Positive topline results from Phase 2a study of MAR001 demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides; Phase 2b study expected to initiate in First Half 2025
Second Lead Program announced, MAR002, a growth hormone receptor (GHR) antagonist for the treatment of acromegaly; Phase 1 study expected to initiate in Second Half 2025
Marea to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15
SAN FRANCISCO--(BUSINESS WIRE)--Marea Therapeutics, Inc., a clinical-stage biotechnology company harnessing the latest advances in human genetics to develop first-in-class, next-generation medicines for cardio-endocrine diseases, today provided an update on the company’s recent progress and upcoming milestones for 2025 in advance of the J.P. Morgan 43rd Annual Healthcare Conference, taking place from January 13-16, 2025 in San Francisco, CA.
“Since our launch in June 2024, Marea has made excellent progress across a number of areas,” said Josh Lehrer, M.D., M.Phil., FACC, chief executive officer of Marea. “Based on positive results from our Phase 2a study that demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides, we are preparing to advance MAR001 into Phase 2b clinical development in the first half of 2025. These data demonstrate the potential of MAR001 to address the untreated lipid and metabolic drivers of cardiovascular disease in high-risk patients. In addition, we announced our second lead pipeline program for the treatment of acromegaly with clinical development expected to initiate in the second half of 2025. Our strong pipeline progress, further fueled by the recent expansion of our management team and board of directors, positions us for an important 2025 as we seek to accelerate a new generation of medicines for cardiometabolic and endocrine diseases.”
Positive Phase 2a Topline Results for MAR001
- MAR001 is a potential first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue.
- The primary objective of Marea’s randomized, double-blind, placebo-controlled Phase 2a clinical trial was to characterize the safety and tolerability of multiple doses of MAR001 in participants with metabolic dysfunction. Secondary objectives were to describe the serum concentration of MAR001 at selected timepoints and to characterize the effect of MAR001 on triglyceride and remnant cholesterol metabolism following 12 weeks of treatment.
- The study enrolled 55 participants with hypertriglyceridemia (fasting TGs ≥150 and ≤499 mg/dL) randomized to MAR001 or placebo (blinded, 2:1 MAR001:Placebo). Ten participants were randomized to the 150 mg MAR001 arm, 17 participants to the 450 mg MAR001 arm, 9 participants to the 300 mg arm, and 19 participants to placebo.
- Topline results showed meaningful reductions in remnant cholesterol and triglycerides. MAR001 at 300mg and 450mg demonstrated approximately 50% placebo-corrected remnant cholesterol lowering in the target population, predicting meaningful clinical benefit.
- MAR001 was generally well tolerated. There have been no deaths or serious adverse events in any arm, and no adverse events leading to study drug discontinuation.
- The company plans on presenting a fuller data set at an upcoming medical meeting.
- Marea expects to initiate a Phase 2b clinical trial with MAR001 in the first half of 2025.
“These clinical data, coupled with the remarkable human genetic validation of ANGPTL4, the target for MAR001, establishes MAR001 as one of the most promising candidates advancing into late-stage development for treating residual cardiovascular risk in the patients who remain at highest risk despite aggressive standard of care therapies,” said Ethan Weiss, M.D., chief scientific officer of Marea.
Second Lead Pipeline Program Announced: MAR002 for the Treatment of Acromegaly
MAR002 is a potential first-in-class anti-growth hormone receptor (GHR) antibody being developed for acromegaly. Acromegaly is a life-shortening disease where much of the morbidity is caused by insulin resistance, lipotoxicity, and cardiovascular events. Current therapies for acromegaly are associated with suboptimal disease control. It is estimated there are more than 30,000 patients with acromegaly in the U.S.
Marea expects to initiate a Phase 1 clinical trial with MAR002 in the second half of 2025.
Other Corporate Highlights
- In June 2024, Marea announced $190 million in combined Series A and B financings.
- Continued to build out senior leadership team; announced the appointments of Ian Clements, Ph.D., as chief financial officer, Rebecca Juliano, Ph.D., as chief development officer, and Max Zeiberg as senior vice president, corporate development.
- Added Robert A. Harrington, M.D., to Board of Directors.
Presentation at the 43rd Annual J.P. Morgan Healthcare Conference
Management will participate in the 43rd Annual J.P Morgan Healthcare Conference. In addition to hosting meetings, management will present an overview of the Company on Wednesday, January 15, at 11:30 a.m. PT in San Francisco.
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 cardio-endocrine diseases. The company’s lead program, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for 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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Katie Engleman, 1AB
katie@1abmedia.com
