ARCH Arch Biopartners Inc

Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the clinical team leading the upcoming investigator-led trial, titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTiAK), has received a No Objection Letter (NOL) from Health Canada to proceed with the trial.

PONTiAK is a 700-patient Phase II trial (revised from 900 patients) evaluating the efficacy of cilastatin in preventing AKI caused by several drugs, including certain antibiotics, chemotherapeutic agents, and radiographic contrast.

The PONTiAK clinical team of investigators, based at the Universities of Calgary and Alberta, was awarded $1,500,000 by the Canadian Institutes of Health Research (CIHR) to fund the trial. The 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 PONTiAK trial at up to five hospital sites in Alberta.

The next steps for the PONTiAK team include the preparation of the hospital sites to conduct the study while working to obtain approvals from the local Research Ethics Board (REB) and Alberta Health Services (AHS) Operational Approval.

Arch is acting as a study partner for grant funding opportunities and providing cilastatin drug product to support the trial. While the PONTiAK team continues to prepare the hospital sites and seek approvals from REB and AHS, Arch will evaluate opportunities to sponsor a new arm of the PONTiAK study in another jurisdiction, such as the United States or Europe.

Quote from Richard Muruve, CEO, Arch Biopartners

“Congratulations to the PONTiAK team for receiving the No Objection Letter from Health Canada. This milestone is an important step forward for the Phase II trial using cilastatin to target drug-toxin-related AKI.”

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 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.

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). 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.

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.

Its lead drug candidates, LSALT peptide and cilastatin, are being developed to target kidney injury caused by inflammation or toxins, respectively, both of which are significant unmet medical needs.

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 filed on SEDAR+, please visit www.archbiopartners.com/investor-hub

The Company has 65,590,254 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