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 https://clinicaltrials.gov/study/NCT06927739.

"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