Atibuclimab for Heart Attack

Recruiting at 3 trial locations

Overseen By Garry Redlich

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Implicit Bioscience

Must not be taking: Immunosuppressives, Anti-inflammatories

Disqualifiers: Heart failure, Valve disease, Infections, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called atibuclimab, a monoclonal antibody, to determine if it can aid recovery after a severe heart attack. The goal is to assess whether this treatment improves heart function and reduces inflammation compared to a placebo (inactive treatment). Individuals who experienced a heart attack with symptoms appearing within the last 12 hours and received a stent may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have used immunosuppressive or anti-inflammatory drugs recently, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that atibuclimab, a monoclonal antibody, has been tested for safety in other health conditions. In a past study, patients with arrhythmogenic cardiomyopathy received atibuclimab through an IV drip. This study primarily assessed safety and found the medicine was generally well-tolerated, with no major safety concerns reported.

Atibuclimab targets inflammation, a key factor in many heart problems. Research suggests this could help without causing significant harm. Although specific side effects weren't listed, the absence of major issues in earlier studies is promising.

This current trial is in the early stages (Phase 1 and Phase 2), so the treatment's safety is still under careful observation. However, earlier study results provide some reassurance about its safety. Participants should discuss any potential risks with their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for heart attacks, which often involve medications like aspirin, beta-blockers, and ACE inhibitors, Atibuclimab targets a different pathway. Researchers are excited about Atibuclimab because it is a monoclonal antibody that targets CD14, a molecule involved in the inflammatory response that occurs after a heart attack. This unique mechanism could potentially reduce inflammation more directly, offering a new way to protect heart tissue and improve recovery. By focusing on inflammation, Atibuclimab might offer benefits that current therapies don't fully address, making it a promising option for heart attack patients.

What evidence suggests that Atibuclimab might be an effective treatment for heart attack?

Research has shown that atibuclimab, a monoclonal antibody, may help treat heart problems. In this trial, participants will receive either atibuclimab or a placebo. In earlier studies, a similar medication prevented heart function from worsening after a heart attack by blocking a key cause of inflammation, reducing damage to the heart muscle. Another study found that targeting this inflammation trigger could be important for managing heart-related inflammation. These findings suggest that atibuclimab might improve heart function and reduce inflammation after a heart attack. ^{2 3 4 5 6}

Who Is on the Research Team?

Marc Sintek, MD

Principal Investigator

PI

Antonio Abbate, MD, PhD

Principal Investigator

PI

Are You a Good Fit for This Trial?

This trial is for adults who've had a severe type of heart attack known as ST-elevation myocardial infarction (STEMI) and have been treated with stent placement. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

I am scheduled for a standard heart attack treatment including a procedure to open my heart's arteries.

TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram

I have had a heart attack confirmed by an ECG.

Exclusion Criteria

Body weight >300 pounds (weight limit of the PET/CT table)

I have not had major surgery in the last 6 weeks.

I have not had major blood vessel surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single IV infusion of IC14 (atibuclimab) or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker assessments and cardiac function evaluations

12 weeks

Multiple visits (in-person) on Day 4, 15, 29, and 90

Optional Imaging

Optional CCR2+ myocardial imaging to assess myocardial infiltration

15 days

1 visit (in-person) on Day 15

What Are the Treatments Tested in This Trial?

Interventions

• Atibuclimab

Trial Overview

The study is testing Atibuclimab (IC14), an anti-CD14 monoclonal antibody, given once via IV at 20 mg/kg, against a placebo consisting of 150 mL saline solution also given once via IV. The aim is to see if Atibuclimab can prevent further damage to heart muscle and improve heart function.

How Is the Trial Designed?

Group I: Experimental drug intervention Experimental Treatment 1 Intervention

monoclonal antibody against CD14

Group II: Placebo Placebo Group 1 Intervention

Identical-appearing normal saline for injection, intravenous, once

Atibuclimab is already approved in United States for the following indications:

Approved in United States as Atibuclimab for:

• Acute Decompensated Heart Failure (clinical trial phase, not yet approved)

Who Is Running the Clinical Trial?

Implicit Bioscience

Lead Sponsor

Trials

12

Recruited

140+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

In a study using a mouse model of heart failure after myocardial infarction, 71% of male and 44% of female mice developed cardiac autoantibodies (cAAbs) against cardiac troponin I, which were linked to worse cardiac remodeling and prognosis.

Treatment with rapamycin significantly reduced the production of these cAAbs, leading to improved survival and reduced cardiac inflammation and remodeling, suggesting a potential therapeutic approach for managing heart failure related to cAAbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Autoantibodies Against Cardiac Troponin I in Post-Myocardial Infarction Heart Failure: Evaluation in a Novel Murine Model and Applications in Therapeutics. Furusawa, S., Ikeda, M., Ide, T., et al.[2023]

cMyBP-C autoantibodies (AAbs) were significantly present in patients with acute coronary syndrome (ACS), especially those with ST-elevation myocardial infarction (STEMI), indicating a potential early marker for cardiac damage.

The presence of cMyBP-C-AAbs was associated with reduced left ventricular ejection fraction (LVEF) and higher levels of myocardial infarction biomarkers, suggesting they could predict worsening cardiac function and patient outcomes before an infarction occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Myosin Binding Protein-C Autoantibodies are Potential Early Indicators of Cardiac Dysfunction and Patient Outcome in Acute Coronary Syndrome. Lynch, TL., Kuster, DWD., Gonzalez, B., et al.[2020]

In a study of 1072 patients suspected of having non-ST segment elevation acute myocardial infarction (NSTEMI), the autoantibodies anti-apoA-1 IgG and anti-PC IgM showed very low diagnostic accuracy for NSTEMI, with area under the curve (AUC) values of 0.50 and 0.53, respectively, indicating they are not effective for diagnosis.

The same autoantibodies also demonstrated low prognostic accuracy for predicting major adverse cardiovascular events (MACE) during a 1-year follow-up, suggesting they do not provide useful information for patient outcomes in NSTEMI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic and prognostic value of autoantibodies anti-apolipoprotein A-1 and anti-phosphorylcholine in acute non-ST elevation myocardial infarction. Rubini Gimenez, M., Pagano, S., Virzi, J., et al.[2015]

In a study of 491 patients with first ST-elevation myocardial infarction (STEMI), autoantibodies against the β1-adrenoceptor (β1-aab) were found in 39.1% of patients, while cardiac troponin-I autoantibodies (anti-cTnI) were present in 19.1%, indicating their prevalence in this condition.

Both β1-aab and anti-cTnI were identified as independent predictors of left ventricular remodeling after STEMI, but only β1-aab was strongly associated with major adverse cardiovascular events (MACEs), suggesting its potential role in worsening outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prognostic value of autoantibodies against β1-adrenoceptor and cardiac troponin-I for clinical outcomes in STEMI. Fan, Y., Chen, Y., Wan, Z., et al.[2017]

In a study of 99 patients with autoimmune myocarditis (AM), the presence of autoantibodies (AAB) with catalytic activity was found to correlate with the severity of the disease, particularly in malignant cases where 73% showed high specific activity of protabzymes.

The evaluation of catalytic activity of AAB can serve as a valuable tool for assessing the stage and prognosis of AM, as it helps differentiate between malignant, benign, and myocardiosclerosis forms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catalytic autoantibodies in autoimmune myocarditis: clinical and pathogenetic implications]. Kalinina, EV., Ponomarenko, NA., Durova, OM., et al.[2006]

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This proof-of-concept study will evaluate the safety, pharmacokinetics, and preliminary efficacy of IC14 administered via IV infusion in patients with ACM.

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Media Release | FDA Approves Implicit Drug for Clinical ...

Atibuclimab targets a central regulator of inflammation that has recently been shown in a thirty-year study to be more predictive of adverse ...

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The goal is to learn if this treatment improves some measures of heart function and inflammation. The study treatment patients will be compared ...

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Anti-CD14 antibody therapy with a murine analogue of atibuclimab mitigated post-acute progression of left ventricular dysfunction, ...

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sciencedirect.com/science/article/pii/S2452302X25003468

CD14 Blockade Modulates Macrophage-Mediated ...

Anti-CD14 antibody therapy with a murine analogue of atibuclimab mitigated post-acute progression of left ventricular dysfunction, ...

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IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy - Cli...

This proof-of-concept study will evaluate the safety, pharmacokinetics, and preliminary efficacy of IC14 administered via IV infusion in ...