A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants With Prior Myocardial Infarction Who Have Elevated Coronary Inflammation Based on FAI Score Assessed by CCTA

The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA. The main question it aims to answer is:
Clinical effects of orticumab treatment on inflammation of the coronary artery parameters measured with CCTA
Researchers will compare the effects with placebo group after 6 months of treatment
Participants will Keep the planned study visit appointments Provide complete information about medical and medical history Speak to the study doctor before changing any of non-study treatments, including starting new medications, receiving any vaccinations, or setting out to join any other clinical studies

Start Date11 Aug 2025

Sponsor / Collaborator

Abcentra LLC

NCT04776629

/ CompletedPhase 2

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Proof-of-Activity Study With Orticumab in Subjects With Moderate-to-Severe Psoriasis and Cardiometabolic Risk Factors

The primary purpose of this proof-of-activity, phase 2 trial is to evaluate the safety and activity of orticumab in subjects with moderate to severe psoriasis and cardiometabolic risk factors.

Start Date30 Jun 2021

Sponsor / Collaborator

Abcentra LLC

NCT01486823

/ CompletedPhase 1

An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

Start Date01 Nov 2011

Sponsor / Collaborator

BioInvent International AB

[+1]

100 Clinical Results associated with Orticumab

100 Translational Medicine associated with Orticumab

100 Patents (Medical) associated with Orticumab

Literatures (Medical) associated with Orticumab

29 May 2024·Cardiovascular research

Inhibition of oxidized low-density lipoprotein with orticumab inhibits coronary inflammation and reduces residual inflammatory risk in psoriasis: a pilot randomized, double-blind placebo-controlled trial

Letter

Author: Stark, Charles ; Lu, Wenqi ; Shah, Prediman K ; Farina, Christopher J ; Wright, Timothy ; Davidson, Michael H ; Shirodaria, Cheerag ; Antoniades, Charalambos A ; Nilsson, Jan ; Mehta, Nehal N

01 Jan 2014·Journal of immunology researchQ3 · MEDICINE

Proatherogenic Oxidized Low-Density Lipoprotein/β2-Glycoprotein I Complexes in Arterial and Venous Disease

Q3 · MEDICINE

ArticleOA

Author: Berger, Jeffrey S. ; Lopez, Luis R. ; Guyer, Kirk E. ; Rockman, Caron B.

OxLDL/β2GPI complexes have been implicated in the initiation and progression of atherosclerosis and associated with disease severity and adverse outcomes. We investigate the significance of anti-oxLDL/β2GPI antibodies and oxLDL/β2GPI complexes in patients with arterial and idiopathic venous disease. A cohort of 61 arterial disease patients, 32 idiopathic venous disease patients, and 53 healthy controls was studied. Because statins influence oxLDL/β2GPI, these complexes were analyzed on subjects not taking statins. Arterial and venous groups expressed higher levels of IgG anti-oxLDL/β2GPI antibodies than controls without any other significant clinical association. OxLDL/β2GPI complexes were significantly elevated in arterial (0.69 U/mL,P=0.004) and venous disease (0.54 U/mL,P=0.025) than controls (0.39 U/mL). Among arterial diseases, oxLDL/β2GPI was 0.85 U/mL for carotid artery disease, 0.72 U/mL for peripheral artery disease, and 0.52 U/mL for abdominal aortic aneurysm. There was a significant association with male gender, age, hypertension, and history of thrombosis. Subjects with oxLDL/β2GPI above the median (0.25 U/mL) were more likely to have arterial (OR 4.5,P=0.004) or venous disease (OR 4.1,P=0.008). Multivariate regression indicated that males (P=0.021), high cholesterol (P=0.011), and carotid disease (P=0.023) were significant predictors of oxLDL/β2GPI. The coexistence of oxLDL/β2GPI in arterial and venous disease may suggest a common oxidative mechanism that independently predicts carotid artery disease.

01 Jan 2008·Clinical laboratory

Oxidized LDL, anti-oxidized LDL and anti-annexin A5 antibodies in primary antiphospholipid syndrome.

Article

Author: Singh, Sandra ; Majkic-Singh, Nada ; Becarevic, Mirjana

The aim of this study was to compare whether oxidized LDL (oxLDL), anti-oxLDL and anti-annexin (anx) A5 antibodies are associated with clinical features of primary antiphospholipid syndrome (PAPS), and to compare these to well-defined groups of non-PAPS myocardial infarction survivors (non-PAPS MI) and to non-PAPS patients with pulmonary emboli (non-PAPS PE). All parameters investigated were analyzed by ELISA using commercial reagents. PAPS patients with MI, in comparison to the group of non-PAPS MI survivors, had significantly elevated concentrations of oxLDL (p = 0.003) and anti-oxLDL antibodies (p = 0.024). Anti-anxA5 antibodies of the IgG isotype were associated with recurrent abortions (OR = 4.788, p = 0.036, 95% CI: 1.104 - 20.762). OxLDL and anti-oxLDL antibodies represent additional risk factors which, together with other factors, might lead to complications of arterial thromboses, such as myocardial infarctions in PAPS, while association of IgG anti-anxA5 antibodies with recurrent abortions is a reflection of the small number of patients with this feature involved in the study and should therefore be investigated further.

News (Medical) associated with Orticumab

12 Aug 2025

·www.prnewswire.com

Abcentra LLC Announces First Patient Dosed in Phase 2b "FORTIFY" Clinical Trial Evaluating Orticumab in Patients with Cardiovascular Disease

LOS ANGELES, Aug. 12, 2025 /PRNewswire/ -- Abcentra LLC, a clinical-stage biopharmaceutical company pioneering targeted therapies for cardiovascular inflammation, today announced the successful dosing of the first patient in its Phase 2b trial, FORTIFY, evaluating orticumab in patients with a history of type 1 myocardial infarction (MI) and confirmed elevated coronary inflammation. The Company is developing orticumab for secondary prevention of cardiac events after acute coronary syndrome (ACS). The FORTIFY study is designed to confirm the anti-inflammatory activity of selected orticumab doses in the coronary arteries by assessing imaging biomarkers using coronary computed tomography angiography (CCTA). "We are proud to initiate this important trial and mark the first patient dosed as a significant milestone in our mission to bring novel, plaque-targeted anti-inflammatory therapies to patients who have suffered from acute coronary syndrome," said Christopher Farina, CEO of Abcentra. "Orticumab has the potential to significantly reduce cardiovascular risk on top of current standard of care by inhibiting inflammation locally within atherosclerotic plaques." Study Overview Study Name: FORTIFY (NCT06927739) Short Title: Focused Orticumab Research for Treating Inflammation in Coronary Arteries Design: Multi-center, randomized, placebo-controlled, double-blind trial Sites: 40 clinical sites across the U.S., United Kingdom, and Europe Patients: 240 adults with a history of type 1 MI and elevated Fat Attenuation Index (FAI) scores Arms: Two clinical dose arms of orticumab and two placebo arms Treatment Duration: 24 weeks Primary Endpoint: Reduction in FAI score at Week 24 Further details can be found at . "FAI score provides a window into local coronary artery inflammation in using CT angiography," said Dr. Peter Libby, Board Member of Abcentra, cardiovascular researcher and clinician. "By utilizing a cutting-edge imaging modality, FORTIFY aims to test orticumab's ability to reduce arterial inflammation, pathogenic processes strongly implicated in risk of a major adverse cardiovascular event." "The initiation of the FORTIFY trial represents a major step forward for Abcentra and the broader cardiovascular field," said John Farina, Chairman of the Board of Abcentra and Managing Partner of Glenbarr Partners. "We believe orticumab has the potential to become a transformative therapy in cardiovascular disease and are proud to support this innovative approach targeting coronary inflammation, a root cause of heart attacks." About Abcentra LLC Abcentra is a clinical stage biopharmaceutical company with a mission to improve treatment options for patients with coronary artery disease (CAD). Abcentra's first-in-class monoclonal antibody against oxidized LDL, orticumab, has promise to go beyond LDL lowering to quell persistent inflammation within atherosclerotic plaques, thereby offering an exciting new approach to treating patients at risk for recurrent cardiovascular events. The Company is developing orticumab for secondary prevention of cardiac events after acute coronary syndrome (ACS). In 2024, Abcentra published promising clinical data from a phase 2a pilot study, which established clinical proof-of activity of orticumab. Following the data readout, Abcentra closed a follow-on investment of $50mm led by Glenbarr Partners with participation from other existing investors. SOURCE Abcentra WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2AHA

24 Jun 2025

·www.prnewswire.com

Abcentra Announces Appointment of Dr. Peter Libby as a Board Member as it Enters Orticumab's Phase 2b Trial (FORTIFY)

LOS ANGELES, June 24, 2025 /PRNewswire/ -- Abcentra LLC (Abcentra), a clinical stage biotechnology company specializing in coronary artery disease, today announced the appointment of Dr. Peter Libby, MD as a Board Member. "We are thrilled to have Dr. Libby join Abcentra's Board. He is a renowned medical cardiologist and pioneer in elucidating the role of inflammation in cardiovascular disease. His deep expertise in cardiovascular inflammation will be critical as we raise awareness of the significant potential of plaque-targeted anti-inflammatory therapies to improve patient outcomes," said Christopher Farina, Chief Executive Officer at Abcentra. Dr. Libby is a cardiovascular specialist at Brigham and Women's Hospital in Boston, Massachusetts, and holds the Mallinckrodt Professorship of Medicine at Harvard Medical School (HMS). His areas of clinical expertise include general and preventive cardiology. His major research focus is the role of inflammation in vascular diseases, such as atherosclerosis. Dr. Libby has a particular devotion to translate his laboratory studies to pilot and then large-scale clinical cardiovascular outcome trials. "Dr. Libby is a world-renowned cardiologist pushing the frontier of inflammation in cardiovascular disease. He has been pivotal in developing the next generation of cardiovascular treatments recently serving as a leader of CANTOS and a member of the Scientific Advisory Board for Corvidia Therapeutics (acquired by Novo Nordisk). It is my great pleasure to extend a warm welcome to Peter on behalf of my colleagues on Abcentra's Board. His input has already been very valuable in planning FORTIFY. We look forward to working with him closely as the Company prepares for Phase 3," said Dr. Michael Davidson, Board Member and CEO of New Amsterdam Pharma. "This time is a transformational period for Abcentra as it continues to advance its therapeutic program into a phase 2b clinical trial in patients with a history of myocardial infarction and elevated coronary inflammation. I am excited to join the Abcentra Board and collaborate with fellow board members and management to continue the Company's momentum in developing novel anti-inflammatory approaches," said Dr. Libby. Dr. Libby has authored over 560 original publications in peer reviewed journals and is Editor of the leading textbook of cardiovascular medicine, Braunwald's Heart Disease. His research has received funding from the American Heart Association and National Institutes of Health. Dr. Libby has received world-wide research recognitions, including the highest research awards from the American Heart Association and American College of Cardiology, the Gold Medal of the European Society of Cardiology, the Anitchkow award from the European Atherosclerosis Society, The Ernst Jung Gold Medal for Medicine, and the Earl Benditt award for vascular biology. Dr. Libby earned his medical degree at the University of California, San Diego, and completed his training in internal medicine and cardiology at the Peter Bent Brigham Hospital (now part of MassGeneralBrigham). He also holds an honorary MA degree from Harvard University, and honorary doctorates from the University of Lille, Université Laval, and Goethe University. About Abcentra LLC Abcentra is a clinical stage biopharmaceutical company with a mission to improve treatment options for patients with coronary artery disease (CAD). Abcentra's first-in-class monoclonal antibody, orticumab, has promise to go beyond LDL lowering to quell persistent inflammation within atherosclerotic plaques, thereby offering an exciting new approach to treating patients at risk for recurrent cardiovascular events. The Company is developing orticumab for secondary prevention of cardiac events after an acute coronary syndrome (ACS). In 2024, Abcentra published promising clinical data from a phase 2a pilot study, which established clinical proof-of activity of orticumab. Following the data readout, Abcentra closed a follow-on investment of $50mm last year from existing investors that funds the program through phase 2b. About Orticumab's Phase 2b Clinical Study (FORTIFY) The FORTIFY trial will evaluate the effect of orticumab on coronary inflammation in patients with a history of myocardial infarction and elevated coronary inflammation. Further details can be found at . SOURCE Abcentra WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive ChangePhase 2AHA

100 Deals associated with Orticumab

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Coronary Syndrome	Phase 2	United States	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Czechia	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Hungary	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Italy	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Poland	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Romania	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Spain	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	Sweden	Abcentra LLC	11 Aug 2025
Acute Coronary Syndrome	Phase 2	United Kingdom	Abcentra LLC	11 Aug 2025
Non-St Elevated Myocardial Infarction	Phase 2	United States	Abcentra LLC	11 Aug 2025

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