Pegvisomant

SOUTH SAN FRANCISCO, CA, USA I July 14, 2025 I 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: 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 . SOURCE: Marea Therapeutics

Pictured: Blood sample for insulin-like growth factor-1 (IGF-1)/iStock, Jarun011 Crinetics Pharmaceuticals has secured another late-stage win as its oral, once-daily investigational drug paltusotine aced a second Phase III study for acromegaly, a rare hormonal disorder. The biotech’s stock shot up over 10% Tuesday morning following the announcement. In the late-stage trial, 56% of patients taking paltusotine achieved the primary endpoint for the insulin-like growth factor 1 (IGF-1) level compared to 5% on placebo. The treatment also helped reduce symptoms of the disease—a secondary endpoint of the study. No serious adverse events were reported. Acromegaly, sometimes referred to as gigantism, is a serious hormonal disorder caused by a benign tumor in the pituitary gland that secretes growth hormone. Over 25,000 patients in the U.S. suffer from the rare disease, which results in enlargement of face, hands and feet. Left untreated, it can cause type 2 diabetes, hypertension, heart disease and other serious complications. Surgical removal of the tumor is the preferred treatment but many patients are not candidates for surgery. Current pharmacological options include painful monthly injections or Pfizer’s subcutaneous daily injection of Somavert. The Phase III data are the second positive trial results for Crinetics in acromegaly. In September 2023, the biotech shared data for a study of paltusotine in patients who switched from their current injections to Crinetics’ pill. Among treated patients, 83% were able to maintain their IGF-1 levels within the upper limit of normal, compared to only 4% of those on placebo. With these data in hand, Crinetics plans to submit its New Drug Application to the FDA in the second half of this year, while prepping for a 2025 launch. Jefferies analysts believe the market opportunity could be around $300 million for the company. Crinetics is also testing the drug candidate in carcinoid syndrome, reporting positive Phase II topline results last week. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.