Cadisegliatinisapotentialfirst-in-classoralliverselectiveglucokinaseactivatorforT1D,whichhasbeen granted Breakthrough Therapy designation by the FDA for T1D

Cadiseglatinisapotentialfirst-in-classoralliverselectiveglucokinaseactivatorforT1D，已被FDA授予T1D突破性治疗指定

Cadisegliatinhasbeendosedinover500subjectstodate,including300patientswith diabetes

迄今为止，500多名受试者服用了Cadisegliatin，其中包括300名糖尿病患者

HIGH POINT, N.C., June 24, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the first patient has been screened in the Company’s CATT1 pivotal trial evaluating cadisegliatin as an adjunct treatment of type 1 diabetes (T1D).

HIGH POINT，N.C.，2024年6月24日（Global NEWSWIRE）--vTv Therapeutics Inc.（纳斯达克：VTVTVT），一家拥有创新的小分子临床组合和糖尿病领先项目的晚期生物制药公司，今天宣布，该公司的CATT1关键试验筛选了第一名患者，该试验评估了卡地格列汀作为1型糖尿病（T1D）的辅助治疗。

CATT1 is designed to be a registrational study and is one of several trials that will form the core of the regulatory submission for cadisegliatin, a potential first-in-class, oral, liver selective, glucokinase activator for T1D that has been dosed in over 500 subjects to date, including 300 patients with T1D and type 2 diabetes (T2D)..

CATT1被设计为一项注册研究，是几项试验之一，这些试验将构成卡地格列汀监管提交的核心，卡地格列汀是一种潜在的T1D一流口服肝选择性葡萄糖激酶激活剂，迄今已在500多名受试者中使用，其中包括300名T1D和2型糖尿病（T2D）患者。。

“Maintaining glycemic control remains a high and burdensome unmet need for the nearly 8 million people with T1D worldwide. Cadisegliatin is a new approach to current standards of care that is designed to regulate blood glucose levels by selectively activating glucose pathways in the liver,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics.

vTv Therapeutics董事长、总裁兼首席执行官保罗·塞赫里（PaulSekhri）表示：“对于全球近800万T1D患者来说，维持血糖控制仍然是一项艰巨而繁重的未满足需求。卡地格列汀是目前护理标准的一种新方法，旨在通过选择性激活肝脏中的葡萄糖途径来调节血糖水平。”。

“Screening the first patient marks an important milestone for our late stage cadisegliatin program and brings us closer to our mission of delivering novel treatments that help improve the lives of millions of patients living with diabetes.”.

“筛查第一名患者标志着我们晚期cadiseglatin计划的一个重要里程碑，使我们更接近提供新疗法的使命，帮助改善数百万糖尿病患者的生活。”。

Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics added, “85% of patients with T1D experience one or two hypoglycemic episodes every week, representing an important barrier that limits optimal treatment. Cadisegliatin is designed to reactivate the glucose-regulating capacity in the liver independent of insulin to safely improve episodes of hyper- and hypoglycemia in patients with diabetes.”.

vTv Therapeutics首席医疗官Thomas Strack博士补充道：“85%的T1D患者每周会出现一次或两次低血糖发作，这是限制最佳治疗的一个重要障碍。cadiseglatin旨在重新激活肝脏的葡萄糖调节能力，而不依赖于胰岛素，以安全地改善糖尿病患者的高血糖和低血糖发作。”。

CATT1 is a randomized, double-blind, placebo-controlled pivotal study evaluating the efficacy and safety of cadisegliatin over 12 months in adults 18 years or older diagnosed with T1D. The trial is expected to enroll approximately 150 patients at up to 20 sites in the U.S. Two doses of orally administered cadisegliatin versus placebo will be assessed in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion who use a continuous glucose monitor.

CATT1是一项随机，双盲，安慰剂对照的关键性研究，评估了18岁或以上被诊断为T1D的成年人在12个月内卡地格列汀的疗效和安全性。该试验预计将在美国多达20个地点招募约150名患者。目前正在接受多次每日胰岛素注射和连续皮下胰岛素输注治疗的患者将评估两剂口服卡地格列汀与安慰剂的疗效，这些患者使用连续血糖监测仪。

The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group..

该研究的主要疗效终点将比较卡地格列汀治疗组和安慰剂组之间2级或3级低血糖事件的发生率。。

Cadisegliatin will also be evaluated as an adjunctive therapy to insulin in patients with T2D as part of a planned Phase 2 trial in Middle Eastern countries in collaboration with G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, a UAE-based health technology group which is expected to start in the second half of 2024..

作为计划在中东国家与G42 Healthcare Research Technology Projects LLC及其临床研究组织IROS（一家总部位于阿联酋的健康技术集团，预计将于2024年下半年开始）合作进行的第二阶段试验的一部分，卡地格列汀还将被评估为T2D患者胰岛素的辅助治疗。。

AboutCadisegliatin

关于Cadisegliatin

Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator with first-in-class potential as an adjunct treatment for type 1 diabetes (T1D). Selectively acting on the liver, cadisegliatin increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage..

cadiseglatin（TTP399）是一种新型口服小分子肝选择性葡萄糖激酶激活剂，具有一流的潜力，可作为1型糖尿病（T1D）的辅助治疗。选择性地作用于肝脏，cadiseglatin独立于胰岛素增加葡萄糖激酶的活性，通过肝脏葡萄糖摄取和糖原储存来改善血糖控制。。

AboutvTvTherapeutics

关于TV治疗学

vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv’s clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications including type 2 diabetes and other chronic conditions..

vTv Therapeutics Inc.是一家晚期生物制药公司，专注于开发口服小分子候选药物。vTv的临床管道由cadiseglatin领导，cadiseglatin是胰岛素治疗1型糖尿病的潜在辅助疗法。vTv及其开发合作伙伴正在寻求其他适应症，包括2型糖尿病和其他慢性病。。

Forward-LookingStatement

前瞻性陈述

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.

本版本包含前瞻性声明，涉及风险和不确定性。这些前瞻性陈述可以通过使用前瞻性术语来识别，包括术语“预期”，“相信”，“可能”，“估计”，“预期”，“打算”，“可能”，“计划”，“潜在”，“预测”，“项目”，“应该”，“目标”，“将会”，“将会”，以及在每种情况下，它们的负面或其他各种或类似术语。

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.

本新闻稿中包含的除历史事实声明之外的所有声明，包括关于我们临床试验时间、我们的战略、未来运营、未来财务状况、未来收入、预计成本、前景、计划、管理目标和预期市场增长的声明，都是前瞻性声明。

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.

这些声明涉及已知和未知的风险、不确定性和其他重要因素，这些因素可能导致我们的实际结果、业绩或成就与前瞻性声明中明示或暗示的任何未来结果、业绩或成就存在重大差异。可能导致我们的结果与预期不符的重要因素包括我们在10-K表年度报告中“风险因素”标题下描述的因素以及我们向SEC提交的其他文件。

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.

这些前瞻性声明反映了我们对截至本发布之日的未来事件的看法，并基于假设，并存在风险和不确定性。鉴于这些不确定性，您不应过度依赖这些前瞻性声明。这些前瞻性声明仅代表我们截至本发布日期的估计和假设，除法律要求外，我们没有义务公开更新或审查任何前瞻性声明，无论是否因此。

Contact

联系人

Ashley Robinson

艾斯利·罗宾逊

LifeSci Advisors, LLC

LifeSci Advisors有限责任公司

arr@lifesciadvisors.com

arr@lifesciadvisors.com