Arch Biopartners Announces GMP Manufacturing of Cilastatin Drug Product

Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced that Dalton Pharma Services (Dalton) has completed the good manufacturing practice (GMP) glass vial filling stage for cilastatin, the Company’s second drug candidate for preventing acute kidney injury (AKI).

Over the next six to eight weeks Dalton will be completing the quality control process which will culminate with the release of a first-ever, stand-alone cilastatin drug product to be used in a Phase II trial targeting drug toxin related AKI in hospitalized patients.

Arch has agreed to be an industry partner with a group of Canadian clinical researchers in a planned Phase II clinical trial targeting drug toxin-related AKI, which is expected to start in late 2024. The Company will be acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice.

Arch has method of use patents in several jurisdictions including North America and Europe for repurposing cilastatin as a treatment for AKI. The patents are proprietary and/or exclusively licensed to Arch. Today’s announcement marks the completion of an important milestone in the Company’s plans to repurpose cilastatin as a new treatment to prevent toxin related AKI.

About Cilastatin

Cilastatin is an enzymatic dipeptidase-1 (DPEP1) inhibitor originally developed in the early 1980´s by Merck Sharp & Dohme Research Laboratories to limit the renal metabolism of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as fixed combination with imipenem for IV administration to treat different types of bacterial infections. This fixed combination is currently marketed under different names, including Primaxin® (USA, UK, Australia, Italy), Tienam® (Spain, Belgium) or Zienam® (Germany). The combination imipenem/cilastatin was approved by the FDA in 1985. 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 also has off target-effects that prevent toxin uptake in the kidneys. Thus, cilastatin is particularly effective for toxin-related AKI, but not suitable for other forms of non-toxin related AKI targeted by LSALT peptide.

Cilastatin as a potential treatment for 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 kidney dialysis or kidney transplant for survival.

Exogenous toxins include a wide range of pharmaceutical drugs such as antibiotics (vancomycin, aminoglycosides), chemotherapeutic agents and radiographic contrast. Drug toxin-induced AKI represent approximately 30% of all AKI in hospitalized patients.

As stated above, cilastatin is particularly suited to preventing AKI caused by drug toxins due to a unique off-target effect that blocks their uptake into the kidney tissue. Several in vitro and in vivo studies indicate that cilastatin prevents AKI induced by multiple nephrotoxic drugs (exogenous toxins).

About Arch Biopartners

Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The Company is developing a platform of new drugs to prevent inflammation in the kidneys, liver and lungs via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem.

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 64,250,633 common shares outstanding.

About Dalton Pharma Services

Dalton Pharma Services is a leading North American cGMP pharmaceutical organisation providing integrated drug discovery, development and manufacturing services. Dalton is US FDA-inspected, Health Canada-licensed and brings more than 35 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility and quality.

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 (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 www.sedarplus.ca.