Arch Biopartners Announces Start of Patient Recruitment in Phase II PONTIAK Trial Targeting Drug-Toxin-Related Acute Kidney Injury (AKI)
Arch Biopartners (OTCQB: ACHFF) has initiated patient recruitment for its Phase II PONTIAK trial, evaluating cilastatin's effectiveness in preventing drug-toxin-related Acute Kidney Injury (AKI). The study will enroll 698 patients across five hospital sites in Alberta, Canada.
The trial has secured substantial funding, including $1.5 million from the Canadian Institutes of Health Research and $400,000 from the Accelerating Clinical Trials initiative. Arch Biopartners has manufactured the first standalone cilastatin drug product for the trial and is exploring opportunities to expand the study to the United States.
Arch Biopartners (OTCQB: ACHFF) ha avviato il reclutamento dei pazienti per il suo studio di Fase II PONTIAK, che valuta l'efficacia del cilastatina nella prevenzione dell'Acute Kidney Injury (AKI) causata da farmaci tossici. Lo studio arruolerà 698 pazienti in cinque ospedali della provincia di Alberta, Canada.
La sperimentazione ha ottenuto finanziamenti significativi, tra cui 1,5 milioni di dollari dai Canadian Institutes of Health Research e 400.000 dollari dall'iniziativa Accelerating Clinical Trials. Arch Biopartners ha prodotto il primo farmaco a base di cilastatina indipendente per lo studio e sta valutando la possibilità di estendere la ricerca negli Stati Uniti.
Arch Biopartners (OTCQB: ACHFF) ha iniciado el reclutamiento de pacientes para su ensayo de Fase II PONTIAK, que evalúa la eficacia de cilastatina para prevenir la lesión renal aguda (AKI) relacionada con toxinas farmacológicas. El estudio inscribirá a 698 pacientes en cinco hospitales de Alberta, Canadá.
El ensayo ha asegurado financiamiento considerable, incluyendo 1,5 millones de dólares de los Canadian Institutes of Health Research y 400,000 dólares de la iniciativa Accelerating Clinical Trials. Arch Biopartners ha fabricado el primer producto farmacéutico independiente de cilastatina para el ensayo y está explorando oportunidades para expandir el estudio a Estados Unidos.
Arch Biopartners (OTCQB: ACHFF)는 약물 독소 관련 급성 신손상(AKI) 예방을 위한 시라스타틴의 효과를 평가하는 2상 PONTIAK 임상시험의 환자 모집을 시작했습니다. 이 연구는 캐나다 앨버타주의 다섯 개 병원에서 698명의 환자를 등록할 예정입니다.
본 임상시험은 캐나다 보건연구소(Canadian Institutes of Health Research)로부터 150만 달러, 임상시험 가속화 이니셔티브(Accelerating Clinical Trials)로부터 40만 달러의 상당한 자금을 확보했습니다. Arch Biopartners는 임상시험을 위해 최초의 독립형 시라스타틴 의약품을 제조했으며, 미국으로 연구 확장 기회를 모색 중입니다.
Arch Biopartners (OTCQB : ACHFF) a lancé le recrutement des patients pour son essai de phase II PONTIAK, évaluant l'efficacité du cilastatine dans la prévention des lésions rénales aiguës (AKI) liées aux toxines médicamenteuses. L'étude recrutera 698 patients dans cinq hôpitaux situés en Alberta, au Canada.
L'essai a obtenu un financement important, incluant 1,5 million de dollars des Instituts de recherche en santé du Canada et 400 000 dollars de l'initiative Accelerating Clinical Trials. Arch Biopartners a fabriqué le premier produit médicamenteux autonome à base de cilastatine pour l'essai et explore les possibilités d'étendre l'étude aux États-Unis.
Arch Biopartners (OTCQB: ACHFF) hat mit der Rekrutierung von Patienten für seine Phase-II-Studie PONTIAK begonnen, in der die Wirksamkeit von Cilastatin zur Verhinderung von medikamentenbedingtem akutem Nierenschaden (AKI) untersucht wird. Die Studie wird 698 Patienten an fünf Krankenhäusern in Alberta, Kanada, einschließen.
Die Studie hat erhebliche Mittel erhalten, darunter 1,5 Millionen US-Dollar von den Canadian Institutes of Health Research und 400.000 US-Dollar von der Initiative Accelerating Clinical Trials. Arch Biopartners hat das erste eigenständige Cilastatin-Arzneimittel für die Studie hergestellt und prüft Möglichkeiten, die Studie auf die Vereinigten Staaten auszuweiten.
- Secured total funding of $1.9 million for the Phase II trial
- Successfully manufactured first-ever standalone cilastatin drug product
- Large patient enrollment target of 698 participants indicates robust study design
- Potential expansion opportunities to US market under FDA application
- Trial is investigator-led rather than company-sponsored, limiting direct control
- Study currently limited to Canadian sites only
TORONTO, July 22, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the investigator-led Phase II trial titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTIAK) has commenced patient recruitment at its primary clinical sites in Alberta, Canada.
The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with nephrotoxic pharmaceuticals, which include commonly used drugs such as antibiotics, chemotherapy agents, and imaging dyes, some of which are known to cause kidney damage as a side effect. The trial plans to enrol approximately 698 patients in five hospital sites in Alberta.
The PONTIAK clinical team, based at the Universities of Calgary and Alberta, secured
Arch Biopartners recently manufactured the first-ever, stand-alone cilastatin drug product and has provided the drug supply for the trial. While the trial is investigator-led and independently funded, the Company is also evaluating opportunities to support a complementary arm of the study in another jurisdiction, such as the United States under an application to the U.S. Food and Drug Administration.
Quote from Richard Muruve, CEO, Arch Biopartners:
“Congratulations to the PONTIAK team for achieving this milestone and beginning patient enrolment. This marks an important advancement in evaluating cilastatin as a potential first-in-class treatment to prevent AKI caused by exogenous toxins from several commonly used pharmaceutical products.”
About 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 on the market that prevents AKI. In the worst cases, the kidneys fail, requiring dialysis or kidney transplantation for patient survival.
Drug toxins cause approximately
About Cilastatin
Cilastatin was originally developed in the early 1980s by Merck Sharp & Dohme Research Laboratories to limit the role of dipeptidase-1 (DPEP1) in the breakdown of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as a 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). Composition of matter 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.
Cilastatin 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. Arch Biopartners owns and has exclusively licensed method-of-use patents to repurpose cilastatin as a new treatment targeting AKI.
The PONTIAK Phase II clinical trial is registered on ClinicalTrials.gov under identifier NCT06886464.
About Arch Biopartners
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury and organ damage caused by inflammation. The Company is developing a platform of novel drugs targeting the dipeptidase-1 (DPEP1) inflammation pathway prevalent in the kidneys, lungs, and liver.
LSALT peptide and cilastatin are lead drug candidates in separate Phase II trials targeting acute kidney injury caused by inflammation and toxins, respectively. Both indications represent significant unmet medical needs in global kidney care.
For more science details: www.archbiopartners.com/our-science
For investor materials and filings: www.archbiopartners.com/investor-hub
The Company has 65,906,366 common shares outstanding.
For more information, please contact:
| Aaron Benson Director of Communications Arch Biopartners, Inc. 647-428-7031 Send a message using the Contact Form at: www.archbiopartners.com/contact-us |
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 scientific and medical content in this release has 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
FAQ
What is the purpose of Arch Biopartners' (ACHFF) PONTIAK Phase II trial?
How many patients will be enrolled in ACHFF's PONTIAK trial?
How much funding has been secured for Arch Biopartners' PONTIAK trial?
What is unique about Arch Biopartners' cilastatin drug product?
Is Arch Biopartners planning to expand the PONTIAK trial to other regions?
