Marea Therapeutics Presents Phase 1 Data for MAR002, a First-in-Class GHR Antibody, Showing Up to 64% IGF-1 Suppression in Acromegaly at ENDO 2026
核心洞察
MAR002, a first-in-class allosteric monoclonal antibody targeting the growth hormone receptor (搜索), demonstrated up to 64% IGF-1 suppression in a first-in-human Phase 1 study presented at ENDO 2026.
The pharmacokinetic profile supports once every two-week dosing, a significant convenience advantage over the daily injections required by the current standard of care pegvisomant.
Fewer than 35% of acromegaly (搜索) patients achieve optimal disease control on first-line medical therapy, highlighting substantial unmet need that MAR002 may address.
MAR002, a first-in-class allosteric monoclonal antibody targeting the growth hormone receptor (搜索) (GHR), demonstrated deep and durable suppression of insulin-like growth factor-1 (IGF-1) of up to 64% in a first-in-human Phase 1 study, according to data presented by Marea Therapeutics (搜索) at the 2026 Annual Meeting of the Endocrine Society (ENDO) in Chicago. The findings support a potential best-in-disease profile and position MAR002 as a significant advancement for patients with acromegaly (搜索), a rare endocrine disorder with substantial unmet medical need.
"The Phase 1 data presented at ENDO provide compelling proof-of-mechanism for MAR002 and strengthen our confidence as we advance into a Phase 2/3 study in patients with acromegaly (搜索) expected to begin in the coming weeks," said Rebecca Juliano, Ph.D., chief development officer of Marea Therapeutics (搜索).
Phase 1 Study Results and Pharmacokinetic Profile
The first-in-human study evaluated MAR002 in healthy men and demonstrated translational potential for acromegaly (搜索). The data showed that MAR002 produced deep and durable IGF-1 suppression, with reductions reaching up to 64%. IGF-1 is a validated biomarker and regulatory endpoint in acromegaly, making these results particularly meaningful for establishing clinical efficacy.
The pharmacokinetic (PK) and pharmacodynamic (PD) properties of MAR002 are predictable and typical of a half-life extended human antibody, showing a long duration of action compatible with infrequent subcutaneous dose administration. These characteristics may enable dosing as infrequently as once every two weeks, compared to the daily subcutaneous injections required by the current standard of care.
"MAR002 demonstrated deep and durable suppression of IGF-1, a validated biomarker and regulatory endpoint in acromegaly (搜索), while exhibiting pharmacokinetic properties that may support convenient dosing as infrequently as every two weeks," Juliano added. "By directly blocking growth hormone signaling at the receptor level, MAR002 has the potential to deliver meaningful biochemical control for a broad population of patients and establish a new standard of care in acromegaly."
Unmet Need in Acromegaly (搜索)
Acromegaly (搜索) is a rare, chronic, progressive endocrine disorder caused by prolonged exposure to excess growth hormone (GH), most commonly due to a GH-secreting pituitary adenoma, resulting in elevated IGF-1 levels. The condition leads to abnormal enlargement of the hands, feet, and facial features, and if left untreated, can result in severe systemic complications.
Current treatment options remain suboptimal for many patients. "Acromegaly (搜索) remains a disorder of significant unmet need, with fewer than 35% of patients achieving optimal disease control on first-line medical therapy," said Shlomo Melmed, M.D., Distinguished Professor and Dean at Cedars-Sinai.
GH receptor antagonists offer therapeutic advantages by directly blocking GH signaling, lowering IGF-1, and improving insulin sensitivity. However, the only approved GHRA, pegvisomant, requires daily administration, resulting in suboptimal patient adherence and reduced real-world efficacy.
Expert Perspective on MAR002's Potential
Dr. Melmed highlighted the significance of the early findings: "The depth of initial IGF-1 suppression reported with MAR002 of up to 64% is particularly notable, as it appears to exceed levels seen with previously reported therapies in acromegaly (搜索). Based on these early findings, and if proven safe, MAR002 has the potential to become a significant advancement in both efficacy and treatment convenience for patients with acromegaly."
Next Steps: Phase 2/3 Study
Marea Therapeutics (搜索) remains on track to initiate a Phase 2/3 study of MAR002 in acromegaly (搜索) in mid-2026. The company is also advancing MAR001, a therapy in Phase 2b clinical development for the treatment of severe hypertriglyceridemia (搜索) (sHTG).
The oral presentation, titled "A First-in-Human Study of a Novel Growth Hormone Receptor (搜索) Antagonist Antibody in Healthy Men Demonstrates Translational Potential for Acromegaly (搜索)" (ORF28-08), was delivered on June 14, 2026, during the Neuroendocrinology and Pituitary session at ENDO 2026.