Arch Biopartners Announces Toronto General Hospital Ethics Board Approval to Join the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI)
Arch Biopartners (ACHFF) has received ethics approval from the University Health Network (UHN) Research Ethics Board for Toronto General Hospital (TGH) to participate in their ongoing Phase II trial of LSALT peptide. The trial focuses on preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI).
TGH will become the seventh global site and second Canadian location for patient recruitment in this clinical study. The company plans to reduce recruitment in Turkey while increasing Canadian participation to diversify the trial's geographic and demographic data coverage.
Arch Biopartners (ACHFF) ha ricevuto l'approvazione etica dal Comitato Etico della University Health Network (UHN) per il Toronto General Hospital (TGH) per partecipare al loro studio di Fase II in corso sul peptide LSALT. Lo studio è incentrato sulla prevenzione e il trattamento dell'insufficienza renale acuta associata a interventi chirurgici cardiaci (CS-AKI).
Il TGH diventerà il settimo sito a livello globale e la seconda sede canadese per il reclutamento dei pazienti in questo studio clinico. L'azienda prevede di ridurre il reclutamento in Turchia aumentando invece la partecipazione canadese, al fine di diversificare la copertura geografica e demografica dei dati dello studio.
Arch Biopartners (ACHFF) ha recibido la aprobación ética de la Junta de Ética en Investigación de la University Health Network (UHN) para el Toronto General Hospital (TGH) para participar en su ensayo de Fase II en curso del péptido LSALT. El ensayo se centra en la prevención y el tratamiento de la lesión renal aguda asociada a cirugía cardíaca (CS-AKI).
El TGH se convertirá en el séptimo sitio global y en la segunda ubicación canadiense para el reclutamiento de pacientes en este estudio clínico. La compañía planea reducir el reclutamiento en Turquía mientras aumenta la participación canadiense para diversificar la cobertura geográfica y demográfica de los datos del ensayo.
Arch Biopartners (ACHFF)는 토론토 제너럴 병원(TGH)을 위한 University Health Network(UHN) 연구 윤리 위원회로부터 LSALT 펩타이드에 대한 진행 중인 2상 임상시험 참여에 대한 윤리 승인을 받았습니다. 이 임상시험은 심장 수술 관련 급성 신손상(CS-AKI)의 예방 및 치료에 중점을 두고 있습니다.
TGH는 이번 임상 연구에서 환자 모집을 위한 세계 7번째 사이트이자 캐나다 내 두 번째 장소가 될 예정입니다. 회사는 터키에서의 모집을 줄이는 대신 캐나다 참여를 늘려 임상시험의 지리적 및 인구통계학적 데이터 범위를 다양화할 계획입니다.
Arch Biopartners (ACHFF) a obtenu l'approbation éthique du comité d'éthique de la University Health Network (UHN) pour le Toronto General Hospital (TGH) afin de participer à leur essai de phase II en cours sur le peptide LSALT. Cet essai vise à prévenir et traiter l'insuffisance rénale aiguë associée à la chirurgie cardiaque (CS-AKI).
Le TGH deviendra le septième site mondial et la deuxième implantation canadienne pour le recrutement des patients dans cette étude clinique. L'entreprise prévoit de réduire le recrutement en Turquie tout en augmentant la participation canadienne afin de diversifier la couverture géographique et démographique des données de l'essai.
Arch Biopartners (ACHFF) hat die Ethikgenehmigung vom Research Ethics Board des University Health Network (UHN) für das Toronto General Hospital (TGH) erhalten, um an deren laufender Phase-II-Studie zum LSALT-Peptid teilzunehmen. Die Studie konzentriert sich auf die Prävention und Behandlung der akutem Nierenschädigung im Zusammenhang mit Herzoperationen (CS-AKI).
Das TGH wird der siebte globale Standort und der zweite kanadische Standort für die Patientenrekrutierung in dieser klinischen Studie sein. Das Unternehmen plant, die Rekrutierung in der Türkei zu reduzieren und gleichzeitig die kanadische Beteiligung zu erhöhen, um die geografische und demografische Datenabdeckung der Studie zu diversifizieren.
- Expansion of trial sites to 7 locations globally
- Geographic diversification of trial data through increased Canadian recruitment
- Ethics approval received for major Canadian hospital (Toronto General Hospital)
- Reduction of patient recruitment in Turkey
TORONTO, April 22, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the University Health Network (UHN) Research Ethics Board has granted approval for Toronto General Hospital to participate in the Company’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
With this ethics approval in place and all training and preparations complete, the clinical team at Toronto General Hospital (TGH) is now cleared to begin patient recruitment. TGH will be the seventh site to be activated globally and the second site to recruit patients in Canada.
Quote from Mr. Richard Muruve, CEO Arch Biopartners:
“We are pleased to receive ethics approval from the UHN Research Ethics Board and to initiate patient recruitment at Toronto General Hospital for our CS-AKI Phase II trial. Going forward, we plan to reduce recruitment in Turkey and increase recruitment in Canada to broaden the geographic and demographic data of our trial.”
About the CS-AKI Phase II Trial
The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients.
The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.
Details of the Phase II trial, entitled “Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov.
CS-AKI and LSALT peptide
CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. In the worst cases of AKI, the kidneys fail, requiring kidney dialysis or kidney transplant for survival.
LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs, and liver. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. and can be found along with the latest peer-reviewed publications about DPEP1 and LSALT peptide at the Company’s website.
Incidence of CS-AKI
Acute kidney injury is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries, which increase the risk of AKI. The reported prevalence of CS-AKI is up to
About Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury (AKI) and organ damage caused by inflammation and toxins. The Company is advancing a pipeline of drug candidates that includes LSALT peptide, a first-in-class inhibitor of the DPEP1 inflammation pathway, and cilastatin, a repurposed drug with off-target effects that help block toxin uptake into the kidneys – two approaches addressing distinct and urgent causes of AKI.
For more information on Arch Biopartners’ science and drug platform, please visit: www.archbiopartners.com/our-science
For investor information and other public documents the company has also filed on SEDAR+, please visit www.archbiopartners.com/investor-hub
The Company has 65,906,366 common shares outstanding.
Forward-Looking Statements
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 (DPEP-1) 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 www.sedarplus.ca .
The science and medical contents of this release have been approved by the Company’s Chief Science Officer
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
For more information, please contact: Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
FAQ
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