orticumab (BI 204) / Roche, BioInvent, Abcentra - LARVOL DELTA

FORTIFY: a phase 2b randomised trial evaluating the effect of orticumab on coronary inflammation (FAI-Score) in post myocardial infarction patients selects for patients with high residual FAI-Score (ESC 2026) - "Similar patterns were observed for LCx and RCA. Conclusions These findings support the feasibility of use of FAI score as an enrichment strategy for residual coronary inflammation and support the choice of studying a stable population >6 months post-MI, where substantial coronary inflammation persists despite contemporary secondary prevention."

Clinical • P2b data • Cardiovascular • Myocardial Infarction

High prevalence of local coronary arterial inflammation in clinically stable subjects after myocardial infarction: findings from the FORTIFY trial screenees (ESC 2026) - "Conclusion In clinically stable post-MI patients with well-controlled traditional risk factors, residual coronary inflammation assessed by FAI-Score appears common, despite low risk LDL-C concentrations, and spans a wide range, with many exhibiting high-inflammation. FORTIFY will assess whether adding orticumab to post-MI standard of care will further reduce coronary inflammation (FAI-Score) in randomized participants with high residual coronary inflammation."

Clinical • Cardiovascular • Coronary Artery Disease • Dyslipidemia • Myocardial Infarction

ORT-2024-02: FORTIFY Focused Orticumab Research for Treating inflammation in Coronary Arteries (clinicaltrialsregister.eu) - P1/2 | N=184 | Recruiting | Sponsor: Abcentra LLC

New P1/2 trial • Atherosclerosis • Cardiovascular • Inflammation • Myocardial Infarction

FORTIFY: Focused Orticumab Research for Treating Inflammation in Coronary Arteries (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Abcentra | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure • Inflammation • Myocardial Infarction

Orticumab: the potential to harness oxidized LDL to reduce coronary inflammation with plaque-targeted therapy. (PubMed, Curr Opin Lipidol) - "Treatment with orticumab represents a new and plaque-specific way to reduce arterial inflammation."

Clinical • Journal • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Dermatology • Dyslipidemia • Immunology • Inflammation • Myocardial Infarction • Psoriasis

FORTIFY: Focused Orticumab Research for Treating Inflammation in Coronary Arteries (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Abcentra

New P2 trial • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Heart Failure • Inflammation • Myocardial Infarction

ORTICUMAB, AN ANTIBODY AGAINST A SPECIFIC OXIDIZED LOW-DENSITY LIPOPROTEIN (OXLDL) EPITOPE, REDUCES CORONARY INFLAMMATION IN HIGH-RISK PATIENTS WITH PSORIASIS: A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL (ACC 2024) - "Orticumab exerts anti-inflammatory effects on the coronary arteries of patients with psoriasis, leading to a ~50% relative reduction of the predicted risk for fatal cardiac events by CaRi-Risk. These findings call for a larger trial to explore the effect of orticumab on coronary inflammation and atherogenesis."

Clinical • Atherosclerosis • Dermatology • Dyslipidemia • Immunology • Inflammation • Psoriasis

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. (PubMed, Cardiovasc Res) - No abstract available

Clinical • Journal • Dermatology • Dyslipidemia • Immunology • Inflammation • Psoriasis

A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors (clinicaltrials.gov) - P2 | N=77 | Completed | Sponsor: Abcentra | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease • Dermatology • Immunology • Inflammation • Metabolic Disorders • Psoriasis

A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors (clinicaltrials.gov) - P2 | N=77 | Active, not recruiting | Sponsor: Abcentra | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Coronary Artery Disease • Dermatology • Immunology • Inflammation • Metabolic Disorders • Psoriasis

Abcentra Announces First Patients Dosed with Orticumab in Clinical Trial Evaluating Blockade of Oxidized LDL in Psoriasis with Elevated Cardiometabolic Risk (PRNewswire) - "...Abcentra LLC announced that the first patients have been dosed in its multi-center phase 2 trial assessing the safety and activity of orticumab in patients with moderate-to-severe plaque psoriasis and cardiometabolic risk factors...Seventeen (17) clinical trial centers across the United States are participating."

Trial status • Cardiovascular • Psoriasis

A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: Abcentra; Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Coronary Artery Disease • Dermatology • Immunology • Inflammation • Metabolic Disorders • Psoriasis

Immune responses against oxidized LDL as possible targets for prevention of atherosclerosis in systemic lupus erythematosus. (PubMed, Vascul Pharmacol) - "Treatment with the oxidized LDL-specific antibody Orticumab reduced aortic atherosclerosis by 43%, subvalvular plaque area by 50% and the macrophage content by 31%. The present study provides support for oxLDL as a possible target for prevention of cardiovascular complications in SLE."

Journal • Atherosclerosis • Cardiovascular • Cholera • Dyslipidemia • Immunology • Inflammatory Arthritis • Lupus • Scleroderma • Systemic Lupus Erythematosus • APOB • APOE

A Proof-of-Activity Study With Orticumab in Subjects With Psoriasis and Cardiometabolic Risk Factors (clinicaltrials.gov) - P2; N=75; Not yet recruiting; Sponsor: Abcentra

Clinical • New P2 trial • Cardiovascular • Coronary Artery Disease • Dermatology • Immunology • Inflammation • Metabolic Disorders • Psoriasis

Announcement of topline results from the GLACIER study (BioInvent) - P2a, N=147; GLACIER; No statistically significant reduction between PBO & the two active treatment arms was observed; Study did not meet its primary endpoint; Based on preliminary safety data review, BI 204 was well tolerated & no drug related safety signals were identified; An analysis of additional safety & efficacy data will be available at a later date

P2a data • Dyslipidemia