Vancomycin Hydrochloride

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 $1.5 million in funding for the Phase II trial from the Canadian Institutes of Health Research (CIHR), along with $400,000 under the Accelerating Clinical Trials (ACT) initiative aimed at evaluating Canadian biotechnologies using randomized controlled trials. 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 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). 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 BensonDirector of CommunicationsArch Biopartners, Inc. 647-428-7031Send 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

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.UPDATED: Wednesday, July 2 at 10:30 a.m. ETA little over a year after Merck & Co. scored U.S. approval for its pulmonary arterial hypertension (PAH) newcomer Winrevair (sotatercept), the New Jersey drugmaker has locked in an expedited review timeline to potentially update the medicine’s label.The FDA has granted priority review to Merck’s application and set a target date of Oct. 25 to decide whether to revise Winrevair’s label with impressive morbidity and mortality data from Merck’s phase 3 ZENITH trial.The study, which was the first late-stage PAH outcomes trial to leverage a primary endpoint consisting of major morbidity and mortality events, recently stopped early on the advice of a third-party data monitoring committee thanks to “overwhelming efficacy,” Merck noted in a July 2 press release.In the trial, Winrevair led to a 76% reduction in the risk of a composite of all-cause death, lung transplantation and hospitalization in PAH patients for at least 24 hours compared to placebo.Winrevair was approved by the FDA last March as an add-on therapy to standard of care in a subset of PAH patients defined by the World Health Organization (WHO). Merck picked up the drug in its $11.5 billion acquisition of Acceleron. Analysts have predicted peak sales of Winrevair could land anywhere between $2 billion and $4 billion. Over in Europe, Vertex Pharmaceuticals is continuing to grow its cystic fibrosis (CF) empire with a European Commission (EC) approval of its once-a-day triple therapy Alyftrek—comprising deutivacaftor, tezacaftor and vanzacaftor—in CF patients ages 6 years and older who have at least one non-class 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.The EC gave its blessing after reviewing data from two head-to-head studies that found Alyftrek was non-inferior to Vertex’s entrenched CF therapy Kaftrio in combination with ivacaftor on a standard measure of lung function and superior when it came to reducing sweat chloride and spurring greater improvements in CFTR function.The EC green light significantly expands the reach of Vertex’s CF therapeutics overseas, with some 31,000 CF patients in the European Union (EU) now eligible to receive the new therapy, the company pointed out.The drug is expected to launch in Ireland, Denmark and Germany first as Vertex continues to work out reimbursement deals with other EU member states.The thumbs up from the EC comes after the FDA cleared Alyftrek in a similar patient population in late December. Elsewhere, London-based Hikma has won the FDA’s blessing for a new, ready-to-infuse formulation of the antibiotic vancomycin for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adults and children as young as 1 month or older.Hikma will market the novel formulation of the well-established anti-infective under the commercial moniker Tyzavan, which the company says stands for “time-saving vancomycin.”The green light earns Tyzavan the distinction of being the only vancomycin product that can be kept at room temperature and doesn’t require compounding, thawing, activation or dilution before use, which ought to hasten treatment by reducing preparation steps, Hikma said in a July 2 press release.U.S. sales of injectable vancomycin approached $200 million in 2024, Hikma noted, citing data from the health information and research firm IQVIA.