Trial follows promising MAR002 Phase 1 clinical trial results that demonstrated deep and durable IGF-1 suppression with PK properties that may enable dosing as infrequently as once every two weeks, compared to the daily subcutaneous injections required by the current standard of care
By directly blocking growth hormone signaling at the receptor level, MAR002 has the potential to deliver meaningful biochemical control for a broad population of acromegaly patients
SOUTH SAN FRANCISCO, Calif. and LIBERTY CORNER, N.J., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Marea Therapeutics, LLC (“Marea”), a subsidiary of Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), 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 first patient has been dosed in its Phase 2 clinical trial of MAR002 for the treatment of acromegaly.
Acromegaly 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 insulin-like growth factor-1 (IGF-1). It leads to the abnormal enlargement of the hands, feet, and facial features, and if left untreated, can result in severe organ damage, systemic complications, and early mortality.
MAR002 is a first-in-class allosteric monoclonal antibody investigational therapy targeting the growth hormone receptor (GHR). Data from a first-in-human Phase 1 study with MAR002 presented at the 2026 Annual Meeting of the Endocrine Society (ENDO) in June 2026 demonstrated compelling proof-of-mechanism with deep and durable IGF-1 suppression and pharmacokinetic (PK) properties that may enable dosing as infrequently as once every two weeks, compared to the daily subcutaneous injections required by the current standard of care.
“Treating our first acromegaly patient with MAR002 represents an important milestone for Marea Therapeutics,” said Josh Lehrer, M.D., president and chief operating officer of Lisata Therapeutics and chief executive officer of Marea Therapeutics. “We believe MAR002 has a potential best-in-class profile and, if approved, could be transformative for the majority of acromegaly patients who cannot achieve disease control with current therapies. We are focused on clinical execution to rapidly advance this product candidate to acromegaly patients who need new treatment options.”
“People living with acromegaly often face years of symptoms before receiving a diagnosis, and even after diagnosis, many continue to struggle with the long-term burden of managing this chronic disease,” said Jill Sisco, president of Acromegaly Community, Inc. “The advancement of new treatment options that have the potential to provide effective disease control while reducing treatment burden offers hope for the acromegaly community. We are encouraged to see continued investment in investigational therapies like MAR002 that aim to address the needs and priorities of people living with this condition and expand treatment options.”
This study intends to enroll approximately 72 participants with acromegaly across three MAR002 dose arms, after an initial 900 mg loading dose, compared to placebo, with a primary endpoint of IGF-1 reduction following 10 weeks of treatment. After completing the 10-week treatment period, eligible participants will have an option to enroll in an open-label extension clinical trial.
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.
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 have been observed to be 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, if approved.
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 product candidate, MAR001, is in Phase 2b clinical development for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels. The company is also advancing MAR002 in Phase 2 clinical development for the treatment of acromegaly. To learn more, please visit www.mareatx.com and follow us on LinkedIn and X.
About Lisata Therapeutics
Lisata Therapeutics is a clinical-stage pharmaceutical company. Following its acquisition of Marea, Lisata’s lead product candidate is MAR001, which is in Phase 2b clinical development for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels. The company is also advancing MAR002 for the treatment of acromegaly.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, concerning Lisata and Marea. These forward-looking statements include, but are not limited to, express or implied statements relating to the company’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding expectations regarding or plans for the company’s pipeline, including its ongoing clinical trials, research and development programs and the expected timing for key milestones; and the potential benefits of its product candidates, including MAR002 and MAR001. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “aim,” “strategy,” “target,” “seek,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “predict,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to those uncertainties and factors described under the heading “Risk Factors” in the company’s most recent Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2026, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by the company from time to time, as well as risk factors associated with companies, such as Marea, that operate in the biotechnology industry. Should one or more of these risks or uncertainties materialize, or should any of the company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Except to the extent required by applicable law, the company does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in the company.
Lisata:
Investors and Media:
John Menditto
jmenditto@lisata.com
Marea:
Media:
1AB
Katie Engleman
katie@1abmedia.com
Investors:
Meru Advisors
Lauren Glaser
lglaser@meruadvisors.com
