MAR001 / Marea Therap - LARVOL DELTA

Antibody-Based Therapeutics for Hypercholesterolemia. (PubMed, Biologics) - "In recent years the mAbs, alirocumab and evolocumab, targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) have become established worldwide as an additional treatment for patients not achieving LDL cholesterol goals on statins and ezetimibe, or sometimes as an alternative treatment in those with statin intolerance...New drug targets were identified to potentially reduce elevated triglyceride levels and the mAb angiopoietin-like 3 (ANGPTL3) inhibitor, evinacumab, was found to be effective in reducing LDL cholesterol in patients with homozygous familial hypercholesterolemia (FH) and has been approved for that indication. SHR-1918 is another mAb targeting ANGPTL3 being developed in China which may also be effective to treat homozygous FH...Another mAb at an early stage of development is MAR001 targeting angiopoietin-like 4 (ANGPTL4). The role for this remains to be established."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders • ANGPTL3

A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Marea Therapeutics

New P2 trial • Dyslipidemia • Hypertriglyceridemia

TYDAL-TIMI 78: Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol (clinicaltrials.gov) - P2 | N=216 | Recruiting | Sponsor: Marea Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Hypertriglyceridemia

TYDAL-TIMI 78: Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol (clinicaltrials.gov) - P2 | N=216 | Not yet recruiting | Sponsor: Marea Therapeutics

New P2 trial • Dyslipidemia • Hypertriglyceridemia

Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies. (PubMed, Lancet) - P1/2 | "ANGPTL4 inhibition with MAR001 can safely and effectively reduce circulating triglycerides and remnant cholesterol. The findings of these trials support further research and development of MAR001 as a promising potential lipid-lowering therapy to reduce risk of ASCVD."

Journal • P1/2 data • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Inflammation • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

An ANGPTL4 inhibitory antibody safely improves lipid profiles in non-human primates. (PubMed, EBioMedicine) - "MAR001 improved plasma lipid profiles in NHPs without clinical adversity, even during prolonged HSFD feeding. The favourable NHP safety profile aligns with human ANGPTL4 LoF findings, and contrasts with the severe pathology in mouse knockout models on an HSFD. These findings supported MAR001 clinical studies reported in our concurrent publication, which demonstrated robust lipid improvements without lymphatic pathology. Overall, these findings support continued development of MAR001 as a promising new therapy for ASCVD risk reduction."

Journal • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Fibrosis • Immunology • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

Study of MAR001 in Adults With Metabolic Dysfunction (clinicaltrials.gov) - P1/2 | N=55 | Completed | Sponsor: Marea Therapeutics | Active, not recruiting ➔ Completed | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion • Trial primary completion date • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Study of MAR001 in Adults With Metabolic Dysfunction (clinicaltrials.gov) - P1/2 | N=48 | Active, not recruiting | Sponsor: Marea Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Study of MAR001 in Adults With Metabolic Dysfunction (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Marea Therapeutics | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Jul 2024 ➔ Nov 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Phase classification • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders

Study of MAR001 in Adults With Metabolic Dysfunction (clinicaltrials.gov) - P1b/2a | N=48 | Recruiting | Sponsor: Marea Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders