4TEEN4 Pharmaceuticals develops precision medicine in critical care! Our therapy aims to restore cardiac and vascular function and reduce mortality in acute cardiovascular complications with limited effective therapies available.
First-in-class
treatment for Shock –
saving lives!
Unmet medical need
Circulatory failure, also known as Shock, due to AMI (acute myocardial infarction), ADHF (acute decompensated heart failure), sepsis, trauma, burns, major surgeries, and other causes is a common reason for admission to intensive care units (ICU) and observed in approximately one out of three patients while in the ICU1. Shock remains an unaddressed medical condition with NO adequate causal therapy available and mortality rates exceeding 50%2,3.
Our therapeutic focus
We identified a key shock mediator – cDPP3 (circulating Dipeptidyl Peptidase 3) - and are in clinical development stage of a cDPP3 inhibitor, Procizumab (also known as PCZ, AK1967), which is a first-in-class antibody for the treatment of shock4–7.
Our development strategy
The Phase 1b/2a trial in cardiogenic shock patients with elevated cDPP3 will start in Q1 2025 establishing a PCZ dosing regimen to be used in the following pivotal Phase 2/3 clinical proof-of-concept study in cardiogenic shock patients.
Cardiogenic shock (CS) is an acute life-threatening condition accounting for more than 100,000 deaths per year in the U.S. & Europe alone. CS is a tremendous cost burden for society with an average cost per patient of US$ 150 to 190k in the U.S.8
cDPP3 is a prognostic marker and a major cause of circulatory failure and, ultimately, death. The harmful cDPP3 pathway has been validated in more than 100,000 patients in 90 clinical studies across 350 clinical sites in 17 countries in conditions such as shock due to cardiac failure, burns, major surgery and septic myocardiopathy.
PCZ is a humanized monoclonal antibody that binds and inhibits cDPP3 and, hence, restores control over RAAS, normalizes cardiovascular function, reverses organ dysfunction, and increases survival. Non-clinical efficacy and safety of PCZ were demonstrated in three independent efficacy models4,5,7.
The project is funded by the European Social Fund (ESF) and the Federal State of Brandenburg via the Brandeburg Ministry for Labor, Social Affairs, Health, Women and Family (MASGF).