Cilastatin Sodium

TORONTO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it had a pre-investigational new drug application (PIND) meeting with the U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products (DCRP) on February 23, 2024 to discuss Arch’s plan to repurpose cilastatin as a new treatment to prevent toxin related acute kidney injury (AKI). Currently, there are no specific treatments for the prevention or treatment of AKI. Arch has the opportunity to sponsor a Phase II trial for cilastatin in toxin-related AKI targeting either nephrotoxic drug and/or rhabdomyolysis-associated AKI (explained further below). The PIND meeting provided the Arch team with guidance from the FDA for the content of a future IND application for cilastatin. An IND application is a request to the FDA for authorization to administer a new drug to patients in a human trial. The Arch team received clarity on several items including cilastatin pharmacology; manufacturing of a cilastatin drug product; design of phase II study protocol targeting toxin-related AKI; and the regulatory path that would lead to a New Drug Application (NDA). Arch is acting as an industry partner with clinical researchers in Canada and the United States who are planning to conduct two separate phase II clinical studies respectively for toxin-related AKI in late 2024. Arch management does not have plans to raise funds during 2024 in the capital markets for cilastatin trials. The Company will support these studies by acting as a partner for grant funding opportunities, providing cilastatin drug product, scientific advice, and pursuing regulatory approvals. Arch management is overseeing the development and manufacturing of a first-ever, stand-alone cilastatin drug product. Arch has arranged for the production of the first lot of a cilastatin to occur during the summer of 2024. Arch has method of use patents in several jurisdictions for repurposing cilastatin as a treatment for AKI. The patents are either proprietary or exclusively licensed to Arch. Quote from Richard Muruve, CEO of Arch Biopartners Inc: “The PIND meeting was the first major milestone in the effort to commercialize cilastatin, Arch’s second drug targeting DPEP-1. Third-party research and clinical interest to test cilastatin as a first ever treatment for both rhabdomyolysis-associated AKI and drug toxin-related AKI have provided the catalyst for Arch to advance this technology toward an NDA in parallel with the LSALT peptide program. We look forward to working with our research and clinical collaborators to establish cilastatin and DPEP-1 inhibition as a new treatment to prevent toxin-related AKI.” About Cilastatin Cilastatin is an enzymatic dipeptidase-1 (DPEP-1) inhibitor originally developed in the early 80´s by Merck Sharp & Dohme Research Laboratories (MSDRL) 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 DPEP-1 inhibitor. Whereas LSALT peptide specifically blocks DPEP-1-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 the 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 toxins. Exogenous toxins include a wide range of pharmaceutical drugs such as antibiotics (vancomycin, aminoglycosides), chemotherapeutic agents and radiographic contrast. The incidence of AKI is approximately 30% of all hospitalized patients receiving nephrotoxic medications. Endogenous toxins include heme-pigments such as myoglobin released during severe muscle injury (rhabdomyolysis) due to crush or blunt trauma, prolonged immobilization or drugs. Heme-pigments are avidly taken up by the kidney where they directly damage cells resulting in AKI. The kidney is particularly susceptible to heme-pigment induced injury with AKI occurring in up to 50% of patients experiencing rhabdomyolysis. As stated above, cilastatin is particularly suited to preventing AKI caused by exogenous and endogenous 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 acute kidney injury (AKI) induced by multiple nephrotoxic drugs (exogenous toxins) and/or heme-pigments (endogenous 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 new drug candidates that inhibit inflammation in the lungs, kidneys, and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem. For more information on Arch Biopartners' science and technologies, please visit: For investor information and other public documents the company has also filed on SEDAR, please visit The Company has 62,755,633 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), 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 . 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

SILVER SPRING, Md., May 23, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines. "The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like Acinetobacter baumannii-calcoaceticus complex," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research. "Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals." Acinetobacter baumannii-calcoaceticus complex (henceforth referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family. These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia. A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited. Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam. Sulbactam kills A. baumannii whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii. Xacduro is administered by intravenous infusion. Xacduro's efficacy was established in a multicenter, active-controlled, open-label (investigator-unblinded, assessor-blinded), non-inferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. Patients received either Xacduro or colistin (a comparator antibiotic) for up to 14 days. Both treatment arms also received an additional antibiotic, imipenem/cilastatin, as background therapy for potential HABP/VABP pathogens other than Acinetobacter baumannii-calcoaceticus complex. The primary measure of efficacy was mortality from all causes within 28 days of treatment in patients with a confirmed infection with carbapenem-resistant A. baumannii. Of those who received Xacduro, 19% (12 of 63 patients) died, compared to 32% (20 of 62 patients) who received colistin; this demonstrated that Xacduro was noninferior to colistin. The most common adverse reaction with Xacduro was liver function test abnormalities. Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and Clostridiodes difficile-associated diarrhea. Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, sulbactam or other beta-lactam antibacterial drugs. The FDA granted Xacduro Fast Track, Qualified Infectious Disease Product and Priority Review designations for this application. The FDA granted the approval of Xacduro to Entasis Therapeutics. Additional Resources: Antimicrobial Resistance Information from FDA CDC: Acinetobacter in Healthcare Settings Media Contact: Chanapa Tantibanchachai, 202-384-2219 Consumer Inquiries: Email or 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration