MAR-001 Shows Promise in Cardiovascular Risk Trial

“We are very excited by these data from our Phase IIa study, which demonstrate the strong potential of MAR 001 to address the most important unaddressed lipid and metabolic drivers of atherosclerotic cardiovascular disease in high-risk patients,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “We look forward to advancing MAR 001 into Phase IIb development for treating residual cardiovascular risk in patients who remain at highest risk despite aggressive standard of care therapies.”

“Atherosclerotic cardiovascular disease patients with elevated remnant cholesterol remain at an increased risk for major adverse cardiovascular events despite best available standard of care therapies,” said Ethan Weiss, M.D., chief scientific officer of Marea. “These data clearly validate the ability of MAR 001 to significantly lower remnant cholesterol and triglycerides by inhibiting ANGPTL4, supporting genetic findings and expected translation to substantial cardiovascular disease risk reduction. We believe MAR 001 has the potential to become an important new therapeutic option for patients.”

Presentation Highlights:

• i. The primary objective of Marea’s randomized, double-blind, placebo-controlled Phase IIa clinical trial was to characterize the safety and tolerability of multiple doses of MAR 001 in participants with elevated triglycerides and remnant cholesterol.
• ii. Secondary objectives were to describe the serum concentration of MAR 001 at selected timepoints and to characterize the effect of MAR 001 on triglyceride and remnant cholesterol metabolism following 12 weeks of treatment.
• iii. The study enrolled 55 participants with hypertriglyceridemia (fasting TGs ≥151 and ≤496 mg/dL) randomized to Q2W MAR 001 or placebo (blinded, 2:1 MAR 001:Placebo). Ten participants were randomized to the 150 mg MAR 001 arm, nine to the 300 mg MAR 001 arm, 17 to the 450 mg MAR 001 arm, and 19 to placebo.
• iv. MAR 001 demonstrated up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in triglycerides at 12 weeks.
• v. In participants with significantly elevated triglyceride levels at baseline (≥200 mg/dL), MAR 001 demonstrated up to a 66.0% placebo-adjusted mean reduction in remnant cholesterol and up to a 64.0% placebo-adjusted mean reduction in triglycerides at Week 12.
• vii. MAR 001 was generally well tolerated, with no clinically significant findings, and no findings of elevated systemic inflammatory biomarkers or changes in mesenteric lymph node (MLN) size or local inflammation as assessed by MRI. There were no deaths or serious adverse events in any arm, and no adverse events with MAR 001 leading to study drug discontinuation.