Adrenomed

Adrenomed AG is a privately financed, clinical-stage biopharmaceutical company operating from Hennigsdorf, Germany, with a focus on rescuing vascular integrity to save the lives of critically ill patients. The company was founded in 2009 by a team that includes Andreas Bergmann, Bernd Wegener, and Gerald Moeller, who brought decades of experience in sepsis, diagnostics, and drug development. Andreas Bergmann, a serial biotech entrepreneur, has a substantial background in developing blood-based diagnostic methods and was instrumental in developing the sepsis marker Procalcitonin (PCT®) at B.R.A.H.M.S. AG, a company he co-founded. This deep expertise in diagnostics and critical care underpins Adrenomed's strategic direction.

The company's core business revolves around the development of its lead product candidate, Enibarcimab (formerly Adrecizumab). This first-in-class monoclonal antibody targets the vasoprotective peptide Adrenomedullin, which is an essential regulator of the vascular system. The business model is centered on advancing Enibarcimab through clinical trials to eventually secure regulatory approval and commercialization, addressing the significant unmet medical need in the septic shock market, where mortality rates remain high. Adrenomed has successfully raised significant capital to fund its operations, including a €24 million Series D round in 2018 and a €22.2 million Series E round in 2020, with backing from investors like Wellington Partners and HBM Healthcare Investments.

Adrenomed's primary asset, Enibarcimab, is designed to restore and maintain vascular integrity, which is compromised in conditions like septic shock, leading to organ failure. The antibody works by binding to Adrenomedullin, preventing vascular leakage and stabilizing circulation. A key feature of Adrenomed's approach is its use of precision medicine; the company employs a biomarker-guided strategy to identify patient populations most likely to benefit from the treatment. Specifically, it uses elevated Adrenomedullin (ADM) levels to identify at-risk patients and low levels of circulating dipeptidyl peptidase 3 (cDPP3) to select those most likely to respond favorably. The Phase II AdrenOSS-2 trial, involving 301 patients with septic shock, demonstrated a favorable safety profile and significant improvement in organ function. In a specific biomarker-defined subgroup, Enibarcimab showed a statistically significant reduction in 28-day mortality. These promising results led to the U.S. FDA granting Fast Track designation for Enibarcimab in April 2024, facilitating its development path toward a confirmatory pivotal trial.

Keywords: septic shock, vascular integrity, monoclonal antibody, Enibarcimab, Adrenomedullin, precision medicine, critical care, biopharmaceutical, clinical-stage, biomarker-guided