucose Control Research Program. We are excited to collaborate with the vTv Therapeutics team to bring this new treatment to those living with the disease.”

“We are thrilled to partner with JDRF to explore TTP399 as a new potential therapy for people with this life-threatening disease,” said Carmen Valcarce, Ph.D., executive vice president, chief scientific officer, vTv Therapeutics. “Based on the data we have gathered thus far in our Phase 2 studies in type 2 diabetes, we are optimistic that treatment with TTP399 will be well tolerated and potentially offer an improved and simplified therapy for people with type 1 diabetes.”

TTP399 is an orally available GK activator that is designed to target GK activation only in the liver for superior glucose control. In the liver, GK is a key regulator of glucose metabolism, and its activation has been shown to increase glucose utilization, which in turn lowers blood glucose. In a six-month Phase 2b clinical trial of TTP399 in patients with type 2 diabetes, TTP399 demonstrated a statistically significant reduction in HbA1c levels in all TTP399 dose groups compared with placebo. TTP399 was also found to be well-tolerated without increased incidences of hypoglycemia and hyperlipidemia compared to placebo.

About Type 1 Diabetes

Type 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 get rid of it.

About vTv Therapeutics Inc.

vTv 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 Alzheimer’s disease and diabetes as well as treatment of inflammatory disorders and the prevention of muscle weakness. Last year, vTv announced positive topline results from a placebo and active-comparator-controlled Phase 2b clinical study of TTP399, a liver-selective glucokinase activator under development for the treatment of type 2 diabetes.

The Company’s drug candidates were discovered with its high-throughput drug discovery platform, TTP Translational Technology®, which translates the functional modulation of human proteins into safe and effective medicines. For further company information, visit www.vtvtherapeutics.com.

About JDRF

JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our 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 billion in research funding since our inception. We are 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. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

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.

Source: vTv Therapeutics Inc.

vTv Therapeutics Inc.
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