Marea Therapeutics has announced positive top line results from its first-in-human Phase I study of MAR002, an allosteric monoclonal antibody targeting the growth hormone receptor (GHR), for the treatment of acromegaly.
The company also detailed key milestones for 2026, including progress on MAR001, a subcutaneous monoclonal antibody designed to block ANGPTL4 for cardiometabolic disorders.
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The Phase I trial was placebo-controlled, blinded, randomised, parallel-group, and enrolled healthy adult male volunteers.
Single-ascending doses of MAR002 showed a favourable tolerability and safety profile with no drug-related safety signals observed.
Treatment resulted in dose-dependent reductions in circulating growth factor-1 (IGF-1), with peak suppression reached 52% at the highest dose and more than 45% suppression lasting out to 43 days. In comparison, the current GHR antagonist achieves a maximum 48% suppression lasting five days.
These findings validate that MAR002 engages its intended target and demonstrates proof-of-mechanism, with pharmacokinetic (PK) data indicating suitability for dosing every two weeks or monthly.
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By GlobalDataFor MAR001, completion of enrolment in the Phase IIb TYDAL-TIMI 78 study is expected by January 2026. Top line 12-week data are due mid-2026, with 24-four-week data anticipated later in the year.
A Phase II mechanistic study of MAR001 will conclude enrolment by January 2026; results are expected in the second half of 2026.
Marea is advancing a half-life-extended version, MAR001-HLE, planning a single-dose Phase I PK study in healthy volunteers for 2026 and targeting an investigational new drug (IND) filing that year.
A small interfering ribonucleic acid (siRNA) preclinical programme targeting ANGPTL4 aims for development candidate nomination in 2026.
Marea Therapeutics CEO Josh Lehrer said: “The MAR002 data provide clear proof-of-mechanism and underscore our ability to translate human genetic insights into highly differentiated clinical candidates.
“With MAR002 moving toward a registrational study, MAR001 nearing a major Phase IIb 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.”
In August 2025, Marea enrolled the first patient in the Phase I MAR-201 trial evaluating the human monoclonal growth hormone receptor antagonist antibody, MAR002, to treat acromegaly.
