invobenitug (AK1967) / 4TEEN4 Pharmaceuticals - LARVOL DELTA

4TEEN4 Receives U.S. FDA Fast Track Designation for Invobenitug in Cardiogenic Shock (GlobeNewswire) - "It is currently being evaluated in PROCARD 2a (NCT06832722), a multicenter, randomized, placebo-controlled, double-blind Phase 1b/2a trial assessing its safety, tolerability, pharmacokinetics, and exploratory efficacy in patients with CS and elevated cDPP3 concentrations."

Fast track • Cardiovascular

PROCARD 1b: Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | N=130 ➔ 90

Enrollment change • Cardiovascular

Development and non-clinical characterization of Procizumab (invobenitug): a humanized antibody neutralizing circulating DPP3. (PubMed, MAbs) - "Finally, dose-range finding studies evaluating PCZ efficacy and safety were conducted in an acute cardiac dysfunction mouse model. Inhibition of circulating DPP3 activity represents a novel therapeutic approach for the treatment of shock, and PCZ is currently under investigation in clinical studies."

Journal

Safety, tolerability, and pharmacokinetics/-dynamics of the dipeptidyl peptidase 3-inhibiting antibody Procizumab in a first-in-human trial. (PubMed, MAbs) - P1, P1/2 | "A volume of distribution of roughly 9.8-10.2 liters indicates that the drug predominantly remains within the circulation. Results of this trial are currently being followed up in the PROCARD Phase 1b/2a (NCT06832722) study, which is evaluating safety and determining the optimal dose of PCZ in cardiogenic shock patients."

Clinical • First-in-human • Journal • P1 data • PK/PD data • Cardiovascular

Preclinical safety evaluation of the dipeptidyl peptidase 3 inhibiting antibody Procizumab in rodents and non-human primates. (PubMed, MAbs) - P1 | "These findings demonstrate that intravenous, repeated administration of high doses of PCZ was well tolerated in mice and cynomolgus monkeys. Results of this study were followed by a Phase 1 safety assessment of PCZ in humans, with single-administration clinical doses of 3, 6, and 12 mg/kg (NCT06331884)."

Journal • Preclinical

PROCARD 1b: Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | Trial completion date: Apr 2026 ➔ Dec 2026 | Trial primary completion date: Mar 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Cardiovascular

PROCARD 1b: Public title :A Phase 1b/2a trial to evaluate Invobenitug also known as Procizumab (PCZ; AK1967) in critical cardiovascular care. (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | Phase classification: P1 ➔ P1/2

Phase classification • Acute Coronary Syndrome • Cardiovascular • Heart Failure

One Enzyme, Many Faces: The Expanding Role of DPP3 in Cardiovascular and Critical Care. (PubMed, J Clin Med) - "This review outlines the physiological mechanisms, clinical implications, and emerging therapeutic potential of DPP3 in cardiovascular and critical care. Ongoing trials with Procizumab will clarify whether neutralizing cDPP3 can improve outcomes in patients with cardiogenic and septic shock."

Journal • Review • Acute Coronary Syndrome • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Critical care • Heart Failure • Infectious Disease • Inflammation • Novel Coronavirus Disease • Septic Shock

PROCARD 1b: Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular

PROCARD 1b: Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | Initiation date: Mar 2026 ➔ Jul 2025

Trial initiation date • Cardiovascular

PROCARD 1b: Procizumab (PCZ; AK1967) in Critical Cardiovascular Care (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: 4TEEN4 Pharmaceuticals GmbH | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • Cardiovascular