• Adrecizumab

    Adrecizumab

    First-in-class sepsis therapy
    The humanized monoclonal anti-ADM antibody modulates Adrenomedullin
    activity and improves all relevant end points in preclinical sepsis models

Adrecizumab

Clinical Stage First-in-Class Drug Candidate

Adrecizumab is a humanized murine monoclonal IgG1 antibody specifically binding the N-terminal region of human Adrenomedullin. It will be a first-in-class drug that targets and balances an essential mediator of septic shock.

  • High Preclinical Efficacy: In several resuscitated animal models of septic shock (mouse, rat, pig), Adrecizumab has shown to improve all clinically relevant end points. It reduces vascular leakage, stabilizes the circulation, by restoring blood pressure, normalizing fluid balance and reducing vasopressor demand, improves renal function and reduces mortality from septic shock by 50% (For further details see below or our publication list).
  • Industry standard GMP Material available: After completion of the preclinical proof-of-concept phase, the development entered the regulatory phase by initiating the CMC (Chemistry, Manufacturing and Controls) section. Meanwhile, the Good Manufacturing Practice (GMP) process is established and sufficient GMP material for Clinical Phases I and II is available.
  • Strong Patent Position: Adrenomed AG owns six patent families, two already issued in an EP and US patent, that effectively secures our business.
  • Excellent Tox & Safety Results: Regulatory (GLP) Toxicology & Safety studies in healthy rodents (rats) and non-rodents (dogs and non-human primates) showed that Adrecizumab is well tolerated and has an excelllent safety profile.
  • Phase I: Safety & Tolerability in healthy subjects (Status: last patient out)
  • Phase II Goal: Demonstrate Safety & Tolerability, Dose Finding & Effect Size Estimation for Phase III

 

  Preclinical results

Adrecizumab has shown to improve all clinically relevant end points in several resuscitated animal models of septic shock (mouse, rat, pig). It reduces vascular leakage, stabilizes the circulation, by restoring blood pressure and reducing vasopressor demand, improves renal function and reduces mortality from septic shock by 50%

Adrecizumab restores blood pressure

Blood pressure [in mmHg] of healthy rats (Healthy) and of rats after sepsis induction (CLP - cecal ligation and puncture - model), either treated with Adrecizumab or an unspecific control antibody (control). Adapted from Blet et al. Intensive Care Med Exp 2015, 3(Suppl 1):A618.

Fig 1 Preclinical bloodpressure 

Adrecizumab improves survival by 50%

Survival rate of rats after sepsis induction (CLP - cecal ligation and puncture - model), either treated with Adrecizumab or an unspecific control antibody. Adapted from Struck et al. Intensive Care Medicine Experimental 2013, 1:3.

 

 

 

 

 

 

 

 

 

For further results and details please see our publication list.