AdrenoMed Receives FDA Fast Track Designation for Enibarcimab in Septic Shock Treatment

AdrenoMed AG, a biopharmaceutical company, has announced that its lead product candidate, enibarcimab, received Fast Track designation from the US FDA for treating septic shock. Enibarcimab, a first-in-class non-neutralizing monoclonal antibody, aims to address the underlying pathophysiology of sepsis, which causes 20-30% mortality in sepsis and 30-50% in septic shock in developed countries. This designation accelerates the drug development and review processes for conditions with significant unmet medical needs.

In the AdrenOSS-2 Phase II trial, enibarcimab showed a significant >60% relative reduction in 28-day mortality vs. placebo for a specific patient subgroup. AdrenoMed plans to confirm these results in a forthcoming confirmatory Phase IIb/III clinical trial using a precision medicine approach. The treatment targets the vasoprotective hormone, adrenomedullin, showing promising improvements in organ dysfunction and a noteworthy reduction in all-cause mortality.

AdrenoMed's CEO, Dr. Richard Jones, expressed satisfaction with the FDA's recognition, highlighting the potential of enibarcimab to fulfill the unmet medical need in treating septic shock. The Fast Track designation allows for more frequent FDA interactions and a potential for Accelerated Approval and Priority Review. Dr. Stephan Witte, CMO of AdrenoMed, emphasized the effectiveness of the biomarker-guided treatment strategy, which could lead to significant improvements in mortality rates for patients with septic shock.