• The study will assess safety, dosage, and effectiveness in individuals experiencing cardiogenic shock.

Hennigsdorf/ Berlin, July 23, 2025 – announced today that the first participant has received a dose in the Phase 1b/2a PROCARD1 clinical trial. This trial is evaluating procizumab, their monoclonal antibody, in patients suffering from shock primarily caused by cardiogenic events. Shock is a critical condition where circulatory function suddenly fails due to severe illness or acute incidents, often resulting in organ failure. Current treatment options are limited to addressing symptoms, leading to a high mortality rate exceeding 50%. The Phase 1b/2a trial aims to determine an appropriate dose of procizumab for future clinical development. Additionally, the trial will offer indications of its efficacy. A previous Phase 1 study showed that procizumab was well tolerated by healthy volunteers.

Procizumab is a monoclonal antibody that works by neutralizing circulating dipeptidyl peptidase 3 (cDPP3), a factor that depresses cardiac function and is a key pathological driver in shock. Circulating DPP3 breaks down angiotensin II, causing a loss of control over the renin-angiotensin-aldosterone system (RAAS). This disruption results in cardiovascular collapse, characterized by organ failure and ultimately, death. Preclinical studies have demonstrated that procizumab inhibits cDPP3 activity, restoring control over the RAAS system, normalizing cardiovascular function, and improving survival rates.

“The start of this study is a significant achievement for 4TEEN4 as we move our monoclonal antibody forward into more advanced clinical trials,” said Dr. Andreas Bergmann, CEO of 4TEEN4 Pharmaceuticals. “Procizumab has already shown the ability to reverse shock in preclinical models and initial clinical use, highlighting its potential as a therapy.”

“Extensive research involving over 100,000 critically ill patients has established that elevated cDPP3 levels are a strong indicator of 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 once cDPP3 levels surpass the normal threshold, significantly reducing the chance of recovery. Procizumab is designed to counteract this by neutralizing the adverse effects of cDPP3. This mechanistic approach has the potential to significantly decrease mortality by addressing the underlying biological cause of shock, rather than just its downstream consequences.”

PROCARD1 is a multi-center, randomized, double-blind, placebo-controlled Phase 1b/2a trial evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of procizumab in patients with cardiogenic shock who also have elevated cDPP3 levels. The trial plans to enroll up to 70 patients across 11 centers in Belgium, the Czech Republic, France, the Netherlands, and Poland. Participants will receive a single intravenous dose of procizumab at either 10 mg/kg, 20 mg/kg, or a placebo, in addition to standard medical care.

About Shock
Shock is a critical and life-threatening condition where the circulatory system fails to deliver enough oxygen to meet the body’s metabolic needs, leading to organ dysfunction and high mortality rates. It can be caused by various factors, including sepsis, trauma, burns, major surgery, and cardiac events, and accounts for approximately one-third of admissions to intensive care units (ICUs).1

Cardiogenic shock is the second most prevalent type of circulatory failure, often triggered by acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF). Despite improvements in supportive care, cardiogenic shock remains a significant unmet medical need, as there are no approved treatments that target its fundamental causes, and mortality rates remain above 50%.23.

About Procizumab
Procizumab is a humanized monoclonal antibody specifically designed to target circulating dipeptidyl peptidase 3 (cDPP3). Under normal conditions, DPP3 is an enzyme located inside cells. However, when it is released into the bloodstream, typically due to cellular damage, it breaks down angiotensin peptides, leading to dysregulation of the renin-angiotensin-aldosterone system (RAAS). This loss of RAAS control can result in shock, widespread 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 preclinical and clinical settings, where it effectively normalized cardiovascular parameters, reversed organ dysfunction, and increased survival rates. Procizumab has also shown a good safety and tolerability profile in a completed Phase 1 study involving healthy volunteers.

About 4TEEN4
4TEEN4’s mission is to reverse life-threatening shock and restore organ function with procizumab. This first-in-class antibody is highly specific and blocks circulating DPP3, the key factor driving mortality in shock. Building on promising results from preclinical models and initial patient use, procizumab is currently in a Phase 1b/2a study to assess its potential as a treatment for shock caused by acute cardiovascular and septic events. By targeting the underlying cause, 4TEEN4 aims to advance shock treatment beyond supportive care and improve survival rates in critically ill patients.

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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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