Company provides 2026 corporate outlook highlighting multiple clinical catalysts across first-in-class cardioendocrine pipeline
MAR002 Phase 1 Data: Robust, durable IGF-1 suppression supports potential for biweekly to monthly dosing; Phase 2/3 study initiation expected mid-2026
MAR001 Phase 2b TYDAL-TIMI 78 Study Enrollment Nearing Completion: multiple data readouts expected throughout 2026; advancing half-life-extended MAR001-HLE designed for infrequent, low-volume subcutaneous dosing toward Phase 3 readiness
Pipeline Expansion: Advancing next-generation siRNA portfolio with development candidate nomination(s) expected in 2026
Management to present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, at 10:30 a.m. PT
South San Francisco, Calif., January 13, 2026 – 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 positive topline results from its first-in-human Phase 1 study of MAR002, a first-in-class allosteric monoclonal antibody targeting the growth hormone receptor (GHR) for the treatment of acromegaly. The company also highlighted key pipeline milestones expected in 2026 – including for its lead cardiometabolic program, MAR001, a first-in-class, subcutaneously delivered monoclonal antibody designed to block the activity of ANGPTL4, a genetically validated driver of remnant cholesterol and atherosclerotic cardiovascular disease (ASCVD) risk.
“The MAR002 data provide clear proof-of-mechanism and underscore our ability to translate human genetic insights into highly differentiated clinical candidates,” said Josh Lehrer, M.D., chief executive officer of Marea Therapeutics. “With MAR002 moving toward a registrational study, MAR001 nearing a major Phase 2b readout, and our siRNA platform expanding, Marea is uniquely positioned to redefine the treatment of cardioendocrine diseases. 2026 will be a catalyst-rich year as we execute across our entire portfolio.”
MAR002: Phase 1 Data Demonstrate Proof-of-Mechanism and Support Best-in-Disease Potential
- The first-in-human, randomized, blinded, parallel-group, placebo-controlled Phase 1 study enrolled healthy adult male volunteers and single ascending doses of MAR002 demonstrated a favorable safety and tolerability profile, with no drug-related safety signals observed.
- Treatment with MAR002 resulted in robust and durable dose-dependent reductions in circulating insulin-like growth factor-1 (IGF-1) with peak suppression of 52% (+/- 5.4%) occurring at the highest dose tested and greater than 45% suppression out to 43 days. This is compared to a maximum suppression of 48% (+/- 7%) and greater than 45% suppression lasting to only 5 days with the current commercially available GHR antagonist.
- Overall, these data confirm target engagement and proof-of-mechanism with pharmacokinetics (PK) supporting bi-weekly to monthly dosing.
“IGF-1 normalization is a validated biomarker and primary regulatory endpoint in acromegaly, and reductions observed in healthy volunteers have historically been highly predictive of clinical efficacy in patients,” said Rebecca Juliano, Ph.D., chief development officer of Marea Therapeutics. “Acromegaly affects more than 30,000 patients in the U.S., and fewer than 40% of patients achieve adequate disease control with current first-line somatostatin receptor ligands. MAR002 is designed to directly block growth hormone signaling at the receptor level and has the potential to achieve biochemical control in the vast majority of patients, positioning it as a potential best-in-disease therapy with convenient biweekly to monthly dosing. These Phase 1 data provide strong proof-of-mechanism for MAR002 and we look forward to initiating a Phase 2/3 clinical study of MAR002 in patients with acromegaly in mid-2026.”