ADM

DUBLIN--( BUSINESS WIRE )--The "Sepsis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines. The assessment part of the report embraces, in depth Sepsis commercial assessment and clinical assessment of the pipeline products under development In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sepsis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve Sepsis. Sepsis Emerging Drugs Chapters This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sepsis Emerging Drugs Thymosin alpha 1: SciClone Pharmaceuticals Thymosin alpha 1, referred to as thymalfasin, is a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement. SciClone developed and launched Thymosin alpha 1, under the trade name Zadaxin, for the treatment of hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of COVID 2019 infections. Scientific and clinical studies have shown that Thymosin alpha 1 helps to stimulate and direct the body's immune response to eradicate infectious diseases, such as HBV, HCV, bacterial, and fungal infections; to fight certain cancers such as melanoma and liver cancer; and to enhance response to vaccines. Clinical trials have shown that Thymosin alpha 1 improves survival in patients in intensive care units being treated for sepsis from severe bacterial infections. The therapy is being evaluated in Phase III stage to treat Sepsis. Currently, the drug is in Phase III stage of its development for the treatment of sepsis. Enibarcimab: AdrenoMed AG Enibarcimab (HAM8101; former name: Adrecizumab) a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Enibarcimab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity. Enibarcimab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal. Currently, the drug is in Phase II stage of its development for the treatment of sepsis. M 6229: Matisse Pharmaceuticals Matisse's platform technology is based on the discovery that in many patients suffering from sepsis, proteins called histones are released by the innate immune system and dying cells into the blood stream, where they are toxic to other cells. Due to a self-enforcing cascade, people may die from organ failure within one or two days. Preclinical results have shown that by neutralizing the toxic histones with Matisse's product M6229, the negative cascade is terminated by neutralization of cationic histones by anionic M6229. Matisse claims to have identified an elegant solution for treating one of the major complications in sepsis by using a non-anticoagulant fraction of heparin called M6229 to neutralize toxic circulatory histones .Currently, the drug is in Phase I stage of its development for the treatment of sepsis. SNIPR 001: SNIPR Biome SNIPR001 is a novel, orally-administered antibiotic that is designed to precisely target difficult-to-treat bacterial infections. It is developed using SNIPR Biome's CRISPR-Guided VectorsT (CGVT Technology), which is designed to deliver CRISPR reagents into target bacterial cells. SNIPR001 is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome. It contains four CRISPR-armed phages that selectively target and eliminate E. coli strains that are resistant to fluoroquinolone, with demonstrated efficacy in animal disease models. Currently, the drug is in preclinical stage of its development for the treatment of sepsis. Sepsis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sepsis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs. Sepsis: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Sepsis Report Insights Sepsis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Sepsis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players SciClone Pharmaceuticals AdrenoMed AG Matisse Pharmaceuticals SNIPR Biome Tianjin Chase Sun Pharmaceutical Beijing Scitech-Mq Pharmaceuticals Recce Pharmaceuticals Inotrem Octapharma Shaperon Shionogi Pharmazz Seres Therapeutics Key Products Thymosin alpha 1 Enibarcimab M 6229 SNIPR 001 Kukoamine B ST-1830 RECCE 327 Nangibotide OctaplasLG HY209 Cefiderocol Centhaquine SER 155 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ixi7k5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Patient population benefitting most from enibarcimab treatment in septic shock can clearly be defined by two biomarkers, as shown by data presented todayIn the AdrenOSS-2 trial, the respective patient subgroup had a statistically significant >60% relative reduction in 28-day mortality vs. placebo. Adrenomed is preparing a confirmatory trialEnibarcimab is targeting loss of vascular integrity, a previously unaddressed pathophysiological mechanism1Adrenomed presenting on individualized precision medicine treatment at the World Sepsis Day Event, Berlin, September 122 HENNIGSDORF, Germany and BERLIN, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Adrenomed AG, the vascular integrity company, today announced new findings on the biomarker-guided treatment of septic shock with enibarcimab. New data analyses of the phase II clinical trial AdrenOSS-2 validate the precision medicine approach applied by Adrenomed in the development of its non-neutralizing antibody enibarcimab for the treatment of septic shock. It shows that the patient population benefitting most from enibarcimab can clearly be identified by the biomarkers Adrenomedullin (ADM) with elevated levels, and low levels of circulating dipeptidyl peptidase 3 (cDPP3). During the 11th Weimar Sepsis Update3, the data were presented in a scientific talk4 given today by Prof. Matthijs Kox, Department of Intensive Care Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands, and in a poster presentation5 from the working group of critical care physician Prof. Peter Pickkers, Nijmegen. In preparation of a confirmatory clinical trial, the double-blind, randomized, placebo-controlled, biomarker-guided phase II trial AdrenOSS-2 (n = 301) included a prespecified analysis of the role of cDPP3 as a second biomarker (next to ADM) to exclude patients who are unlikely to respond to enibarcimab treatment. DPP3 is a cytosolic enzyme involved in the degradation of various cardiovascular and endorphin mediators. High levels of circulating DPP3 (cDPP3) indicate a high risk of organ dysfunction and mortality.6 This pathway is mechanistically independent from the loss of vascular integrity, which is known to be the main driver of mortality in septic shock and is indicated by elevated plasma levels of ADM (>70 pg/mL). Consequently, the aim of additional analyses was to investigate the impact of different cDPP3 levels on the treatment effect (28-day all-cause mortality) and to identify a suitable cut-off level. It was shown that the effect of enibarcimab on mortality improves with lower cDPP3 values and that the patients with elevated ADM, but non-elevated baseline cDPP3 (below the upper normal range, ≤ 30-50 ng/mL), benefitted the most from enibarcimab treatment.7 At 28 days, this patient subgroup had a statistically significant >60% relative reduction in mortality compared to placebo.8 Adrenomed’s CMO Dr. Stephan Witte commented: “We are very pleased with these findings. They underpin Adrenomed’s hypothesis that there is an interplay between baseline DPP3 levels and treatment effects of enibarcimab in patients with septic shock. After many failures with other potential treatments in development, the use of biomarkers for the identification of patients most likely to respond to treatment is the appropriate way towards an effective treatment. It is therefore a great confirmation of Adrenomed’s efforts to bring precision medicine – which has been long established in other disease areas like oncology – also to intensive care units to reduce patient heterogeneity and develop effective treatments.” Dr. Richard Jones, CEO of Adrenomed, added: “These compelling clinical data results, presented at this very important sepsis congress strongly enhance our belief that enibarcimab can make a real difference to saving or improving the lives of the many patients suffering from septic shock. The AdrenOSS-2 trial has marked an important step forward in bringing our precision medicine approach to patients. Adrenomed is now using these findings for the confirmatory development trial and subsequent marketing authorization of enibarcimab.” Adrenomed’s participation in further meetings: In addition to the Sepsis Update meeting in Weimar Adrenomed’s representatives can be met at the following events: (1) Dr. Joachim Struck, Head of Research & Development, Adrenomed AG, will talk about ”Precision Medicine in New Therapies for Septic Shock” at the World Sepsis Day Event which will be held on September 12, 2023, in Berlin and virtually.9 (2) David Germonpré, Chief Financial Officer of Adrenomed, will attend the 23rd Annual Biotech in Europe Forum (Sachs Conference) on September 20-21, 2023, in Basel, Switzerland. About AdrenomedAdrenomed AG is a German privately financed, clinical-stage biopharmaceutical company. Adrenomed’s mission is to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options. Founded in 2009 by a management team with decades of in-depth experience in sepsis and deep knowledge in diagnostics and drug development, the company’s lead product candidate enibarcimab (formerly adrecizumab) is a first-in-class non-blocking monoclonal antibody. Enibarcimab targets the vasoprotective peptide Adrenomedullin, an essential regulator of vascular integrity. Enibarcimab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock. For further information, please visit www.adrenomed.com and follow us on LinkedIn and Twitter. Contact Adrenomed AGMartina Kalle-Brune, Ph.D.phone: +49 (0)3302 207780bd@adrenomed.com Media Inquiries MC Services AGEva Bauer / Julia von Hummelphone: +49 (0)89 2102280adrenomed@mc-services.eu _________________ References: 1 Precision medicine focuses on the identification of therapeutic strategies that are effective for a group of patients based on similar unifying characteristics. Shah FA et al. Am J Respir Crit Care Med. 2021 Oct 15;204(8):891-901.2 World Sepsis Day Event 2023, Sept. 12, 2023, 18:00 h: “Precision medicine in new therapies for septic shock”, Joachim Struck, Adrenomed, Germany.3 11th Weimar Sepsis Update of the German Sepsis Society (GSS), Weimar (Germany), Sept. 6-8, 2023.4 11th Weimar Sepsis Update, Session 10 Immunmodulation – advances and adaptions 3, Lecture “Non-neutralizing adrenomedullin antibody”, Matthijs Kox, Nijmegen, Netherlands.5 11th Weimar Sepsis Update, Poster Session 2: Clinical Sepsis / COVID-19 Research – Therapy, Poster “Biomarker-guided treatment of septic shock with enibarcimab – cut-off selection to overcome patient heterogenicity”.6 https://doi.org/10.1186/s13054-021-03471-2.7 https://doi.org/10.3389/fmed.2022.1058235.8 Van Lier D., Knothe C., Struck J., Witte S., Pickkers P. “Biomarker-guided treatment of septic shock with enibarcimab – cut-off selection to overcome patient heterogenicity”, 11th Weimar Sepsis Update, Poster Session 2023.9 WSD Event 2023 — World Sepsis Day – September 13 (attendance is free of charge, sign-up here).

Acute kidney injury (AKI) is a complex syndrome, which results in a rapid loss of kidney function, affecting 1 in 5 patients (1) during hospitalization. Four units at the University Hospital Heidelberg and Heidelberg Kidney Center implement Proenkephalin (penKid) in a pilot biomarker-based treatment approach to diagnose AKI faster and monitor it more accurately across departments. PenKid is a proposed biomarker for real-time kidney function that potentially closes on the gaps of the standard diagnostic procedures. HENNIGSDORF, GERMANY / ACCESSWIRE / August 26, 2022 / The diagnostic company SphingoTec GmbH (SphingoTec) announces the introduction of novel biomarker penKid in the clinical routine management of patients on a test basis in a total of four units at the University Hospital Heidelberg (UKHD) and Heidelberg Kidney Center (NZH). This includes the normal, the intermediate care (IMC), the nephrology, and the intensive care units (ICU) of both clinics in Heidelberg. According to recent data, the new diagnostic tool provides a faster and more accurate assessment of kidney function than current practice and aims to improve the management of patients with AKI. The condition is associated with high morbidity and mortality, and is a frequent complication of severe diseases, such as sepsis. The pilot implementation of penKid was started in cooperation with the Clinic for Anesthesiology at UKHD and the NZH with the long-term goal of improving the monitoring of patient's kidney function. This routine use of penKid on a centralized level in the hospital drives innovation on multiple wards such as nephrology, ICU and IMC. The biomarker will be used on top of standard of care, in order to compare penKid with the existing standard diagnostics. Better and faster information assessment of kidney function helps detect AKI earlier, so that prompt action can be taken to protect renal function and improve patient prognosis. Prof. Dr. med. Martin Zeier, Medical Director at NZH added, "After the first experience of penKid on the point of care analyzer from SphingoTec, we have decided to implement it in the central laboratory to apply the test in more patients at the same time. The goal is to investigate the added value compared to established renal function parameters in routine diagnostics. To date, our data suggest better and more direct information about kidney function, which may allow for more rapid action. Acute kidney injury is a serious condition that needs to be detected early and counteracted promptly. When the critically ill patients are undergoing renal replacement therapy, the decision to terminate the treatment is of high importance for the success of the therapy. With penKid we may achieve better insights that complement our current practices, and we have strong hopes that this will help us improve patient outcomes on short and long term." PenKid is a promising biomarker to determine kidney function. It has been studied in over 55,000 patients showing the potential to reflect kidney function in real-time (2,3). Data from the PredARRT-Sep-Trial enrolling patients hospitalized in the surgical ICU of UKHD showed that penKid is a kidney function biomarker with rapid kinetics. According to these findings shared with the scientific community during the AKI&CRRT 2021 conference in San Diego US (4), penKid especially indicates changes in kidney function more dynamically than established functional markers. For those patients in critical conditions who require dialysis, penKid seems to be an early indicator of the kidney function and a potential tool to monitor kidney function and recovery during dialysis. Prof. Dr. med. Markus Weigand, Medical Director of the Clinic for Anesthesiology at UKHD commented "On the ICU we experience the extreme of human disease, and AKI remains a serious complication in critically ill patients. A biomarker alerting changes in the kidney function faster than the currently known standards and uninfluenced by inflammation, has a significant potential for improving patient management. The sooner we identify a patient with kidney dysfunction, the faster we can intervene with life-saving procedures." Dr. Andreas Bergmann, founder and CSO of SphingoTec added "Testing penKid in routine practice at University Hospital Heidelberg brings the scientific advancements directly to those needing them the most: the patients. AKI is usually diagnosed after symptoms manifest, with diagnostic tests that have limited ability to identify early the onset of the disease. The blind spots in diagnosing kidney dysfunction are well known to the medical community, therefore penKid is a functional biomarker that addresses a clear unmet need and provides actionable information on all stages of the disease evolution." References: Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2. PMID: 22473149; PMCID: PMC3362180. Beunders R et al. Proenkephalin Compared to Conventional Methods to Assess Kidney Function in Critically Ill Sepsis Patients. Shock. 2020;54(3):308-14. Donato LJ et al. Analytical performance of an immunoassay to measure proenkephalin. Clin Biochem. 2018;58:72-7 About SphingoTec SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec's proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec's subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care. Media contact: Ulrike Glaubitz Sr. Public relations specialist SphingoTec GmbH Neuendorfstr. 15 A 16761 Hennigsdorf Tel. +49-3302-20565-0 press@sphingotec.com SOURCE: SphingoTec GmbH View source version on accesswire.com: