Enibarcimab Granted Fast Track Designation for Septic Shock

The Food and Drug Administration (FDA) has granted Fast Track designation to enibarcimab for the treatment of septic shock.

Enibarcimab (formerly adrecizumab) is a first-in-class non-neutralizing monoclonal antibody that binds to adrenomedullin (ADM), a vasoprotective hormone. It is believed that modulating the ADM pathway may improve outcomes in patients with septic shock.

The Fast Track designation was based on data from the AdrenOSS-2 phase 2a biomarker-guided trial (ClinicalTrials.gov Identifier: NCT03085758), which included 301 patients with early septic shock and a bio-ADM plasma concentration at admission of at least 70pg/mL. Study participants were randomly assigned to receive a single infusion of enibarcimab or placebo. 

Results showed enibarcimab was well tolerated with the frequency and severity of adverse events being similar between the groups. Further subgroup analysis indicated that 2 biomarkers, ADM and circulating dipeptidyl peptidase 3 (cDPP3), could help identify patients who would benefit most from enibarcimab therapy. Compared with the total study population, the effect of enibarcimab on mortality improved in patients with lower cDPP3 values (<50ng/mL). 

In the low cDPP3 subgroup, the incidence of 28-day mortality in the enibarcimab arm was 16% compared with 25% for placebo (hazard ratio, 0.61 [95% CI, 0.34-1.08]; P =.085). In the total population, the incidence of 28-day mortality was 23% in the enibarcimab group vs 28% in the placebo group (HR, 0.84 [95% CI, 0.53-1.31]; P =.439).

“We are very confident that the use of enibarcimab in combination with 2 biomarkers, bio-ADM and cDPP3, holds the promise to become the first effective targeted treatment against septic shock,” said Dr Stephan Witte, CMO of AdrenoMed. “With AdrenoMed’s biomarker-guided approach it is possible to clearly define the patient population benefiting most from enibarcimab, resulting in a more pronounced treatment effect and leading to improved mortality in septic shock.”

The Company is currently preparing for a phase 2b/3 trial to confirm the benefits of enibarcimab.