4TEEN4 Pharmaceuticals has dosed the first patient in a phase 1b/2a trial of procizumab, a monoclonal antibody designed to treat cardiogenic shock by neutralising a key biological driver of the condition.
The multicentre PROCARD1 trial will assess safety, dosing and early signs of efficacy in up to 70 patients with elevated levels of circulating dipeptidyl peptidase 3 (cDPP3), a cardiac depression factor linked to poor outcomes in shock.
Procizumab works by inhibiting cDPP3, which degrades angiotensin II and disrupts the renin-angiotensin-aldosterone system. This dysregulation leads to cardiovascular collapse, organ failure and death. Preclinical studies showed procizumab restored cardiovascular function and improved survival.
Dr Andreas Bergmann, CEO of 4TEEN4 Pharmaceuticals said: “The initiation of this study marks a major milestone for 4TEEN4 as we advance our monoclonal antibody into later-stage clinical trials. Procizumab has already demonstrated the ability to reverse shock in both pre-clinical models and first clinical use, underscoring its therapeutic potential.”
Alexandre Mebazaa, Principal Investigator for the PROCARD1 study said: “Extensive research across more than 100,000 critically ill patients established that high levels of cDPP3 significantly indicate short-term mortality in shock patients. Procizumab is designed to intervene by neutralizing the negative effect of cDPP3.”
Patients will receive a single intravenous dose of either 10 mg/kg or 20 mg/kg of procizumab, or placebo, alongside standard care. Sites are located in Belgium, the Czech Republic, France, the Netherlands and Poland.
Cardiogenic shock is the second most common form of circulatory failure and remains a major unmet medical need. Mortality rates exceed 50% and no approved therapies currently target its underlying biological mechanisms.
