Arch Biopartners' Cilastatin Drug Candidate to Participate in the PONTIAC Phase II Trial Targeting Acute Kidney Injury Caused by Drug Toxins
Arch Biopartners' Cilastatin Drug Candidate to Participate in the PONTIAC Phase II Trial Targeting Acute Kidney Injury Caused by Drug Toxins
- Arch is repurposing cilastatin, a dipeptidase-1 inhibitor, as a new treatment for acute kidney injury (AKI)
- Cilastatin is particularly well suited to prevent AKI caused by drug toxins due to its unique off-target effects that block toxin uptake into the kidney tissue
- Arch continues to perform a Phase II trial for LSALT peptide targeting cardiac surgery-associated-AKI
- Drug toxins and CS-AKI account for up to 50% of all AKI occurring in hospitals, for which there is no treatment available
- Arch將二肽酶-1抑制劑西司他丁作爲急性腎損傷（AKI）的新療法
- 西司他丁特別適合預防由藥物毒素引起的AKI，原因是由於其獨特的非靶向效應，它可以阻止毒素進入腎組織
- Arch繼續爲針對心臟手術相關AKI的LSALt肽開展II期試驗
- 藥物毒素和CS-AKI導致醫院內50%的所有AKI病例，目前沒有可用的治療方法
TORONTO, Aug. 02, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., ("Arch" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), announced today that cilastatin, the Company's second drug candidate for preventing acute kidney injury (AKI), will participate in the upcoming investigator led trial entitled "Prevention Of NephroToxin Induced Acute kidney injury with Cilastatin" (PONTIAC). PONTIAC is a 900 patient Phase II trial that will evaluate the efficacy of the dipeptidase-1 inhibitor cilastatin for preventing AKI caused by drugs such as antibiotics, chemotherapeutic agents and radiographic contrast.
2024年8月2日，多倫多（GLOBE NEWSWIRE） - Arch Biopartners Inc.（“Arch”或“公司”）（TSX Venture：ARCH和OTCQB：ACHFF）宣佈，該公司的第二個防止急性腎損傷（AKI）藥物候選cilastatin將參加即將到來的由“ Cilastatin預防NephroToxin誘導的急性腎損傷”的主持者進行的調查者領導的試驗（PONTIAC）。PONTIAC是一項900名患者的2期試驗，旨在評估dipeptidase-1抑制劑cilastatin用於預防由抗生素，化療藥劑和放射性造影劑等藥物引起的AKI的療效。
The PONTIAC clinical team of investigators, based out of the Universities of Calgary and Alberta, was awarded $1,500,000 by the Canadian Institutes of Health Research (CIHR) to fund the trial. The clinical team also received $400,000 as part of the Accelerating Clinical Trials (ACT) call for proposals to "Evaluate Canadian Biotechnologies with Randomized Controlled Trials" (October 2023). Funds from both grants will be used by the clinical team to conduct the PONTIAC trial.
位於卡爾加里和阿爾伯塔大學的PONTIAC臨床研究小組獲得了150萬加元的加拿大衛生研究所（CIHR）撥款資助該試驗。該臨床小組還獲得了40萬美元加速臨床試驗（ACT）的提案贈款，以“隨機對照試驗評估加拿大生物技術”（2023年10月）。兩項撥款的資金將由臨床小組用於進行PONTIAC試驗。
The PONTIAC clinical team sponsoring the trial is based in Calgary and is currently preparing to submit a Clinical Trial Application (CTA) to Health Canada to proceed with the trial by the fourth quarter of 2024. Arch is acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice.
主持試驗的PONTIAC臨床小組位於卡爾加里，並正在準備在2024年第四季度向加拿大衛生部提交臨床試驗申請（CTA）以繼續試驗。Arch作爲撥款機會的研究合作伙伴，提供西司他丁藥品，並提供科學和監管建議。
Cilastatin is an enzymatic dipeptidase-1 (DPEP1) inhibitor approved by the FDA in 1985 for use as fixed combination with imipenem to treat different types of bacterial infections. Arch has method-of-use patents for repurposing cilastatin as a treatment for acute kidney injury (AKI) in several jurisdictions, including North America and Europe. There is no commercial history of cilastatin as a stand-alone drug product.
西司他丁是一種酶促二肽肽酶-1（DPEP1）抑制劑，1985年已被FDA批准與頭孢哌酮固定聯合使用，用於治療不同類型的細菌感染。Arch在多個司法管轄區都擁有將西司他丁重新用於預防急性腎損傷（AKI）的專利。
The drug has a slightly different mechanism of action compared with Arch's novel drug candidate, LSALT peptide (Metablok) a non-enzymatic DPEP1 inhibitor. Whereas LSALT peptide specifically blocks DPEP1-mediated inflammation in the kidney, lungs and liver, cilastatin has off target-effects that prevent toxin uptake in the kidneys. As such, cilastatin is particularly effective for toxin-related AKI.
與Arch的新型藥物候選品LSALt肽（Metablok）非酶促二肽肽酶-1（DPEP1）抑制劑相比，西司他丁具有稍微不同的作用機制。LSALt肽專門阻止腎、肺和肝臟中DPEP1介導的炎症，而西司他丁有非靶向效應，可以防止毒素在腎臟中被攝取。因此，西司他丁對毒素相關AKI特別有效。
The PONTIAC trial builds on research published by lead Arch scientists and their colleagues in JCI (The Journal of Clinical Investigation) in 2018, when cilastatin was shown in pre-clinical models to effectively inhibit leukocyte recruitment and drug toxin uptake in the kidney, thereby preventing AKI caused by radiographic contrast.
PONTIAC試驗建立在Arch公司領先科學家及其同事於2018年在《臨床研究雜誌》（JCI）中發表的研究基礎上。當時西司他丁在臨床前模型中被證明可以有效抑制白細胞的招募和藥物毒素的吸收，從而預防由成像對比引起的AKI。
Today's announcement provides Arch's drug development program with a second target indication to prevent acute injury to the kidneys. The Company is currently dosing patients with its lead drug candidate, LSALT peptide, in an ongoing, international Phase II study targeting cardiac surgery-associated AKI (CS-AKI).
今天的公告爲Arch公司的藥物開發計劃提供了第二個預防腎臟急性損傷的目標指示。該公司目前正在進行重要的國際II期研究，該研究以LSALt肽爲主要藥物候選品，針對心臟手術相關AKI（CS-AKI）。
Quote from Mr. Richard Muruve, CEO Arch Biopartners:
Arch Biopartners首席執行官Richard Muruve先生說：“我們很高興看到CHREB的倫理批准，期待卡爾加里醫院的CS-AKI 二期試驗招募患者。我們對土耳其的五個招募醫院的試驗進展滿意。加拿大首次注射試劑，先在卡爾加里醫院，隨後是我們在多倫多的兩個醫院，將爲整個試驗增添助力。
"We are excited to be the industry partner of the PONTIAC trial while we continue to sponsor the Phase II trial for LSALT peptide targeting CS-AKI. The PONTIAC and CS-AKI trials combined are targeting about half of all AKI cases occurring in hospitals today. We are very driven to complete these trials and improve global kidney care with the first ever therapeutics to prevent acute kidney injury."
“我們很高興成爲PONTIAC試驗的工業夥伴，同時我們繼續贊助針對CS-AKI的LSALt肽II期試驗。PONTIAC和CS-AKI試驗的結合正在針對今天醫院中發生的大約一半AKI病例。我們非常努力地完成這些試驗，並通過首個預防急性腎損傷的藥物改善全球腎臟護理。”
About AKI
關於AKI
AKI reflects a broad spectrum of clinical presentations ranging from mild injury to severe injury that may result in permanent and complete loss of renal function. Clinically, the causes of AKI include sepsis, ischemia-reperfusion injury, and various endogenous as well as exogenous (drug) toxins. There is no specific therapeutic treatment available in the market today that prevents AKI. In the worst cases, the kidneys fail, requiring dialysis or kidney transplantation for patient survival.
AKI反映了從輕度損傷到嚴重損傷的廣泛臨床表現，可能導致腎功能的永久性和完全喪失。臨床上，AKI的原因包括敗血症、缺血再灌注損傷以及各種內源性以及外源性（藥物）毒素。目前市場上沒有特定的治療方法可以預防AKI。在最糟糕的情況下，腎臟會失敗，需要透析或腎移植來維持患者的生命。
Drug toxins cause approximately 30% of AKI cases in hospitalized patients and include a wide range of pharmaceutical drugs such as antibiotics (vancomycin, aminoglycosides), chemotherapeutic agents and radiographic contrast. Additionally, AKI related to cardiac surgery (CS-AKI) accounts for up to 20% of in-hospital AKI cases.
藥物毒素導致住院患者的AKI病例約佔30%，包括許多藥品，如抗生素（萬古黴素，氨基糖苷類藥物）、化療藥物和成像對比劑等。此外，與心臟手術有關的AKI（CS-AKI）佔住院AKI病例的20%。
About Cilastatin
關於cilastatin
Cilastatin was originally developed in the early 1980s by Merck Sharp & Dohme Research Laboratories to limit DPEP1's role in the breakdown of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as fixed combination with imipenem to treat different types of bacterial infections. This fixed combination, approved by the FDA in 1985, is currently marketed under different names, including Primaxin (USA, UK, Australia, Italy), Tienam (Spain, Belgium) or Zienam (Germany). Patents for imipenem and cilastatin have expired and the combination drug is currently in a generic phase. There is no commercial history of cilastatin as a stand-alone drug product.
西司他丁最初是由 默沙東研究實驗室在1980年代初發展出來的，以限制DPEP1在β-內酰胺類抗生素亞胺基青黴素用於系統感染的治療中的作用。西司他丁已獲得FDA批准，與頭孢哌酮固定聯合使用，用於治療不同類型的細菌感染。這種固定聯合用藥於1985年獲得FDA批准，並目前在不同國家以不同名稱銷售，包括Primaxin（美國、英國、澳洲、意大利）、Tienam（西班牙、比利時）或Zienam（德國）。亞胺基青黴素和西司他丁的專利已過期，聯合用藥目前處於一種通用藥階段。西司他丁作爲獨立藥物沒有商業歷史。
About Arch Biopartners
關於Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury. The Company is developing a platform of new drugs to prevent inflammation injury in the kidneys, lungs and liver via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem.
Arch生物合作伙伴公司（Arch Biopartners Inc.）是一個致力於預防急性腎損傷的晚期臨床試驗公司。該公司正在開發一系列新藥，通過二肽酶-1（DPEP1）途徑，預防腎、肺和肝臟中的炎症損傷，這些藥物對許多常見的損傷和疾病的器官炎症都具有重要意義。
For more information on Arch Biopartners' science and drug platform, please visit:
欲了解更多Arch Biopartners的科學和藥物平台信息，請訪問：
For investor information and other public documents the company has also filed on SEDAR+, please visit
欲了解有關Arch Biopartners的投資者信息和公司在SEDAR+上提交的其他公共文件，請訪問
The Company has 64,650,633 common shares outstanding.
該公司共有64650633股普通股流通。
Forward-Looking Statements
前瞻性聲明
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management's current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading "Business Risks and Uncertainties". As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval ("SEDAR") website at .
本新聞稿包含根據適用的加拿大證券法的前瞻性聲明，涉及我們未來業績，流動性和資本資源的預期，以及針對二肽酶-1（DPEP1）途徑的我們藥物候選品的持續臨床開發，包括與LSALT肽（Metablok）或cilastatin相關的我們的臨床試驗的結果，我們藥物候選品的成功商業化和營銷，無論我們是否將在加拿大，美國，歐洲和其他國家獲得，以及獲得監管批准的時間和費用，我們籌集資金以資助我們的業務計劃，我們的藥物候選品與競爭對手開發的藥物候選品的功效相比，我們的關鍵管理人員保留和吸引的能力，以及我們知識產權組合的廣度和保護能力。 這些陳述基於管理層的當前期望和信念，包括某些因素和假設，如我們最近的年度審計財務報表以及相關管理討論和分析中在“業務風險和不確定性”標題下所述。 由於這些風險和不確定性，或其他未知的風險和不確定性，我們的實際結果可能與任何前瞻性聲明中所包含的結果有所不同。 雖然並非所有前瞻性聲明都包含這些識別詞，但“相信”，“可能”，“計劃”，“將”，“估計”，“繼續”，“預期”和類似用語旨在識別前瞻性聲明。 我們未承擔更新前瞻性聲明的義務，除非法律要求。 有關Arch Biopartners Inc.的其他信息，包括我們最近的年度審計財務報表，請訪問加拿大證券管理機構的電子文件分析和檢索系統（“SEDAR”）網站。
The science and medical contents of this release have been approved by the Company's Chief Science Officer
本發佈稿的科學和醫學內容已獲公司首席科學官批准
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release
TSX創業公司交易所及其監管服務提供商（即TSX創業公司交易所政策所定義的那一方）不對此發佈的充分性或準確性負責。
CONTACT: For more information, please contact:
Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.
647-428-7031
info@archbiopartners.com
聯繫人:了解更多信息，請聯繫：
Richard Muruve
首席執行官
Arch Biopartners, Inc.
647-428-7031
info@archbiopartners.com
譯文內容由第三人軟體翻譯。