Tourmaline Bio Highlights Cardiovascular Inflammation Focus and Announces Key Clinical and Strategic Updates at Investor Day
Tourmaline Bio Highlights Cardiovascular Inflammation Focus and Announces Key Clinical and Strategic Updates at Investor Day
– Phase 2 TRANQUILITY trial surpasses enrollment target, with 143 total patients enrolled; topline data expected in second quarter of 2025 –
– 第二階段TRanquility試驗超過了招募目標,共招募了143名患者;預計在2025年第二季度發佈初步數據 –
– Deepak L. Bhatt, MD, MPH, MBA and Dipender Gill, MD, PhD join Cardiovascular Scientific Advisory Board –
– Deepak L. Bhatt博士、公共衛生碩士、工商管理碩士和Dipender Gill博士、哲學博士加入心血管科學顧問委員會 –
– Company nominates abdominal aortic aneurysm as second cardiovascular indication for pacibekitug, expanding development for inflammation-driven cardiovascular disease –
– 公司提名腹主動脈瘤作爲pacibekitug的第二個心血管適應症,擴展針對炎症驅動的心血管疾病的發展 –
NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today is hosting its Investor Day, beginning at 10 a.m. ET, during which it will outline progress across its pipeline and provide updates on its strategic priorities.
紐約,2024年12月10日(全球新聞稿) -- Tourmaline Bio, Inc.(Tourmaline)(納斯達克:TRML),是一家處於晚期階段的臨床生物技術公司,致力於開發變革性藥物,以顯著改善面臨改變生活的免疫和炎症疾病患者的生活,今天正在舉辦其投資者日活動,活動從東部時間上午10點開始,期間將概述其管道的進展,並提供其戰略優先事項的更新。
"We continue to be laser-focused on our development efforts for pacibekitug in order to maximize the potential of this program," said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline Bio. "Today's updates, including the over-enrollment of our TRANQUILITY trial, the expansion of our Cardiovascular Scientific Advisory Board, and the addition of a new indication, reflect the strength of our science, the caliber of our team, and our commitment to redefining standards of care for patients worldwide."
「我們繼續專注於pacibekitug的開發工作,以最大化該項目的潛力,」 Tourmaline Bio的聯合創始人兼首席執行官Sandeep Kulkarni博士說。「今天的更新,包括我們TRANQUILITY試驗的超額入組、心血管科學顧問委員會的擴展以及新適應症的增加,反映了我們的科學實力、團隊的素質以及我們重新定義全球患者護理標準的承諾。」
Phase 2 TRANQUILITY Trial Progress
Tourmaline today is announcing the over-enrollment of its Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease. A total of 143 patients have been enrolled in the Phase 2 TRANQUILITY trial, as compared to 120 patients originally anticipated. Tourmaline expects to report topline data from this trial in the second quarter of 2025.
第2階段TRANQUILITY試驗進展
Tourmaline今天宣佈其第2階段TRANQUILITY試驗的超額入組,該試驗評估pacibekitug在高敏感性C反應蛋白升高和慢性腎病患者中的每季度和每月皮下給藥。第2階段TRANQUILITY試驗已入組142名患者,而最初預計爲120名患者。Tourmaline預計將於2025年第二季度報告該試驗的頂線數據。
The TRANQUILITY trial is the starting point of Tourmaline's clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. If successful, results from the TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready for ASCVD.
TRANQUILITY試驗是Tourmaline針對pacibekitug的臨床開發計劃的起點,旨在潛在治療動脈粥樣硬化性心血管病(ASCVD)和其他心血管疾病。如果成功,TRANQUILITY試驗的結果預計將使Tourmaline爲ASCVD的第3階段做好準備。
Expansion of Cardiovascular Scientific Advisory Board (CV SAB)
Tourmaline has expanded its CV SAB with two new appointments:
心血管科學顧問委員會(CV SAB)的擴展
Tourmaline擴展了其CV SAb,新增了兩位成員:
- Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI joins as Chair of the Tourmaline CV SAB. Dr. Bhatt is the Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Bhatt has served as principal investigator for a number of groundbreaking cardiovascular clinical trials, bringing to the CV SAB decades of clinical trial expertise.
- Dipender Gill, MD, PhD is the CEO of Sequoia Genetics and a specialist in leveraging human genetic evidence for drug development. Dr. Gill adds deep translational insight to Tourmaline's strategic focus.
- Deepak L. Bhatt,醫學博士,公共衛生碩士,工商管理碩士,FACC,FAHA,FESC,MSCAI擔任Tourmaline CV SAb的主席。Bhatt博士是紐約市西奈山醫院Fuster心臟醫院的主任,同時也是西奈山伊坎醫學院心血管醫學的弗拉基米爾·福斯特教授。Bhatt博士曾擔任多項開創性心血管臨床試驗的首席研究員,爲CV SAb帶來了數十年的臨床試驗經驗。
- Dipender Gill,醫學博士,哲學博士是Sequoia Genetics的首席執行官,專注於利用人類遺傳證據進行藥物開發。Gill博士爲Tourmaline的戰略重點提供了深刻的轉化見解。
Indication Expansion in Cardiovascular Inflammation
Tourmaline has nominated abdominal aortic aneurysm (AAA) as an additional indication within its cardiovascular inflammation disease focus for pacibekitug. Tourmaline expects to provide additional details on a planned Phase 2 proof-of-concept trial in AAA after topline results from the Phase 2 TRANQUILITY trial are reported in Q2 2025.
心血管炎症的指徵擴展
Tourmaline已經提名腹主動脈瘤(AAA)作爲其心血管炎症疾病焦點中pacibekitug的額外指徵。Tourmaline預計將在2025年第二季度報告TRANQUILITY試驗的頂線結果後提供關於AAA計劃的二維概念驗證試驗的更多細節。
Update on Thyroid Eye Disease (TED) Development Program
In light of Tourmaline's focus on cardiovascular inflammation, initiation of a Phase 3 trial in TED will be dependent upon results from the ongoing Phase 2b spiriTED trial. Topline data from the Phase 2b spiriTED trial are expected in the second half of 2025; Tourmaline expects to provide additional information on its future development plans in TED at that time.
關於甲狀腺眼病(TED)開發計劃的更新
鑑於Tourmaline關注心血管炎症,TED的第三階段試驗啓動將取決於正在進行的20億spiriTED試驗的結果。預計20億spiriTED試驗的頂層數據將在2025年下半年公佈;Tourmaline預計將在那時提供有關其未來TED開發計劃的更多信息。
Investor Day Event Information
Tourmaline's Investor Day will take place on December 10, 2024, beginning at 10 a.m. ET. To register for Tourmaline's Investor Day, please click here or visit the Events and Presentations section of Tourmaline's website. A replay of the webcast will be available on Tourmaline's website following the event. It is recommended that participants register at least 15 minutes in advance of the event.
投資者日活動信息
Tourmaline的投資者日將於2024年12月10日上午10點(東部時間)舉行。要註冊Tourmaline的投資者日,請點擊這裏或訪問Tourmaline官網的活動和演示部分。活動結束後,Tourmaline的官網將提供網絡直播的重播。建議參與者至少提前15分鐘註冊。
About Tourmaline Bio
Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline's lead asset is pacibekitug (also referred to as TOUR006). For more information about Tourmaline Bio and pacibekitug, please visit or follow us on LinkedIn or X.
關於Tourmaline Bio
Tourmaline是一家處於後期臨床階段的生物技術公司,致力於開發能夠顯著改善患有重大免疫和炎症疾病患者生活的變革性藥物。Tourmaline的主要資產是pacibekitug(也稱爲TOUR006)。有關Tourmaline Bio和pacibekitug的更多信息,請訪問或在LinkedIn或X上關注我們。
About Pacibekitug
Pacibekitug (also referred to as TOUR006) is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future.
關於Pacibekitug
Pacibekitug(也稱爲TOUR006)是一種長效、全人源、抗IL-6單克隆抗體,具有一流的潛力和差異化的特性,包括天然的長半衰期、低免疫原性和對IL-6的高結合親和力。Pacibekitug之前已在大約450名參與者中研究過,包括自體免疫疾病患者,涉及六個已完成的臨床試驗。Tourmaline目前正在開發Pacibekitug用於動脈粥樣硬化心血管疾病(ASCVD)和甲狀腺眼病(TED)作爲其前兩個適應症,計劃未來擴展到腹主動脈瘤(AAA)和其他疾病。
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "believe," "designed to," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on Tourmaline's current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug; the timing of initiation, progress and results of Tourmaline's current and future clinical trials for pacibekitug, including reporting of data therefrom and additional details regarding the planning thereof; the timing of future announcements regarding Tourmaline's development plans and the content of such announcements; the timing of a planned Phase 2 proof-of-concept clinical trial and of Phase 3 clinical trial readiness; and the timing and potential to expand pacibekitug into additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline's current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline's current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline's current or future product candidates and/or current or future target indications; the risk that Tourmaline's current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline's estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline's business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") on November 7, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
關於前瞻性聲明的警示說明
本新聞稿中的任何聲明,若不描述歷史事實,可能構成前瞻性陳述,如1995年《私人證券訴訟改革法案》所定義。這些陳述可能通過"相信"、"旨在"、"期待"、"可能"、"計劃"、"潛在"、"將"及類似表達來識別,並基於Tourmaline目前的信念和期望。這些前瞻性陳述包括對Pacibekitug的開發及潛在治療效益的預期;Tourmaline當前和未來Pacibekitug臨床試驗的啓動、進展和結果的時間安排,包括數據的報告及相關計劃的更多細節;關於Tourmaline開發計劃的未來公告的時間及內容;計劃中的第二階段概念驗證臨床試驗和第三階段臨床試驗準備的時間;以及將Pacibekitug擴展到其他適應症的時間和潛力。這些陳述涉及風險和不確定性,可能導致實際結果與這些陳述所反映的結果存在重大差異。可能導致實際結果與這些陳述顯著不同的風險和不確定性,包括在治療產品候選者開發中固有的不確定性,如Tourmaline當前或未來的任何一個或多個產品候選者未能成功開發或商業化的風險;Tourmaline當前或未來產品候選者的任何計劃臨床試驗延誤或停止的風險;從臨床前試驗和臨床試驗中觀察到的安全性、活性或效果持久性的信號等先前結果可能無法複製或在涉及Tourmaline當前或未來產品候選者和/或當前或未來目標適應症的進行中或未來的研究或臨床試驗中無法延續的風險;Tourmaline的當前或未來產品候選者或與其施用相關的程序未能達到Tourmaline期待的安全性或有效性標準的風險;關於Tourmaline的費用、資本需求和額外融資需求的估計準確性的風險;預期或現有競爭的變化;監管環境的變化;監管審批流程的不確定性和時間;意外的訴訟或其他爭議;宏觀經濟條件對Tourmaline的業務、臨床試驗和財務狀況的影響;以及Tourmaline的季度報告(表格10-Q)中描述的其他風險和不確定性,該報告於2024年11月7日提交給美國證券交易委員會("SEC"),以及Tourmaline不時提交給SEC的其他文件。任何前瞻性陳述僅在本新聞稿日期有效,並基於截至本文發佈之日Tourmaline所獲取的信息,Tourmaline不承擔也不打算更新任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。
Media Contact
Scient PR
Sarah Mishek
SMishek@ScientPR.com
媒體聯繫
Scient PR
Sarah Mishek
SMishek@ScientPR.com
Investor Contact
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
投資者聯繫
Meru Advisors
李·M·斯特恩
lstern@meruadvisors.com
譯文內容由第三人軟體翻譯。