The biomarker-guided, randomized, double-blind, placebo-controlled, multicenter proof-of-concept AdrenOSS-II trial is evaluating the safety, tolerability and efficacy of Adrecizumab in 300 patients with early septic shock and elevated blood levels of the vasoprotective peptide Adrenomedullin (bio-ADM®). The primary endpoints are safety and tolerability of Adrecizumab over a 90-day period. A key secondary endpoint is the Sepsis Support Index (SSI) defined as days with organ support or death within 14 days. The AdrenOSS-II trial started in December 2017 and is currently running in about 30 centers throughout Germany, Belgium, France and the Netherlands (NCT03085758). To date, over 145 patients have been enrolled. Full details of the Phase II trial design have now been published on BMJ Open.
Adrenomed’s first-in-class antibody Adrecizumab specifically targets Adrenomedullin, an essential regulator of vascular integrity to treat life-threatening conditions associated with increased vascular leakage, congestion and shock. Adrenomedullin (bio-ADM®) was validated as critical biomarker and target in the AdrenOSS-I study, which demonstrated a correlation between high plasma levels of bio-ADM® and organ dysfunction as well as higher mortality rates in patients with sepsis and septic shock (NCT02393781). The full article was recently published in Critical Care. Adrecizumab demonstrated an excellent safety profile in two Phase I trials (NCT02991508, NCT03083171, British Journal of Clinical Pharmacology).