atibuclimab (IC14) / Implicit Biosci - LARVOL DELTA

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy (clinicaltrials.gov) - P1/2 | N=5 | Suspended | Sponsor: Implicit Bioscience | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Cardiomyopathy • Cardiovascular • CRP

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI (clinicaltrials.gov) - P1/2 | N=10 | Active, not recruiting | Sponsor: Implicit Bioscience | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2026 ➔ Jun 2026

Enrollment closed • Trial primary completion date • Cardiovascular • Myocardial Infarction

IC14 for Treatment of Acute Decompensated Heart Failure (clinicaltrials.gov) - P1/2 | N=10 | Active, not recruiting | Sponsor: Implicit Bioscience | Trial completion date: Jan 2026 ➔ Aug 2026 | Trial primary completion date: Sep 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • CRP

Pilot and Feasibility Study of Intra-articular Anti-CD14 for the Treatment of Knee Osteoarthritis (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: VA Office of Research and Development

First-in-human • New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology

PRESEPSIN AS A BIOMARKER OF CD14 PATHWAY ACTIVATION AND ITS MODULATION WITH ATIBUCLIMAB (IC14) IN ACUTE DECOMPENSATED HEART FAILURE (ACC 2026) - P1/2 | "Presepsin levels are elevated in patients with ADHF and following treatment with atibuclimab (IC14) the levels decrease inversely to the CD14RO%. These findings highlight its potential utility for patient selection and treatment monitoring."

Biomarker • Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation • CD14 • CRP

ATIBUCLIMAB (IC14) IN ACUTE DECOMPENSATED HEART FAILURE: RESULTS OF A PHASE 1B PILOT STUDY (ACC 2026) - P1/2 | "A single IC14 dose was well tolerated and associated with >95% receptor occupancy at day 10, reduced inflammation, and improved BNP, LVEF, and quality of life, supporting progression to phase II clinical trials."

Clinical • P1 data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation • CD14 • CRP

CD14 Blockade Modulates Macrophage-Mediated Immunological Injury in a Translational Model of Reperfused ST-Segment Elevation Myocardial Infarction. (PubMed, JACC Basic Transl Sci) - "Multiomic studies suggest CD14 blockade downregulated macrophage-specific proinflammatory and tissue-wide remodeling processes without suppression of monocyte-macrophage infiltration or repair. These findings support a clinically practicable targeted immunomodulatory strategy of CD14 blockade initiated at reperfusion to prevent chronic immunological progression toward ischemic heart failure, and provide new insights into the pleiotropic roles of CD14 in inflammation and myocardial injury."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Immunology • Inflammation • Myocardial Infarction • CD14

CD14-dependent MAP kinase signaling is required for pathogenic neutrophil extracellular trap formation in APS (ACR Convergence 2025) - "Neutrophil CD14 appears to be required for the p38 MAPK-mediated neutrophil activation and NETosis reliably triggered by anti-β2GPI in APS. This work identifies neutrophil surface CD14 and downstream p38 MAPK signaling as novel therapeutic targets with the potential to restrain not only thrombosis, but also the upstream inflammation that underlies APS."

IO biomarker • Cardiovascular • Genetic Disorders • Hematological Disorders • Inflammation • Thrombosis • CD14 • ITGAM • ITGB2 • NDUFA2 • TLR4

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy (clinicaltrials.gov) - P1/2 | N=5 | Suspended | Sponsor: Implicit Bioscience | Active, not recruiting ➔ Suspended

Trial suspension • Cardiomyopathy • Cardiovascular

IC14 for Treatment of Acute Decompensated Heart Failure (clinicaltrials.gov) - P1/2 | N=10 | Active, not recruiting | Sponsor: Implicit Bioscience | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Implicit Bioscience | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lung Injury • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Implicit Bioscience | Trial completion date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction

Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Implicit Bioscience | Phase classification: P1b ➔ P1

Phase classification • Amyotrophic Lateral Sclerosis • CNS Disorders

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Implicit Bioscience | Trial completion date: Aug 2026 ➔ Oct 2027 | Trial primary completion date: Jun 2026 ➔ Aug 2027

Trial completion date • Trial primary completion date • Acute Lung Injury • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Anti-CD14 treatment in patients with severe COVID-19: Clinical and biological effects in a Phase 2 randomized open-label adaptive platform clinical trial. (PubMed, CHEST Crit Care) - P2 | "Further trials are needed to determine the efficacy of IC14 treatment in acute lung injury and the value of presepsin to identify patients most likely to respond. Clinicaltrials.gov: NCT04488081."

Journal • P2 data • Acute Lung Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CD14 • CXCL8

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy (clinicaltrials.gov) - P1/2 | N=5 | Active, not recruiting | Sponsor: Implicit Bioscience | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiomyopathy • Cardiovascular

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Implicit Bioscience | Trial completion date: Oct 2025 ➔ Jun 2026 | Trial primary completion date: Jul 2025 ➔ Dec 2025 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction • CD14

IC14 (atibuclimab) in Arrhythmogenic Cardiomyopathy (clinicaltrials.gov) - P1/2 | N=5 | Recruiting | Sponsor: Implicit Bioscience | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Feb 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular

Anti-CD14 Treatment with IC14 in Hospitalized ARDS Patients (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Implicit Bioscience | Initiation date: Aug 2024 ➔ May 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2026

Trial initiation date • Trial primary completion date • Acute Lung Injury • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

IC14 for Treatment of Acute Decompensated Heart Failure (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Implicit Bioscience | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: Implicit Bioscience

New P1/2 trial • Cardiovascular • Myocardial Infarction • CD14

IC14 for Treatment of Acute Decompensated Heart Failure (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: Implicit Bioscience

New P1/2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Implicit Bioscience

New P2 trial • Acute Lung Injury • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Anti-CD14 Treatment and Mortality in Severe COVID-19: A Secondary Subgroup Analysis by Baseline Plasma Presepsin Levels in the I-SPY COVID Adaptive Platform Trial (ATS 2024) - "Our findings suggest that a baseline marker of CD14-pathway activity, presepsin, might identify severely ill patients with viral pneumonia more likely to respond to therapy blocking CD14-mediated inflammation. Although these analyses were based on small sample size, additional studies should be conducted to further test the hypothesis that presepsin-guided IC14 therapy is beneficial in severe viral pneumonia."

Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • CD14

IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy (clinicaltrials.gov) - P1/2 | N=5 | Recruiting | Sponsor: Implicit Bioscience | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiomyopathy • Cardiovascular