Marea Therapeutics has enrolled the first subject in the MAR-201 Phase I trial of the human monoclonal growth hormone receptor antagonist (GHRA) antibody, MAR002, aimed at treating acromegaly.
This chronic and uncommon condition typically occurs due to a growth hormone-secreting pituitary adenoma, resulting in elevated levels of insulin-like growth factor 1 (IGF-1).
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The first-in-human, blinded, randomised, parallel-group, placebo-controlled, single-ascending dose (SAD) trial is being conducted in healthy male participants.
Its primary goal is to evaluate the tolerability and safety of the therapy’s subcutaneous administration.
This will be evaluated through the monitoring of treatment-emergent adverse events, crucial signs, safety laboratories, physical examinations, and electrocardiograms.
Secondary objectives are focused on understanding the pharmacokinetics (PK) of the therapy when administered subcutaneously.
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By GlobalDataAdditionally, exploratory goals include assessing the impact of MAR002 on serum IGF-1 levels, which will provide insights into the pharmacodynamics (PD) and potential efficacy of the treatment, as well as evaluating the immunogenicity.
Marea Therapeutics CEO Josh Lehrer said: “Dosing our first participant in this Phase I study of MAR002 is a critical milestone for Marea Therapeutics and brings us closer to addressing the significant unmet needs of patients with acromegaly.
“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.”
According to the company, the predictable in vivo PD and PK properties of the therapy position it as a potentially convenient treatment option for individuals with acromegaly.
The therapy’s main goal is the normalisation of IGF-1 levels as per sex and age.
The company’s flagship therapy, MAR001, is currently in Phase II clinical development targeting the adult population with metabolic dysfunction and elevated risk for atherosclerotic cardiovascular disease.
