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

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