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 the presentation of preclinical data on MAR002, a novel growth hormone receptor (GHR) antagonist antibody for the treatment of acromegaly, at the 2025 Annual Meeting of the Endocrine Society (ENDO).

The oral presentation, titled “Development of a Novel Growth Hormone Receptor Antagonist Antibody for the Treatment of Acromegaly,” highlights the significant potential of MAR002 to address critical unmet needs in patients suffering from this rare and highly morbid disease.

Presentation highlights include:

• Highly potent GHR antagonism: MAR002 is a novel, highly potent antagonist of growth hormone (GH) signaling. It demonstrates superior GHR binding relative to pegvisomant and approximates the affinity of native GH.
• Allosteric mechanism of action: MAR002 does not prevent GH binding to the GHR in vitro and potently antagonizes downstream signaling across a broad range of GH concentrations.
• Superior suppression: MAR002 suppresses GHR signaling in vitro, achieving 93% suppression of human GHR compared to 24% for pegvisomant.
• Enhanced durability: MAR002 exhibited potent and sustained insulin-like growth factor-1 (IGF-1) suppression in vivo in non-human primates (NHPs). Compared head-to-head to pegvisomant, a single dose of MAR002 resulted in a similar maximum IGF-1 suppression, but with a considerably longer duration of effect.

Marea Therapeutics has completed a GLP-toxicology study to assess MAR002's safety. The preclinical pharmacology data strongly support advancing MAR002 into clinical development; a Phase 1 first-in-human study is expected to begin in the third quarter of 2025. Marea’s development strategy aims for rapid advancement into acromegaly patients after achieving proof of mechanism in healthy volunteers, with a clear path to approval guided by FDA guidance for IGF-1 normalization.

“The preclinical data presented at ENDO 2025 underscore the potential of MAR002 to meaningfully transform the treatment landscape for acromegaly,” said Ethan Weiss, M.D., chief scientific officer of Marea Therapeutics. “With its strong potency, enhanced durability, and favorable developability profile, MAR002 is uniquely positioned to overcome the limitations of current therapies and offer a more effective, targeted approach for patients. We are excited to advance MAR002 into clinical development and bring forward a next generation and potential best-in-class GHR antagonist.”

Marea Therapeutics believes MAR002 represents a significant opportunity to replace and expand the market for existing growth hormone receptor antagonists (GHRAs) and could also be used in combination with somatostatin receptor ligands (SRLs), offering a more effective and convenient treatment option for patients with acromegaly.

About MAR002

MAR002 is a novel, potent and selective half-life-extended, allosteric, human monoclonal GHRA antibody being developed for the treatment of acromegaly. The 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, regardless of their surgical history. Current medical treatments include somatostatin receptor ligands (SRLs) and growth hormone receptor antagonists (GHRAs), such as pegvisomant. However, many 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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