DPEP1

FLORHAM PARK, N.J.--( BUSINESS WIRE )--Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will have 22 scientific presentations across the company’s infectious disease portfolio at IDWeek 2024 (October 16-19, 2024) in Los Angeles, California. Key among Shionogi’s 13 data presentations for Fetroja® (cefiderocol) will be a new real-world evidence study including approximately 1,000 patients treated with cefiderocol from across the U.S. and Europe. This trial, known as PROVE, is the largest study to evaluate cefiderocol use in hospitalized patients with serious Gram-negative infections, the majority of whom were resistant to carbapenem antibiotics. Notably, Shionogi will have two oral presentations featuring nonclinical data evaluating cefiderocol activity against some of the most difficult-to-treat bacterial strains that were resistant to antibiotics, alone and in combination with xeruborbactam, an investigational beta-lactamase inhibitor that became part of the Shionogi pipeline with the acquisition of Qpex Biopharma, Inc. (hereafter “Qpex”) by Shionogi Inc. in 2023. “Here in the U.S., a core focus of our work includes continuing to evaluate real-world outcomes associated with the use of our antibiotic for the treatment of certain Gram-negative infections and ensuring we’re meeting the educational and practical needs of our customers and their patients,” said Nate McCutcheon, President and Chief Executive Officer, Shionogi Inc. “We’re proud to make this important medication available and we also recognize that ongoing innovation is critical in infectious disease. That’s why we recently announced plans to expand our global infectious disease and antimicrobial research operations in the U.S. through Qpex with the establishment of our first U.S.-based discovery laboratory in San Diego.” Shionogi is honored to announce that Michael N. Dudley, PharmD, President and CEO of Qpex will deliver the keynote address at the Society of Infectious Diseases Pharmacists (SIDP) Annual Meeting, taking place in conjunction with IDWeek. In addition to numerous scientific presentations at IDWeek, Shionogi will once again enable the infectious disease community to join the fight and take a stand against the global public health threat of antimicrobial resistance (AMR) with a new version of its award-winning AMR Warrior experience. All visitors to Shionogi’s Booth #322 will have the opportunity to create their own AMR Warrior and use the image to spread awareness amongst their own networks and communities. Shionogi’s presence at IDWeek will also include a sponsored Learning Lounge on Friday, October 18, at 10:15 AM PT, featuring Thomas Lodise, PharmD, PhD, Professor at the Albany College of Pharmacy and Health Sciences, entitled “Fetroja® (cefiderocol): An Overview of In Vitro, Clinical, and Real-world Data.” Summary of Presentations Cefiderocol data presentations at IDWeek will include: Oral #513: Cefiderocol Retains in vitro Activity Against Enterobacterales Non-Susceptible to beta-lactam-beta-lactamase Inhibitor Combinations Poster #650: In vitro Activity of Cefiderocol and Comparator Agents Against Global Enterobacterales Isolates from Hospitalized Patients with Pneumonia Collected as Part of the SENTRY Surveillance Program (2020-2022) Poster #1099: Correlation Analysis of Cefiderocol in vitro Activity and in vivo Efficacy Against Acinetobacter baumannii Strains with Difficult-to-Read MIC Endpoints Poster #1100: Activity of Cefiderocol and Comparator Agents Against Global Isolates of Stenotrophomonas maltophilia from the SENTRY Antimicrobial Surveillance Program (2020–2023) Poster #1360: Activity of Cefiderocol Against Carbapenem Non-susceptible Enterobacterales, Including Molecularly Characterized Multidrug-resistant Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1361: Cefiderocol Activity Against Pseudomonas aeruginosa , Including Resistant Subsets and Isolates Carrying Carbapenemase beta-lactamase Genes, from United States Hospitals (2020–2023) Poster #1362: Cefiderocol Activity Against Carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex, Including Molecularly Characterized Clinical Isolates, Causing Infections in United States Hospitals (2020–2023) Poster #1363: Cefiderocol Activity Against Clinical Enterobacterales Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1364: Cefiderocol Activity Against Pseudomonas aeruginosa Clinical Isolates Carrying Metallo-beta-lactamase Genes in United States and European Hospitals (2020–2023) Poster #1472: Cefiderocol Remains Highly Active Against Carbapenemase-Producing Enterobacterales Poster #1475: Real-World Effectiveness and Safety of Cefiderocol in the Treatment of Patients with Serious Gram-negative Bacterial Infections: Results of the PROVE Chart Review Study Poster #1484: In vitro Activity of Cefiderocol and Comparator Agents Against Non-fermentative Gram-negative Bacilli Isolated from Patients Hospitalized with Pneumonia as part of the SENTRY Global Surveillance Program (2020-2022) Poster #1530: Evaluation of Phenotypic Cross-Resistance Between Cefiderocol and beta-lactam/beta-lactamase Inhibitor Combinations Against Pseudomonas aeruginosa Isolates from US Medical Centers Xeruborbactam data presentations at IDWeek will include: Oral #514: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Acinetobacter baumannii Enriched in Isolates with Reduced Cefiderocol Susceptibility Poster #1110: The Impact of Xeruborbactam on in vitro Activity of Cefiderocol Against a Panel of Enterobacterales Enriched with Isolates with Reduced Cefiderocol Susceptibility For Full Prescribing Information for Fetroja® (cefiderocol), including approved Indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf . Shionogi’s scientific contributions at IDWeek will also include seven poster presentations featuring clinical, nonclinical and real-world evidence from its COVID-19 franchise. For more information, including a complete list of abstracts, please visit https://idweek.org/program/ . IDWeek attendees can learn more about Shionogi at Booth #322. About Shionogi in Infectious Disease Since 1953, Shionogi has been a leader in infectious disease discovery and commercialization. Our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Today, our global pipeline includes investigational agents developed to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi is partnering with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi has a landmark license and technology transfer agreement for cefiderocol with Global Antibiotic Research and Development Partnership (GARDP) and a collaboration agreement with the Clinton Health Access Initiative (CHAI) to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a Japanese research-driven pharmaceutical company committed to developing innovative medicines that address unmet medical needs for people worldwide. Since 1878, we have been harnessing the full potential of science to address global health challenges. Over the past six decades, we have discovered several novel antibiotics and medications for HIV and influenza. Today, we’ve focused on developing antibiotics for infections due to serious Gram-negative bacteria and antivirals for COVID-19. In addition to infectious disease, we are also advancing rare disease clinical programs in Fragile X syndrome and Pompe disease. Learn more at Shionogi.com . About Qpex Biopharma Inc., a Shionogi Group Company Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead program is based on xeruborbactam, an investigational beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit www.qpexbio.com . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

LABÈGE, France I September 03, 2024 I Antabio , a private biopharmaceutical company developing novel and highly differentiated antibacterial treatments for critical priority pathogens, with a particular focus on life-threatening respiratory infections, today announced that it has completed the Phase 1 clinical trial for MEM-ANT3310 in healthy volunteers. Antabio’s MEM-ANT3310 is a next generation broad-spectrum antibacterial combination that has been designed to address the growing problem of antimicrobial resistance in severe hospital infections. MEM-ANT3310 combines the well-known carbapenem meropenem (MEM) with ANT3310, a breakthrough serine-beta-lactamase (SBL) inhibitor that provides a unique coverage of priority Gram-negative pathogens including OXA-carbapenem-resistant Acinetobacter baumannii (CRAB), KPC- and OXA- carbapenem-resistant Enterobacterales (CRE), and Pseudomonas aeruginosa (PA). The Phase 1 clinical trial included 72 healthy volunteers across three parts and evaluated the safety, tolerability, and pharmacokinetic (PK) profile of Single and Multiple Ascending Doses (SAD/MAD) of the intravenous beta-lactamase inhibitor ANT3310, administered alone. The potential mutual PK interaction between ANT3310 and meropenem was investigated, followed by an assessment of the combination MEM-ANT3310 during multiple intravenous dosing. ANT3310 was well-tolerated at all doses with no serious adverse events, dose-limiting toxicities or clinically relevant abnormalities reported. The ANT3310 PK parameters were consistent with those determined from studies in rodent and non-rodent species and dose-dependent increases in exposure were observed. ANT3310 and meropenem demonstrated very compatible PK with no mutual PK interaction. This positive Phase 1 data supports further patient studies of MEM-ANT3310. “With matching PK and good tolerability, MEM-ANT3310 shows great promise to address serious infections whenever multidrug resistance is a concern in hospitalized patients.” said Marc Lemonnier, CEO of Antabio . “With a uniquely broad coverage, we believe MEM-ANT3310 will be very well positioned to meet the urgent medical needs in high-risk patients, especially when multidrug-resistant pathogens or polymicrobial infections are suspected”. Antabio is currently conducting a Phase 1 PK study of MEM-ANT3310 in subjects with impaired renal function and is planning a second PK study to assess the distribution of MEM-ANT3310 in the lung (epithelial lining fluid) in healthy volunteers. About MEM-ANT3310 Carbapenems such as meropenem are the cornerstone of therapies for many life-threatening infections. Resistance to carbapenems is considered a critical priority by the World Health Organisation (WHO) and Centre for Disease Control and Prevention (CDC) because it is a major cause of treatment failure, increased mortality, and huge economic costs. Bacteria resistant to carbapenems produce β-lactamase enzymes that render antibiotics, such as meropenem, ineffective. ANT3310 inhibits a broad range of β-lactamases, including the Klebsiella pneumoniae carbapenemases (KPC) and oxacillin-hydrolysing (OXA) type enzymes found in Carbapenem-Resistant Enterobacterales (CRE) and most importantly Carbapenem-Resistant Acinetobacter baumannii (CRAB). The combination of this potent β-lactamase inhibitor with the antibiotic meropenem (MEM-ANT3310) therefore provides a critical solution for the treatment of serious infections that may be caused by MDR pathogens, such as hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). MEM-ANT3310 has received qualified infectious disease product (QIDP) status from the FDA in 2020 for complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI) and HABP and VABP. About Antabio Antabio is a clinical stage biopharmaceutical company developing novel and highly differentiated antibacterial treatments of drug-resistant infections as defined by the CDC and WHO’s critical priority pathogens, with a particular focus on life-threatening respiratory infections, including carbapenem-resistant nosocomial pneumonia and chronic pulmonary diseases. The company’s lead program, MEM-ANT3310, is being developed for the treatment of hospital-acquired infections such as nosocomial pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) and carbapenem-resistant Enterobacterales (CRE). Antabio’s portfolio includes additional innovative preclinical programs addressing areas of highest unmet need in the antibacterial space. SOURCE: Antabio

Arch is repurposing cilastatin, a dipeptidase-1 inhibitor, as a new treatment for acute kidney injury (AKI) Cilastatin is particularly well suited to prevent AKI caused by drug toxins due to its unique off-target effects that block toxin uptake into the kidney tissue Arch continues to perform a Phase II trial for LSALT peptide targeting cardiac surgery-associated-AKI Drug toxins and CS-AKI account for up to 50% of all AKI occurring in hospitals, for which there is no treatment available Aug. 02, 2024 -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that cilastatin, the Company’s second drug candidate for preventing acute kidney injury (AKI), will participate in the upcoming investigator led trial entitled “Prevention Of NephroToxin Induced Acute kidney injury with Cilastatin” (PONTIAC). PONTIAC is a 900 patient Phase II trial that will evaluate the efficacy of the dipeptidase-1 inhibitor cilastatin for preventing AKI caused by drugs such as antibiotics, chemotherapeutic agents and radiographic contrast. The PONTIAC clinical team of investigators, based out of the Universities of Calgary and Alberta, was awarded $1,500,000 by the Canadian Institutes of Health Research (CIHR) to fund the trial. The clinical 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 PONTIAC trial. The PONTIAC clinical team sponsoring the trial is based in Calgary and is currently preparing to submit a Clinical Trial Application (CTA) to Health Canada to proceed with the trial by the fourth quarter of 2024. Arch is acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice. Cilastatin is an enzymatic dipeptidase-1 (DPEP1) inhibitor approved by the FDA in 1985 for use as fixed combination with imipenem to treat different types of bacterial infections. Arch has method-of-use patents for repurposing cilastatin as a treatment for acute kidney injury (AKI) in several jurisdictions, including North America and Europe. There is no commercial history of cilastatin as a stand-alone drug product. The drug 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. The PONTIAC trial builds on research published by lead Arch scientists and their colleagues in JCI (The Journal of Clinical Investigation) in 2018, when cilastatin was shown in pre-clinical models to effectively inhibit leukocyte recruitment and drug toxin uptake in the kidney, thereby preventing AKI caused by radiographic contrast. Today’s announcement provides Arch’s drug development program with a second target indication to prevent acute injury to the kidneys. The Company is currently dosing patients with its lead drug candidate, LSALT peptide, in an ongoing, international Phase II study targeting cardiac surgery-associated AKI (CS-AKI). Quote from Mr. Richard Muruve, CEO Arch Biopartners: “We are excited to be the industry partner of the PONTIAC trial while we continue to sponsor the Phase II trial for LSALT peptide targeting CS-AKI. The PONTIAC and CS-AKI trials combined are targeting about half of all AKI cases occurring in hospitals today. We are very driven to complete these trials and improve global kidney care with the first ever therapeutics to prevent acute kidney injury.” 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 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. Cilastatin was originally developed in the early 1980s by Merck Sharp & Dohme Research Laboratories to limit DPEP1’s role in the breakdown of imipenem, a β-lactam antibiotic used for the treatment of systemic infections. Cilastatin was approved for use as 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. Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing acute kidney injury. The Company is developing a platform of new drugs to prevent inflammation injury in the kidneys, lungs and liver via the dipeptidase-1 (DPEP1) pathway and are relevant for many common injuries and diseases where organ inflammation is an unmet problem. The content above comes from the network. if any infringement, please contact us to modify.