AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
AdrenoMed AG, the vascular integrity company, today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate enibarcimab, a first-in-class non-neutralizing monoclonal antibody, for the treatment of septic shock. AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.
Enibarcimab is a non-blocking antibody binding to the vasoprotective hormone adrenomedullin. Applying AdrenoMed’s precision medicine approach, enibarcimab treatment of patients with septic shock resulted in improved organ dysfunction and a relevant reduction of day 28 all-cause mortality from 24% to 8% in the patient population defined by the two biomarkers adrenomedullin and DPP3 in the AdrenOSS-2 trial.
With a mortality rate of 20-30% for sepsis1 and 30%-50% for septic shock in developed countries, sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths worldwide.
Fast Track is a process designed by the FDA to facilitate the development of promising drugs for the treatment of serious conditions that fill an unmet medical need and to accelerate review by the regulatory authority, aimed at getting important new drugs to the patient earlier. A drug that receives Fast Track designation is eligible for more frequent meetings with FDA to discuss development plans for the drug regarding collection of data needed to support its approval; more frequent communication about such things as the design of the proposed clinical trials and use of biomarkers; eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and Rolling Review.
Dr. Stephan Witte, CMO of AdrenoMed, said: “We are very confident that the use of enibarcimab in combination with two biomarkers, Adrenomedullin (bio-ADM) and circulating dipeptidyl peptidase 3 (cDPP3), holds the promise to become the first effective targeted treatment against septic shock. With AdrenoMed’s biomarker-guided approach it is possible to clearly define the patient population benefitting most from enibarcimab, resulting in a more pronounced treatment effect and leading to improved mortality in septic shock.”
April 12, 2024
