4TEEN4 Doses First Patient in Phase 1b/2a Trial of Procizumab, a Monoclonal Antibody Targeting the Biological Driver of Shock

• The trial will evaluate safety, dosing, and efficacy in patients with cardiogenic shock
  
  

Hennigsdorf/ Berlin, July 23, 2025 – 4TEEN4 Pharmaceuticals GmbH today announced that the first patient has been dosed in a Phase 1b/2a PROCARD1 clinical trial evaluating its monoclonal antibody, procizumab, in patients with shock caused primarily by cardiogenic events. Shock is a life-threatening condition characterized by a sudden breakdown in circulatory function due to end-stage disease or acute events, which often leads to organ failure. With only symptomatic treatment options available, shock is associated with a high mortality rate of over 50%. The Phase 1b/2a trial is designed to identify a target dose for procizumab in preparation for further clinical development. In addition, the trial will provide signals of efficacy. In a Phase 1 study in healthy volunteers, procizumab was well tolerated.

Procizumab is a monoclonal antibody that neutralizes circulating dipeptidyl peptidase 3 (cDPP3), a cardiac depression factor and key pathological driver in shock. Circulating DPP3 degrades angiotensin II, inducing a loss of control over the renin-angiotensin-aldosterone system (RAAS). This dysregulation leads to cardiovascular collapse, marked by organ failure and ultimately, death. In preclinical studies, procizumab has been shown to inhibit cDPP3 activity, resulting in restored control over the RAAS system, normalized cardiovascular function, and improved survival.

“The initiation of this study marks a major milestone for 4TEEN4 as we advance our monoclonal antibody into later-stage clinical trials,” stated Dr. Andreas Bergmann, CEO of 4TEEN4 Pharmaceuticals. “Procizumab has already demonstrated the ability to reverse shock in both pre-clinical models and first clinical use, underscoring its therapeutic potential.”

“Extensive research across more than 100,000 critically ill patients established that high levels of cDPP3 significantly indicate short-term mortality in shock patients,” commented Alexandre Mebazaa, MD, PhD, Professor of Medicine at Université Paris Cité in France and Principal Investigator for the PROCARD1 study. “In many patients, shock progresses rapidly after cDPP3 levels exceed the normal threshold, at which point the likelihood of recovery declines dramatically. Procizumab is designed to intervene by neutralizing the negative effect of cDPP3. This mechanistic approach could enable a significant reduction in mortality by intervening at the biological root of shock, rather than its downstream effects.”

PROCARD1 (NCT06832722) is a multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a trial assessing the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of procizumab in patients with cardiogenic shock and elevated cDPP3 levels. Up to 70 patients will be enrolled across 11 centers in Belgium, the Czech Republic, France, the Netherlands, and Poland. Patients will receive a single intravenous dose of either procizumab at 10 mg/kg, 20 mg/kg, or placebo, alongside standard of care.

About Shock
Shock is a severe and life-threatening condition in which the circulatory system fails to deliver sufficient oxygen to meet the body’s metabolic demands, leading to organ dysfunction and high mortality. It can result from a variety of causes, including sepsis, trauma, burns, major surgery, and cardiac events, and accounts for approximately one in three admissions to intensive care units (ICUs).¹

Cardiogenic shock is the second most common form of circulatory failure. It is most often triggered by acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF). Despite advances in supportive care, cardiogenic shock remains a major unmet medical need, with no approved therapies that target its underlying causes and mortality rates exceeding 50%²³.

About Procizumab
Procizumab is a humanized monoclonal antibody designed to selectively target circulating dipeptidyl peptidase 3 (cDPP3). Under physiological conditions, DPP3 is an intracellular enzyme. However, when released into the circulation, typically as a result of cellular injury, it degrades angiotensin peptides, resulting in dysregulation of the renin-angiotensin-aldosterone system (RAAS). The loss of RAAS control can lead to shock, broad organ failure, and ultimately death. By inhibiting cDPP3 activity, procizumab restores RAAS balance and stabilizes cardiovascular function. The therapeutic potential of procizumab has been demonstrated in pre-clinical and clinical settings, where it effectively normalized cardiovascular parameters, reversed organ dysfunction, and increased survival. Procizumab also exhibited a favorable safety and tolerability profile in a completed Phase 1 study in healthy volunteers.

About 4TEEN4
4TEEN4’s mission is to reverse life-threatening shock and restore organ function with procizumab. This highly specific, first-in-class antibody blocks circulating DPP3, the key pathological driver of mortality in shock. Based on highly encouraging results across preclinical models and initial use in patients, procizumab is now in a Phase 1b/2a study evaluating its potential as a treatment for shock caused by acute cardiovascular and septic events. By targeting the root cause, 4TEEN4 aims to move shock treatment beyond supportive care and improve survival in critically ill patients.

Investor & Media Contact:
Trophic Communications
Eva Mulder & Charlotte Spitz, PhD
+49 171 3512733
4TEEN4@trophic.eu

¹ Van Lier, D. & Pickkers, P. Circulating biomarkers to assess cardiovascular function in critically ill. Curr. Opin. Crit. Care 27, 261–268 (2021).
² an Diepen, S. et al. Contemporary Management of Cardiogenic Shock: A Scientific Statement from the American Heart Association. Circulation vol. 136 (2017)
³ Arrigo, M. et al. Current and future trial design in refractory cardiogenic shock. Eur. J. Heart Fail. 25, 609–615 (2023)

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