Adrenomed AG, the vascular integrity company, has announced that its proprietary sepsis drug candidate Adrecizumab (HAM8101) received a funding commitment of € 7.4 million from the German Federal Ministry of Education and Research (BMBF) as part of the German funding initiatives for the clinical development of COVID-19 drugs and their manufacturing capabilities.
The University Medical Center Eppendorf (UKE) Hamburg and Adrenomed will receive funds to conduct an investigator initiated Phase II clinical trial with Adrecizumab in hospitalized patients with moderate to severe COVID-19, which has received regulatory approval by the German federal agency, Paul Ehrlich Institute (PEI). Additionally, the BMBF will support financially the manufacturing of GMP Phase III clinical trial material, the company said.
Adrecizumab, a first-in-class antibody targeting the vasoprotective peptide adrenomedullin, is currently being developed for the treatment of loss of vascular integrity in sepsis and septic shock. Dysregulation of the endothelial barrier appears to be a common feature of COVID-19 patients and sepsis or septic shock patients. The deteriorated endothelial barrier function leads to vascular leakage and severe impairment of lung and other organ functions. In a novel precision medicine approach, patients with elevated adrenomedullin levels will be treated with Adrecizumab to restore and maintain the endothelial barrier and to avoid further organ dysfunction. At the same time, another biomarker (dipeptidyl peptidase-3, DPP3) is used to exclude patients with an additional competing pathophysiology. The UKE has initiated a national, multicenter, biomarker-guided, placebo-controlled Phase II trial to evaluate the efficacy of Adrecizumab plus standard of care (SOC) and plans to enroll more than 200 patients with moderate to severe COVID-19 and elevated adrenomedullin levels, the company explained.
Prof. Dr. med. Stefan Kluge, Director of the Department of Intensive Care Medicine at UKE, said: “We urgently need effective drugs for the treatment of hospitalized COVID-19 patients. Particularly important are therapies that can be used in severe cases and can be given at later disease stages. Adrecizumab could potentially be a therapy that can address this treatment gap. In a previous named-patient program with critically ill COVID-19 patients treated with Adrecizumab, we have already observed a rapid improvement in organ function. Based on these results and the positive signals from the AdrenOSS-2 study in septic shock, we will now evaluate a precision medicine approach with Adrecizumab to treat COVID-19 patients with deteriorating endothelial function and increased risk of organ failure and mortality.”
“With Adrecizumab we provide a treatment option that aims at restoring and maintaining the impaired vascular integrity in COVID-19 other than antiviral drugs”, Dr. Jens Zimmermann, Chief Medical Officer at Adrenomed added. “This approach may help to improve the organ function and thus survival rates of hospitalized COVID-19 patients. We are very grateful for this financial support granted by the BMBF which enables Adrenomed to pursue the clinical development of Adrecizumab in the treatment of COVID-19, as well as the manufacturing process.”
Dr. Richard Jones, Chief Executive Officer of Adrenomed, stated: “This funding commitment of € 7.4 million from the BMBF is a significant endorsement of Adrenomed’s innovative bio-marker guided precision medicine approach for patients in the acute care setting. This clinical study further compliments our overall development program of Adrecizumab for the treatment of loss of vascular integrity in sepsis and septic shock in collaboration with our strategic partner, Sphingotec.”