Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases, today announced that the first patient has been enrolled in Marea’s Phase 2b TYDAL-TIMI 78 study evaluating MAR001 in adults with elevated levels of triglycerides (TG) and remnant cholesterol (RC) at increased risk of atherosclerotic cardiovascular disease (ASCVD). MAR001 is a monoclonal antibody delivered by subcutaneous injection that is designed to block the activity of ANGPTL4, a protein that is highly expressed in adipose tissue. MAR001 is being developed to address unmet risk in patients with ASCVD and persistently elevated levels of TG and RC.

The Phase 2b TYDAL-TIMI 78 study aims to enroll approximately 216 patients who will be randomized in a 3:1 ratio to receive MAR001 or placebo every four weeks for 24 weeks. Patients in the MAR001 arms will be randomized to receive 300mg, 450mg or 900mg. The primary endpoints will evaluate the percent change from baseline at week 12 in fasting TGs and fasting RC as compared with placebo. Safety and tolerability will be assessed, and secondary endpoints include changes in fasting very low-density lipoprotein cholesterol (VLDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C).

"Despite significant progress in managing cardiovascular risk, many patients continue to face elevated risk due to high levels of remnant cholesterol carried on triglyceride-rich lipoproteins. The TYDAL-TIMI 78 study offers an important opportunity to explore the therapeutic potential of MAR001, a genetically informed and promising approach to targeting ANGPTL4,” said Marc S. Sabatine, M.D., M.P.H., chairman of the thrombolysis in myocardial infarction (TIMI) study group and TYDAL study chair. “By addressing a major unmet need with a novel mechanism, this trial could pave the way for a new class of therapies to reduce residual risk in patients with cardiometabolic disease. We’re pleased to lead this important study and look forward to evaluating MAR001’s impact on meaningful lipid parameters and overall cardiovascular health.”

“The initiation of the TYDAL study marks an important milestone for Marea and for patients at risk of atherosclerotic cardiovascular disease,” said Josh Lehrer, M.D., chief executive officer of Marea. “MAR001 is a first-in-class, genetically validated investigational therapy with the potential to improve outcomes by reducing remnant cholesterol and triglycerides - two critical and under-addressed drivers of residual cardiovascular risk. We’re advancing MAR001 into a Phase 2b trial and aim to generate data that could shift the treatment paradigm in cardiometabolic disease. MAR001 may offer precision therapy for patients with elevated residual risk despite control of traditional factors. We expect topline TYDAL results in mid-2026 and are energized to move this innovative therapy closer to the patient.”

About MAR001

MAR001 is a monoclonal antibody designed to block the activity of ANGPTL4. MAR001 binds with high affinity to the N-terminal coiled-coil domain of ANGPTL4. Given the enrichment in expression of ANGPTL4 in adipose tissue, MAR001 leads to augmented hydrolysis of triglyceride (TG) rich lipoproteins and optimal storage of TGs, and both nonclinical and clinical studies have demonstrated significant reductions in TG and remnant cholesterol (RC), the cholesterol carried on TG-rich lipoproteins. Substantial reductions in TG and RC are predicted to reduce atherosclerotic cardiovascular disease (ASCVD) risk.

About Marea Therapeutics

Marea Therapeutics is a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardioendocrine diseases. The company’s lead therapy, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for atherosclerotic cardiovascular disease. The company is also advancing MAR002 for the treatment of acromegaly. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X.

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