4TEEN4's Invobenitug Receives FDA Fast Track Designation for Cardiogenic Shock
核心洞察
The U.S. FDA granted Fast Track Designation to 4TEEN4's invobenitug (搜索), a first-in-class monoclonal antibody targeting cDPP3 for the treatment of cardiogenic shock (搜索).
Cardiogenic shock (搜索) carries mortality rates exceeding 50% and currently has no approved pharmacologic therapies that target its underlying molecular mechanisms.
Invobenitug (搜索) is being evaluated in the Phase 1b/2a PROCARD 2a trial, building on favorable safety data from a completed Phase 1 study in healthy volunteers.
4TEEN4 Pharmaceuticals GmbH (搜索) announced on July 16, 2026 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to invobenitug (搜索) (formerly known as procizumab) for the treatment of cardiogenic shock (搜索). Invobenitug is the company's lead investigational monoclonal antibody targeting circulating dipeptidyl peptidase 3 (搜索) (cDPP3), a key pathological driver of mortality in shock. The designation marks a significant regulatory milestone for what could become one of the first targeted therapeutic approaches for this life-threatening condition.
"Fast Track designation represents an important milestone for 4TEEN4 as we continue to advance invobenitug (搜索) through clinical development," said Dr. Andreas Bergmann, CEO of 4TEEN4 Pharmaceuticals. "The designation recognizes both the significant unmet medical need in cardiogenic shock (搜索) and the potential of invobenitug as a targeted therapeutic approach."
The Unmet Need in Cardiogenic Shock (搜索)
Cardiogenic shock (搜索) is a rapidly progressive, life-threatening syndrome 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 accounts for approximately one in three admissions to intensive care units and represents the second most common form of circulatory failure, most often triggered by acute myocardial infarction or acute decompensated heart failure.
Despite advances in supportive care, mortality rates exceed 50%, and no approved pharmacologic therapy specifically targets the molecular mechanisms of cardiogenic shock (搜索). "Cardiogenic shock remains one of the most challenging conditions in acute cardiovascular medicine, with mortality rates exceeding 50% and no approved therapies that target the underlying biology," commented Alexandre Mebazaa, MD, PhD, Professor of Medicine at Université Paris Cité and Principal Investigator for the ongoing PROCARD 2a study.
Mechanism of Action: Targeting 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.
Invobenitug (搜索), a humanized monoclonal antibody, is designed to selectively target and inhibit cDPP3 activity, thereby restoring RAAS balance and stabilizing cardiovascular function. "Rather than simply treating the downstream consequences of shock, our goal is to intervene at its biological root by neutralizing cDPP3 in patients most likely to benefit," said Mebazaa. "This designation marks an important step towards establishing one of the first targeted therapeutic approaches for cardiogenic shock (搜索)."
Clinical Development Program
Invobenitug (搜索) is currently being evaluated in PROCARD 2a (NCT06832722), a multicenter, randomized, placebo-controlled, double-blind Phase 1b/2a trial. The study is assessing safety, tolerability, pharmacokinetics, and exploratory efficacy in patients with cardiogenic shock (搜索) and elevated cDPP3 concentrations.
The therapeutic potential of invobenitug (搜索) has been demonstrated in preclinical and clinical settings, where it effectively normalized cardiovascular parameters, reversed organ dysfunction, and increased survival. A completed Phase 1 study in healthy volunteers showed a favorable safety and tolerability profile. Dr. Bergmann noted the company is "building on encouraging preclinical findings and favorable safety and tolerability data from our Phase 1 study in healthy volunteers."
Regulatory Implications
Fast Track Designation is intended to facilitate the development and expedite the regulatory review of investigational therapies for serious conditions that have the potential to address an unmet medical need. The designation provides opportunities for more frequent interactions with the FDA throughout development, as well as potential eligibility for Rolling Review, Accelerated Approval, and Priority Review, where applicable.
4TEEN4, a clinical-stage biotechnology company based in Hennigsdorf/Berlin, is developing invobenitug (搜索) as a potential biomarker-guided therapy specifically for patients with cardiogenic shock (搜索) associated with elevated cDPP3. By targeting the root cause of shock, the company aims to move shock treatment beyond supportive care and improve survival in critically ill patients.