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- || Review, Journal, PD(L)-1 Biomarker, IO biomarker: Recent advances of precision immunotherapy in sepsis. (Pubmed Central) - Feb 26, 2025
Biomarkers that guide their use are the expression of the human leukocyte antigen DR on blood monocytes, the absolute lymphocyte count and blood levels of immunoglobulin M. One recently suggested strategy to restore vascular tone is adrecizumab, the use of which is guided by blood levels of bio-adrenomedulin. The use of these precision treatment strategies is still hampered by the need for large-scale randomized controlled trials.
- | enibarcimab (HAM8101) / Adrenomed
Journal: High circulating dipeptidyl peptidase 3 predicts mortality and need for organ support in cardiogenic shock: An ancillary analysis of the ACCOST-HH trial. (Pubmed Central) - Jan 16, 2025
The use of these precision treatment strategies is still hampered by the need for large-scale randomized controlled trials. The present study confirms the prognostic value of cDPP3 in a contemporary population of patients with CS.
- || enibarcimab (HAM8101) / Adrenomed
P2 data, Journal: The ADESTE trial: A phase 2 study of enibarcimab, a monoclonal antibody targeting adrenomedullin, in acute heart failure. (Pubmed Central) - Jan 15, 2025
The present study confirms the prognostic value of cDPP3 in a contemporary population of patients with CS. In this pilot safety study of patients hospitalized for AHF, IV infusion of EN 0.5 and 2
- enibarcimab (HAM8101) / Adrenomed
Precision medicine in septic shock with enibarcimab () - Mar 18, 2024 - Abstract #ISICEM2024ISICEM_1178;
In this pilot safety study of patients hospitalized for AHF, IV infusion of EN 0.5 and 2 These previously unpublished data from the AdrenOSS -2 trial show that a precision medicine approach using bio-ADM and cDPP3 for patient selection can overcome patient heterogeneity in septic shock leading to improved mortality.
- enibarcimab (HAM8101) / Adrenomed
Elevated dipeptidyl peptidase 3 predicts morbidity and mortality in cardiogenic shock: pre-specified secondary analyses from the accost-hh trial () - Mar 18, 2024 - Abstract #ISICEM2024ISICEM_1051;
Circulating DPP3 is a strong predictor of morbidity and mortality in cardiogenic shock. The results need to be validated in further cardiogenic shock cohorts, but otherwise hold strong promise for the upcoming clinical trials on the evaluation of the specific DPP3 -antibody Procizumab as new breakthrough therapy in cardiogenic shock.
- | enibarcimab (HAM8101) / Adrenomed
Biomarker, Enrollment change, Trial termination: AGNES-19: Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (clinicaltrials.gov) - Jan 2, 2024
P2, N=16, Terminated, Sponsor: Universit
The results need to be validated in further cardiogenic shock cohorts, but otherwise hold strong promise for the upcoming clinical trials on the evaluation of the specific DPP3 -antibody Procizumab as new breakthrough therapy in cardiogenic shock. N=180 --> 16 | Recruiting --> Terminated; Due to poor recruitment.
- || enibarcimab (HAM 8101) / Adrenomed
P2 data, Retrospective data, Journal: Effects of enrichment strategies on outcome of adrecizumab treatment in septic shock: Post-hoc analyses of the phase II adrenomedullin and outcome in septic shock 2 trial. (Pubmed Central) - Dec 20, 2022
In contrast, treatment timing was not significantly associated with 28-day mortality in multivariate interaction analyses. In septic shock patients with high ADM levels, a further post-hoc enrichment strategy based on cDPP3 may indicate (with all the caveats to be considered for post-hoc subgroup analyses) that therapeutic efficacy is most pronounced in patients with lower cDPP3 levels.
- | enibarcimab (HAM8101) / Adrenomed
Biomarker, Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: AGNES-19: Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (clinicaltrials.gov) - Oct 13, 2022
P2, N=180, Recruiting, Sponsor: Universit
In septic shock patients with high ADM levels, a further post-hoc enrichment strategy based on cDPP3 may indicate (with all the caveats to be considered for post-hoc subgroup analyses) that therapeutic efficacy is most pronounced in patients with lower cDPP3 levels. Not yet recruiting --> Recruiting | Trial completion date: Sep 2023 --> Dec 2023 | Initiation date: Jul 2022 --> Oct 2022 | Trial primary completion date: Mar 2023 --> Sep 2023
- | enibarcimab (HAM8101) / Adrenomed
Biomarker, Trial completion date, Trial initiation date, Trial primary completion date: AGNES-19: Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (clinicaltrials.gov) - Jul 1, 2022
P2, N=180, Not yet recruiting, Sponsor: Universit
Not yet recruiting --> Recruiting | Trial completion date: Sep 2023 --> Dec 2023 | Initiation date: Jul 2022 --> Oct 2022 | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: Jun 2023 --> Sep 2023 | Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Dec 2022 --> Mar 2023
- || enibarcimab (HAM 8101) / Adrenomed
Clinical, Journal: Single-dose of adrecizumab versus placebo in acute cardiogenic shock (ACCOST-HH): an investigator-initiated, randomised, double-blinded, placebo-controlled, multicentre trial. (Pubmed Central) - Mar 23, 2022
P2/3
Trial completion date: Jun 2023 --> Sep 2023 | Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Dec 2022 --> Mar 2023 Adrecizumab was well tolerated in patients with cardiogenic shock but did not reduce the need for cardiovascular organ support or improve survival at days 30 and 90.
- | enibarcimab (HAM 8101) / Adrenomed
Journal: International clinical research of critical care medicine in 2021 (Pubmed Central) - Mar 23, 2022
However, we also encounter negative results such as balanced solution during fluid resuscitation, hypothermia therapy after out-of-hospital cardiac arrest or traumatic brain injury, adrenomedullin-specific antibody adrecizumab therapy and coupled plasma filtration-adsorption (CPFA) therapy for patients with septic shock, extracorporeal carbon dioxide removal (ECCOR) implementation in acute hypoxic respiratory failure, continuous infusion of hypertonic saline in patients with traumatic brain injury. Collectively, in the future, individualized diagnosis and management based on the principle of "wise choice" will become the daily practice scene for all intensivists.
- enibarcimab (HAM 8101) / Adrenomed
Adrecizumab? (Copper Hall) - Mar 18, 2022 - Abstract #ISICEM2022ISICEM_764;
- | enibarcimab (HAM8101) / Adrenomed
Biomarker, Phase classification, Trial initiation date: AGNES-19: Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (clinicaltrials.gov) - Mar 16, 2022
P2, N=218, Not yet recruiting, Sponsor: Universit
Collectively, in the future, individualized diagnosis and management based on the principle of "wise choice" will become the daily practice scene for all intensivists. Phase classification: P2/3 --> P2 | Initiation date: Dec 2021 --> Mar 2022
- || enibarcimab (HAM 8101) / Adrenomed
Review, Journal: Translational studies of adrenomedullin and related peptides regarding cardiovascular diseases. (Pubmed Central) - Feb 26, 2022
Accordingly, these derivatives will reduce the inconvenience in use compared to that for native AM and expand the possible applications of AM for treating CVDs. In this review, we present the latest translational status of AM and its derivatives.
- | enibarcimab (HAM8101) / Adrenomed
Biomarker, New P2 trial, New P2/3 trial: AGNES-19: Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial (clinicaltrials.gov) - Dec 13, 2021
P2/3, N=218, Not yet recruiting, Sponsor: Universit
- || enibarcimab (HAM 8101) / Adrenomed
Biomarker, Clinical, P2a data, Journal: Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. (Pubmed Central) - Nov 17, 2021
Overall, we successfully completed a randomized trial evaluating selecting patients for enrolment who had a disease-related biomarker. There were no overt signals of harm with using two doses of the adrenomedullin antibody adrecizumab; however, further randomized controlled trials are required to confirm efficacy and safety of this agent in septic shock patients.
- | Journal: European Society of Cardiology (ESC) Congress 2021 (August 27-30, 2021 - Virtual Meeting). (Pubmed Central) - Nov 6, 2021
There were no overt signals of harm with using two doses of the adrenomedullin antibody adrecizumab; however, further randomized controlled trials are required to confirm efficacy and safety of this agent in septic shock patients. The 2021 Congress of the European Society of Cardiology (ESC) was again held as a digital experience, providing poster and oral sessions highlighting the latest developments in cardiovascular science, including therapeutics for a range of related conditions and updates on ongoing trials, as well as guideline updates.
- |||| enibarcimab (HAM 8101) / Adrenomed
Clinical: Could Adrecizumab be part of the answer to improve outcomes in cancer patients with septic shock? Adrenomedullin is known to be elevated in patients with GI and lung cancer as well as in Sepsis, the combination could be associated with worse outcomes. (Twitter) - Oct 16, 2021
- | enibarcimab (HAM 8101) / Adrenomed
Preclinical, Journal: Effects of the Non-Neutralizing Humanized Monoclonal Anti-Adrenomedullin Antibody Adrecizumab on Hemodynamic and Renal Injury in a Porcine Two-Hit Model. (Pubmed Central) - Oct 8, 2021
After induction of sepsis, plasma adrenomedullin increased immediately in both groups, but increased quicker and more pronounced in the antibody group.In this two hit shock model, treatment with an anti-adrenomedullin antibody significantly increased plasma adrenomedullin levels, while significantly less animals developed septic shock and renal granulocyte extravasation was significantly reduced. Thus, therapy with Adrecizumab may provide benefit in sepsis, and clinical investigation of this drug candidate is warranted.
- | enibarcimab (HAM8101) / Adrenomed
Trial completion, Trial completion date, Trial primary completion date: ACCOST-HH: Adrecizumab in Cardiogenic Shock (clinicaltrials.gov) - Oct 8, 2021
P2/3, N=150, Completed, Sponsor: Dr. med. Mahir Karakas
Thus, therapy with Adrecizumab may provide benefit in sepsis, and clinical investigation of this drug candidate is warranted. Recruiting --> Completed | Trial completion date: Jun 2020 --> Apr 2021 | Trial primary completion date: Mar 2020 --> Apr 2021
- enibarcimab (HAM 8101) / Adrenomed
[VIRTUAL] ACCOST-HH: Adrecizumab in cardiogenic shock (Channel 2) - Jul 6, 2021 - Abstract #ESC2021ESC_5365;
- | adrecizumab (HAM 8101) / Adrenomed
Journal: Significance of adrenomedullin and the role of adrecizumab in sepsis. (Pubmed Central) - Jul 1, 2021
Recruiting --> Completed | Trial completion date: Jun 2020 --> Apr 2021 | Trial primary completion date: Mar 2020 --> Apr 2021 No abstract available
- | enibarcimab (HAM8101) / Adrenomed
Trial completion date, Trial primary completion date: Adrecizumab Dose Escalation Safety and Tolerability Evaluation (ADESTE) (clinicaltrials.gov) - Mar 9, 2021
P2, N=30, Recruiting, Sponsor: GREAT Network Italy
No abstract available Trial completion date: Dec 2020 --> Mar 2022 | Trial primary completion date: Jun 2020 --> Dec 2021
- | adrecizumab (HAM 8101) / Adrenomed
Biomarker, Journal: Adrecizumab: an investigational agent for the biomarker-guided treatment of sepsis. (Pubmed Central) - Feb 18, 2021
P2
A positive pivotal phase III trial is indeed needed to convince the intensive care community to prescribe ADZ in septic shock patients. Further, it would be of interest to see whether ADZ might also benefit other critical diseases such as cardiogenic shock where endothelial dysfunction has also been described.
- || enibarcimab (HAM8101) / Adrenomed
Trial completion: Adrecizumab-LPS Study (clinicaltrials.gov) - Jan 31, 2021
P1, N=24, Completed, Sponsor: Adrenomed AG
Further, it would be of interest to see whether ADZ might also benefit other critical diseases such as cardiogenic shock where endothelial dysfunction has also been described. Active, not recruiting --> Completed
- || adrecizumab (HAM 8101) / Adrenomed
Clinical, Journal: Targeting Endothelial Dysfunction in Eight Extreme-Critically Ill Patients with COVID-19 Using the Anti-Adrenomedullin Antibody Adrecizumab (HAM8101). (Pubmed Central) - Sep 9, 2020
In conclusion, in this preliminary uncontrolled case series of eight shock patients with life-threatening COVID-19 and ARDS, the administration of Adrecizumab was followed by a favorable outcome. Although the non-controlled design and the small sample size preclude any definitive statement about the potential efficacy of Adrecizumab in critically ill COVID-19 patients, the results of this case series are encouraging.
- |||| enibarcimab (HAM8101) / Adrenomed
Trial completion: AdrenOSS-2: Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (clinicaltrials.gov) - Jun 24, 2020
P2, N=301, Completed, Sponsor: Adrenomed AG
Although the non-controlled design and the small sample size preclude any definitive statement about the potential efficacy of Adrecizumab in critically ill COVID-19 patients, the results of this case series are encouraging. Recruiting --> Completed
- | adrecizumab (HAM 8101) / Adrenomed
Journal: Preclinical safety evaluation of the adrenomedullin-binding antibody Adrecizumab in rodents, dogs and non-human primates. (Pubmed Central) - Apr 14, 2020
In conclusion, intravenous, repeated administration of high doses of Adrecizumab appeared well-tolerated across species. These results pave the way for further investigation of Adrecizumab in humans (intended dose of 2 mg/kg).
- || adrecizumab (HAM 8101) / Adrenomed
Biomarker, Clinical, P2 data, Journal: A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2). (Pubmed Central) - Feb 25, 2020
P2
Results of this study will be published in a peer-reviewed scientific journal. NCT03085758; Pre-results.
- | enibarcimab (HAM8101) / Adrenomed
New P2 trial: Adrecizumab Dose Escalation Safety and Tolerability Evaluation (ADESTE) (clinicaltrials.gov) - Feb 4, 2020
P2, N=30, Recruiting, Sponsor: GREAT Network Italy
- | adrecizumab (HAM 8101) / Adrenomed
Clinical, P1 data, PK/PD data, Journal: Safety, tolerability and pharmacokinetics/-dynamics of the adrenomedullin antibody Adrecizumab in a first-in-human study and during experimental human endotoxemia in healthy subjects. (Pubmed Central) - Oct 16, 2019
Administration of Adrecizumab is safe and well-tolerated in humans, both in the absence and presence of systemic inflammation. These findings pave the way for further investigation of Adrecizumab in sepsis patients.
- | adrecizumab (HAM 8101) / Adrenomed
Journal: Effects of the Humanized Anti-Adrenomedullin Antibody Adrecizumab (HAM8101) on Vascular Barrier Function and Survival in Rodent Models of Systemic Inflammation and Sepsis. (Pubmed Central) - Oct 9, 2019
These findings pave the way for further investigation of Adrecizumab in sepsis patients. Pretreatment with the humanized anti-ADM antibody HAM8101 improved vascular barrier function and survival in rodent models of systemic inflammation and sepsis.
- | adrecizumab (HAM 8101) / Adrenomed
Journal: Vascular Effects of Adrenomedullin and the Anti-Adrenomedullin Antibody Adrecizumab in Sepsis. (Pubmed Central) - Oct 2, 2019
In this review, we first provide a brief overview of the currently available data on the role of adrenomedullin in sepsis and describe its effects on endothelial barrier function and vasodilation. Furthermore, we provide a novel hypothesis concerning the mechanisms of action through which Adrecizumab may exert its beneficial effects in sepsis.
- | enibarcimab (HAM8101) / Adrenomed
Trial completion date: AdrenOSS-2: Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (clinicaltrials.gov) - Sep 30, 2019
P2, N=300, Recruiting, Sponsor: Adrenomed AG
Furthermore, we provide a novel hypothesis concerning the mechanisms of action through which Adrecizumab may exert its beneficial effects in sepsis. Trial completion date: Sep 2019 --> Dec 2019
- | enibarcimab (HAM8101) / Adrenomed
New P2/3 trial: ACCOST-HH: Adrecizumab in Cardiogenic Shock (clinicaltrials.gov) - Jun 18, 2019
P2/3, N=150, Recruiting, Sponsor: Dr. med. Mahir Karakas
- |||| enibarcimab (HAM8101) / Adrenomed
Enrollment open, Trial initiation date, Trial primary completion date: AdrenOSS-2: Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (clinicaltrials.gov) - Dec 21, 2017
P2, N=300, Recruiting, Sponsor: Adrenomed AG
Trial completion date: Sep 2019 --> Dec 2019 Not yet recruiting --> Recruiting | Initiation date: May 2017 --> Dec 2017 | Trial primary completion date: Dec 2018 --> Jul 2019
- ||||| enibarcimab (HAM8101) / Adrenomed
New P2 trial: AdrenOSS-2: Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB (clinicaltrials.gov) - Mar 21, 2017
P2, N=300, Not yet recruiting, Sponsor: Adrenomed AG
- | enibarcimab (HAM8101) / Adrenomed
New P1 trial: Adrecizumab-LPS Study (clinicaltrials.gov) - Mar 16, 2017
P1, N=24, Active, not recruiting, Sponsor: Adrenomed AG
- | enibarcimab (HAM8101) / Adrenomed
Trial completion: Adrecizumab Phase 1 Trial (clinicaltrials.gov) - Mar 14, 2017
P1, N=24, Completed, Sponsor: Radboud University
Not yet recruiting --> Recruiting | Initiation date: May 2017 --> Dec 2017 | Trial primary completion date: Dec 2018 --> Jul 2019 Active, not recruiting --> Completed