Abcentra Initiates Phase 2b FORTIFY Trial for Novel Anti-Inflammatory Cardiovascular Therapy Orticumab
核心洞察
Abcentra LLC (搜索) has dosed the first patient in its Phase 2b FORTIFY trial evaluating orticumab, a first-in-class monoclonal antibody targeting oxidized LDL for secondary prevention of cardiac events.
The multi-center, placebo-controlled trial will enroll 240 patients with a history of type 1 myocardial infarction and elevated coronary inflammation across 40 sites in the U.S., UK, and Europe.
Orticumab aims to reduce cardiovascular risk by inhibiting inflammation locally within atherosclerotic plaques, potentially offering a transformative approach beyond current LDL-lowering therapies.
Abcentra LLC (搜索), a clinical-stage biopharmaceutical company focused on cardiovascular inflammation therapies, has successfully dosed the first patient in its Phase 2b FORTIFY trial evaluating orticumab in patients with a history of type 1 myocardial infarction and confirmed elevated coronary inflammation. The company is developing orticumab for secondary prevention of cardiac events after acute coronary syndrome.
Novel Approach to Cardiovascular Risk Reduction
Orticumab represents a first-in-class monoclonal antibody against oxidized LDL designed to target inflammation within atherosclerotic plaques. "Orticumab has the potential to significantly reduce cardiovascular risk on top of current standard of care by inhibiting inflammation locally within atherosclerotic plaques," said Christopher Farina, CEO of Abcentra.
The therapeutic approach aims to go beyond traditional LDL lowering strategies by directly addressing persistent inflammation within atherosclerotic plaques, offering a new treatment paradigm for patients at risk for recurrent cardiovascular events.
FORTIFY Trial Design and Objectives
The FORTIFY study (NCT06927739) is designed as a multi-center, randomized, placebo-controlled, double-blind trial that will confirm the anti-inflammatory activity of selected orticumab doses in coronary arteries. The trial will utilize coronary computed tomography angiography (CCTA) to assess imaging biomarkers.
The study will enroll 240 adults with a history of type 1 MI and elevated Fat Attenuation Index (FAI) scores across 40 clinical sites in the United States, United Kingdom, and Europe. Patients will be randomized to two clinical dose arms of orticumab or two placebo arms for a treatment duration of 24 weeks.
Primary Endpoint and Imaging Innovation
The primary endpoint focuses on reduction in FAI score at Week 24, utilizing cutting-edge imaging technology to measure treatment efficacy. "FAI score provides a window into local coronary artery inflammation in using CT angiography," explained Dr. Peter Libby, Board Member of Abcentra and cardiovascular researcher. "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."
Clinical Development Progress
Abcentra's development program builds on promising clinical data from a Phase 2a pilot study published in 2024, which established clinical proof-of-activity for orticumab. Following the positive data readout, the company secured a $50 million follow-on investment led by Glenbarr Partners (搜索) with participation from existing investors.
"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 (搜索). "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."