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 that the first participant has been enrolled in Marea’s Phase 1 study evaluating MAR002 for the treatment of acromegaly.

Acromegaly is a chronic, rare, systemic disease most often caused by a growth hormone (GH)-secreting pituitary adenoma, leading to the overproduction of insulin-like growth factor 1 (IGF-1) which mediates the characteristic somatic overgrowth and multisystem involvement observed in affected individuals. The primary objective of medical therapy for acromegaly is to normalize IGF-1 levels according to age and sex.

“Dosing our first participant in this Phase 1 study of MAR002 is a critical milestone for Marea Therapeutics and brings us closer to addressing the significant unmet needs of patients with acromegaly,” said Josh Lehrer, M.D., chief executive officer of Marea Therapeutics. “We believe MAR002’s unique properties, including an allosteric mechanism of action, could make it a differentiated and optimal medical therapy for acromegaly, increasing the effectiveness and reducing the burden associated with current therapies.”

The MAR-201 study is a first-in-human (FIH), randomized, blinded, parallel-group, placebo-controlled single ascending dose (SAD) study in healthy men.

Key objectives of the study include:

• Primary Objective: To evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002, assessed by treatment-emergent adverse events (TEAEs), vital signs, physical examinations, safety laboratories, and electrocardiograms (ECGs).
• Secondary Objective: To evaluate the pharmacokinetics (PK) of SC administration of MAR002
• Exploratory Objectives: To evaluate the effect of SC administration of MAR002 on serum IGF-1 levels (pharmacodynamics [PD]/efficacy) and to assess the immunogenicity.

About MAR002

MAR002 is a potent and selective half-life-extended, allosteric, human monoclonal growth hormone receptor antagonist (GHRA) antibody being developed for the treatment of acromegaly. The in vivo PK and 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 in humans. These characteristics support its potential to offer an effective and convenient treatment for patients with acromegaly.

About Acromegaly

Acromegaly is an orphan disease characterized by the excess secretion of growth hormone (GH) from a benign pituitary adenoma. Acromegaly affects approximately 30,000 patients in the U.S. If left untreated, acromegaly is highly morbid, leading to significant comorbidities such as GH-induced insulin resistance and diabetes, and serious cardiovascular pathology. The median lifespan of patients can be shortened by 10 years without effective therapy, and incomplete IGF-1 normalization is associated with increased mortality. Despite its severity, acromegaly is often under or misdiagnosed, with an average time from symptom onset to diagnosis of approximately eight years.

The current treatment paradigm for acromegaly often involves surgery, performed in over 90% of patients, which achieves remission in about 50% of cases, though this can degrade over time. Medical therapy is required for approximately 65% (around 20,000 in the U.S.) of patients during their disease journey. Current medical treatments include somatostatin receptor ligands (SRLs) and growth hormone receptor antagonist (GHRA) pegvisomant. However, most patients do not achieve biochemical control with existing therapies.

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 cardioendocrine diseases. The company’s lead therapy, MAR001, is in Phase 2 clinical development for adults with metabolic dysfunction and high risk for atherosclerotic 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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