Latest news with #MareaTherapeutics
Yahoo
12-08-2025
- Health
- Yahoo
Marea Therapeutics Enrolls First Participant in Phase 1 Clinical Study Evaluating MAR002 for Acromegaly
SOUTH SAN FRANCISCO, Calif., August 12, 2025--(BUSINESS WIRE)--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 and follow us on LinkedIn and X. View source version on Contacts Media:1ABKatie Englemankatie@ Investors:Meru AdvisorsLauren Glaserlglaser@ Sign in to access your portfolio
Business Wire
12-08-2025
- Health
- Business Wire
Marea Therapeutics Enrolls First Participant in Phase 1 Clinical Study Evaluating MAR002 for Acromegaly
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 and follow us on LinkedIn and X.
Yahoo
04-08-2025
- Business
- Yahoo
Marea Therapeutics Enrolls First Patient in Phase 2b TYDAL-TIMI 78 Clinical Study Evaluating MAR001 in Adults at Risk of ASCVD
SOUTH SAN FRANCISCO, Calif., August 04, 2025--(BUSINESS WIRE)--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 patient has been enrolled in Marea's Phase 2b TYDAL-TIMI 78 study evaluating MAR001 in adults with elevated levels of triglycerides (TG) and remnant cholesterol (RC) at increased risk of atherosclerotic cardiovascular disease (ASCVD). MAR001 is a monoclonal antibody delivered by subcutaneous injection that is designed to block the activity of ANGPTL4, a protein that is highly expressed in adipose tissue. MAR001 is being developed to address unmet risk in patients with ASCVD and persistently elevated levels of TG and RC. The Phase 2b TYDAL-TIMI 78 study aims to enroll approximately 216 patients who will be randomized in a 3:1 ratio to receive MAR001 or placebo every four weeks for 24 weeks. Patients in the MAR001 arms will be randomized to receive 300mg, 450mg or 900mg. The primary endpoints will evaluate the percent change from baseline at week 12 in fasting TGs and fasting RC as compared with placebo. Safety and tolerability will be assessed, and secondary endpoints include changes in fasting very low-density lipoprotein cholesterol (VLDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). "Despite significant progress in managing cardiovascular risk, many patients continue to face elevated risk due to high levels of remnant cholesterol carried on triglyceride-rich lipoproteins. The TYDAL-TIMI 78 study offers an important opportunity to explore the therapeutic potential of MAR001, a genetically informed and promising approach to targeting ANGPTL4," said Marc S. Sabatine, M.D., M.P.H., chairman of the thrombolysis in myocardial infarction (TIMI) study group and TYDAL study chair. "By addressing a major unmet need with a novel mechanism, this trial could pave the way for a new class of therapies to reduce residual risk in patients with cardiometabolic disease. We're pleased to lead this important study and look forward to evaluating MAR001's impact on meaningful lipid parameters and overall cardiovascular health." "The initiation of the TYDAL study marks an important milestone for Marea and for patients at risk of atherosclerotic cardiovascular disease," said Josh Lehrer, M.D., chief executive officer of Marea. "MAR001 is a first-in-class, genetically validated investigational therapy with the potential to improve outcomes by reducing remnant cholesterol and triglycerides - two critical and under-addressed drivers of residual cardiovascular risk. We're advancing MAR001 into a Phase 2b trial and aim to generate data that could shift the treatment paradigm in cardiometabolic disease. MAR001 may offer precision therapy for patients with elevated residual risk despite control of traditional factors. We expect topline TYDAL results in mid-2026 and are energized to move this innovative therapy closer to the patient." About MAR001 MAR001 is a monoclonal antibody designed to block the activity of ANGPTL4. MAR001 binds with high affinity to the N-terminal coiled-coil domain of ANGPTL4. Given the enrichment in expression of ANGPTL4 in adipose tissue, MAR001 leads to augmented hydrolysis of triglyceride (TG) rich lipoproteins and optimal storage of TGs, and both nonclinical and clinical studies have demonstrated significant reductions in TG and remnant cholesterol (RC), the cholesterol carried on TG-rich lipoproteins. Substantial reductions in TG and RC are predicted to reduce atherosclerotic cardiovascular disease (ASCVD) risk. 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 and follow us on LinkedIn and X. View source version on Contacts Media:1ABKatie Englemankatie@ Investors:Meru AdvisorsLauren Glaserlglaser@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
04-08-2025
- Health
- Business Wire
Marea Therapeutics Enrolls First Patient in Phase 2b TYDAL-TIMI 78 Clinical Study Evaluating MAR001 in Adults at Risk of ASCVD
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 patient has been enrolled in Marea's Phase 2b TYDAL-TIMI 78 study evaluating MAR001 in adults with elevated levels of triglycerides (TG) and remnant cholesterol (RC) at increased risk of atherosclerotic cardiovascular disease (ASCVD). MAR001 is a monoclonal antibody delivered by subcutaneous injection that is designed to block the activity of ANGPTL4, a protein that is highly expressed in adipose tissue. MAR001 is being developed to address unmet risk in patients with ASCVD and persistently elevated levels of TG and RC. The Phase 2b TYDAL-TIMI 78 study aims to enroll approximately 216 patients who will be randomized in a 3:1 ratio to receive MAR001 or placebo every four weeks for 24 weeks. Patients in the MAR001 arms will be randomized to receive 300mg, 450mg or 900mg. The primary endpoints will evaluate the percent change from baseline at week 12 in fasting TGs and fasting RC as compared with placebo. Safety and tolerability will be assessed, and secondary endpoints include changes in fasting very low-density lipoprotein cholesterol (VLDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C). "Despite significant progress in managing cardiovascular risk, many patients continue to face elevated risk due to high levels of remnant cholesterol carried on triglyceride-rich lipoproteins. The TYDAL-TIMI 78 study offers an important opportunity to explore the therapeutic potential of MAR001, a genetically informed and promising approach to targeting ANGPTL4,' said Marc S. Sabatine, M.D., M.P.H., chairman of the thrombolysis in myocardial infarction (TIMI) study group and TYDAL study chair. 'By addressing a major unmet need with a novel mechanism, this trial could pave the way for a new class of therapies to reduce residual risk in patients with cardiometabolic disease. We're pleased to lead this important study and look forward to evaluating MAR001's impact on meaningful lipid parameters and overall cardiovascular health.' 'The initiation of the TYDAL study marks an important milestone for Marea and for patients at risk of atherosclerotic cardiovascular disease,' said Josh Lehrer, M.D., chief executive officer of Marea. 'MAR001 is a first-in-class, genetically validated investigational therapy with the potential to improve outcomes by reducing remnant cholesterol and triglycerides - two critical and under-addressed drivers of residual cardiovascular risk. We're advancing MAR001 into a Phase 2b trial and aim to generate data that could shift the treatment paradigm in cardiometabolic disease. MAR001 may offer precision therapy for patients with elevated residual risk despite control of traditional factors. We expect topline TYDAL results in mid-2026 and are energized to move this innovative therapy closer to the patient.' About MAR001 MAR001 is a monoclonal antibody designed to block the activity of ANGPTL4. MAR001 binds with high affinity to the N-terminal coiled-coil domain of ANGPTL4. Given the enrichment in expression of ANGPTL4 in adipose tissue, MAR001 leads to augmented hydrolysis of triglyceride (TG) rich lipoproteins and optimal storage of TGs, and both nonclinical and clinical studies have demonstrated significant reductions in TG and remnant cholesterol (RC), the cholesterol carried on TG-rich lipoproteins. Substantial reductions in TG and RC are predicted to reduce atherosclerotic cardiovascular disease (ASCVD) risk. 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 and follow us on LinkedIn and X.
Yahoo
14-07-2025
- Business
- Yahoo
Marea Therapeutics Presents Preclinical Data on Novel Growth Hormone Receptor Antagonist Antibody, MAR002, for the Treatment of Acromegaly at ENDO 2025
SOUTH SAN FRANCISCO, Calif., July 14, 2025--(BUSINESS WIRE)--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 and follow us on LinkedIn and X. View source version on Contacts Media:1ABKatie Englemankatie@ Investors:Meru AdvisorsLauren Glaserlglaser@ Sign in to access your portfolio
