VTv Therapeutics Announces Screening of First Patient in CATT1 Pivotal Trial Evaluating Cadisegliatin for Type 1 Diabetes
VTv Therapeutics Announces Screening of First Patient in CATT1 Pivotal Trial Evaluating Cadisegliatin for Type 1 Diabetes
Cadisegliatin is a potential first-in-class oral liver selective glucokinase activator for T1D, which has been granted Breakthrough Therapy designation by the FDA for T1D
Cadisegliatin 是 一個 潛力 同類首創 口頭的 肝 選擇性的 葡萄糖激酶 活化劑 爲了 T1D, 其中 有 被美國食品藥品管理局授予 T1D 突破性療法稱號
Cadisegliatin has been dosed in over 500 subjects to date, including 300 patients with diabetes
Cadisegliatin 有 是 劑量 在 結束了 500 主題 到 日期, 包括 300 病人 和 糖尿病
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). 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).
北卡羅來納州海波因特,2024年6月24日(GLOBE NEWSWIRE)——vTV Therapeutics Inc.(納斯達克股票代碼:VTVT)是一家後期生物製藥公司,擁有創新的小分子臨床產品組合和糖尿病領域的主導項目,今天宣佈,該公司已對第一位患者進行了篩查 CATT1 關鍵試驗 評估 cadesgliatin 作爲 1 型糖尿病 (T1D) 的輔助治療。CATT1 被設計爲一項註冊研究,是幾項試驗之一,這些試驗將構成監管申報的核心 cadisegliatin, 一種潛在的同類首創口服、肝臟選擇性葡萄糖激酶激活劑,迄今已在500多名受試者中服用,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. "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."
“對於全球近800萬T1D患者來說,維持血糖控制仍然是一項高而繁瑣的未得到滿足的需求。 Cadisegliatin 是實現當前護理標準的一種新方法,旨在通過選擇性激活肝臟中的葡萄糖通路來調節血糖水平。” vTV Therapeutics董事長、總裁兼首席執行官保羅·塞克裏說。“篩查第一位患者標誌着我們晚期的重要里程碑 cadisegliatin 計劃,使我們更接近我們的使命,即提供新療法,幫助改善數百萬糖尿病患者的生活。”
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首席醫學官托馬斯·斯特拉克博士補充說:“85%的T1D患者每週經歷一兩次降糖發作,這是限制最佳治療的重要障礙。 Cadisegliatin 旨在重新激活肝臟中獨立於胰島素的血糖調節能力,從而安全地改善糖尿病患者的高血糖和低血糖發作。”
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. 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.
CATT1 是一項隨機、雙盲、安慰劑對照的關鍵研究,旨在評估其療效和安全性 cadisegliatin 18 歲或以上被診斷患有 T1D 的成年人需超過 12 個月。該試驗預計將在美國多達20個地點招收約150名患者。兩劑口服給藥 cadisegliatin 對於目前正在接受每日多次胰島素注射和持續皮下胰島素輸注、使用連續血糖監測儀的患者,將對比安慰劑進行評估。該研究的主要療效終點將比較兩者之間2級或3級降糖事件的發生率 cadesgliatin-接受治療的受試者和安慰劑組的受試者。
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.
Cadisegliatin 作爲計劃與G42 Healthcare Research Technology Projects LLC及其臨床研究組織IROS合作在中東國家進行的2期試驗的一部分,還將作爲T2D患者胰島素的輔助療法進行評估,該試驗預計將於2024年下半年啓動。
About 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.
關於卡地塞格列汀
Cadisegliatin (TTP399) 是一種新型的口服小分子肝臟選擇性葡萄糖激酶激活劑,具有作爲1型糖尿病(T1D)輔助治療的首創潛力。選擇性地作用於肝臟, cadisegliatin 獨立於胰島素增加葡萄糖激酶的活性,通過肝葡萄糖攝取和糖原儲存改善血糖控制。
About vTv Therapeutics
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.
關於 vTV 治療學
vTV Therapeutics Inc. 是一家處於後期階段的生物製藥公司,專注於開發口服小分子候選藥物。vTV 的臨床產品線由 cadesgliatin,一種潛在的胰島素輔助療法,用於治療1型糖尿病。vTV及其開發合作伙伴正在研究其他適應症,包括2型糖尿病和其他慢性病。
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Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com
聯繫我們
阿什利·羅
LifeSci 顧問有限公司
arr@lifesciadvisors.com
Source: vTv Therapeutics Inc.
資料來源:vTV Therapeutics Inc.