Implicit Bioscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IC14 (atibuclimab) for the treatment of patients hospitalized with acute decompensated heart failure (ADHF).
Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious conditions and address unmet medical needs. The designation enables more frequent interactions with the FDA, eligibility for rolling review of a future Biologics License Application (BLA), and the potential for Priority Review.
IC14 is a first-in-class monoclonal antibody targeting CD14, a central regulator of the immune response involved in inflammation, fibrosis and tissue injury. In acute decompensated heart failure, excessive activation of innate immune pathways contributes to congestion and myocardial dysfunction, resulting in death.
The Fast Track designation is supported by encouraging results from Implicit Bioscience’s recent Phase 1b clinical study in hospitalized patients with acute decompensated heart failure in the USA. In this study, a single adjunctive dose of IC14 demonstrated a favorable safety and tolerability profile and:
- High target engagement (CD14 receptor occupancy)
- Significant reductions in inflammatory biomarkers (including CRP and presepsin)
- Meaningful improvements in heart failure biomarkers (BNP)
- Rapid and sustained improvements in patient-reported dyspnea and KCCQ scores
- Rapid improvements in congestion scores and left ventricular ejection fraction
“These data support the role of innate immune activation in acute decompensated heart failure and highlight CD14 as a compelling therapeutic target,” said Garry Redlich, Implicit Bioscience CEO. “Fast Track designation validates the potential of IC14 to address a major unmet medical need and enables us to work more closely with the FDA as we advance into Phase 2 development.”
Acute decompensated heart failure is a leading cause of hospitalization worldwide and is associated with high short-term mortality, frequent readmissions, and substantial healthcare costs. Despite advances in chronic heart failure therapy, there are currently no approved disease-modifying anti-inflammatory treatments for ADHF.
Implicit Bioscience plans to initiate a randomized Phase 2 clinical trial to further evaluate the efficacy, safety, and biomarker effects of IC14 in patients hospitalized with acute decompensated heart failure.
About IC14 (atibuclimab)
IC14 is a monoclonal antibody targeting CD14, a co-receptor involved in innate immune activation in response to pathogen- and damage-associated molecular patterns. By modulating CD14-mediated inflammatory signaling, IC14 is designed to reduce maladaptive inflammation while preserving essential host defense mechanisms.