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Business Wire
4 days ago
- 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.
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
07-05-2025
- Health
- Yahoo
Marea Therapeutics Presents Positive Data from Phase 2a Clinical Trial of MAR001, Being Developed for Cardiovascular Disease, in Late-Breaking Oral Session at the 93rd EAS Congress
MAR001, a first-in-class monoclonal antibody targeting ANGPTL4, demonstrated approximately 53% placebo-adjusted mean reduction in remnant cholesterol and placebo-adjusted mean reduction in triglycerides at 12 weeks Approximately 65% placebo-adjusted mean reduction in remnant cholesterol and triglycerides in participants with greater triglyceride elevation at baseline (≥200 mg/dl) MAR001 was generally well tolerated; Phase 2b study expected to initiate in second quarter of 2025 Second oral presentation at EAS describes association of remnant cholesterol levels with major cardiovascular events in patients with atherosclerotic cardiovascular disease, underscoring potential of MAR001 to become an important new therapeutic option SOUTH SAN FRANCISCO, Calif., May 07, 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 presented positive data from a Phase 2a clinical trial of MAR001 in a late-breaking oral session at the 93rd European Atherosclerosis Society (EAS) Congress being held May 4-7, 2025 in Glasgow, UK. MAR001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. "We are very excited by these data from our Phase 2a study, which demonstrate the strong potential of MAR001 to address the most important unaddressed lipid and metabolic drivers of atherosclerotic cardiovascular disease in high-risk patients," said Josh Lehrer, M.D., FACC, chief executive officer of Marea. "We look forward to advancing MAR001 into Phase 2b development for treating residual cardiovascular risk in patients who remain at highest risk despite aggressive standard of care therapies." "Atherosclerotic cardiovascular disease patients with elevated remnant cholesterol remain at an increased risk for major adverse cardiovascular events despite best available standard of care therapies," said Ethan Weiss, M.D., chief scientific officer of Marea. "These data clearly validate the ability of MAR001 to significantly lower remnant cholesterol and triglycerides by inhibiting ANGPTL4, supporting genetic findings and expected translation to substantial cardiovascular disease risk reduction. We believe MAR001 has the potential to become an important new therapeutic option for patients." Presentation Highlights:
Business Wire
07-05-2025
- Health
- Business Wire
Marea Therapeutics Presents Positive Data from Phase 2a Clinical Trial of MAR001, Being Developed for Cardiovascular Disease, in Late-Breaking Oral Session at the 93
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 presented positive data from a Phase 2a clinical trial of MAR001 in a late-breaking oral session at the 93rd European Atherosclerosis Society (EAS) Congress being held May 4-7, 2025 in Glasgow, UK. MAR001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. 'We are very excited by these data from our Phase 2a study, which demonstrate the strong potential of MAR001 to address the most important unaddressed lipid and metabolic drivers of atherosclerotic cardiovascular disease in high-risk patients,' said Josh Lehrer, M.D., FACC, chief executive officer of Marea. 'We look forward to advancing MAR001 into Phase 2b development for treating residual cardiovascular risk in patients who remain at highest risk despite aggressive standard of care therapies.' 'Atherosclerotic cardiovascular disease patients with elevated remnant cholesterol remain at an increased risk for major adverse cardiovascular events despite best available standard of care therapies,' said Ethan Weiss, M.D., chief scientific officer of Marea. 'These data clearly validate the ability of MAR001 to significantly lower remnant cholesterol and triglycerides by inhibiting ANGPTL4, supporting genetic findings and expected translation to substantial cardiovascular disease risk reduction. We believe MAR001 has the potential to become an important new therapeutic option for patients.' Presentation Highlights: The primary objective of Marea's randomized, double-blind, placebo-controlled Phase 2a clinical trial was to characterize the safety and tolerability of multiple doses of MAR001 in participants with elevated triglycerides and remnant cholesterol. Secondary objectives were to describe the serum concentration of MAR001 at selected timepoints and to characterize the effect of MAR001 on triglyceride and remnant cholesterol metabolism following 12 weeks of treatment. The study enrolled 55 participants with hypertriglyceridemia (fasting TGs ≥151 and ≤496 mg/dL) randomized to Q2W MAR001 or placebo (blinded, 2:1 MAR001:Placebo). Ten participants were randomized to the 150 mg MAR001 arm, nine to the 300 mg MAR001 arm, 17 to the 450 mg MAR001 arm, and 19 to placebo. MAR001 demonstrated up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in triglycerides at 12 weeks. In participants with significantly elevated triglyceride levels at baseline (≥200 mg/dL), MAR001 demonstrated up to a 66.0% placebo-adjusted mean reduction in remnant cholesterol and up to a 64.0% placebo-adjusted mean reduction in triglycerides at Week 12. MAR001 was generally well tolerated, with no clinically significant findings, and no findings of elevated systemic inflammatory biomarkers or changes in mesenteric lymph node (MLN) size or local inflammation as assessed by MRI. There were no deaths or serious adverse events in any arm, and no adverse events with MAR001 leading to study drug discontinuation. Table 1: Mean Placebo-Adjusted Reductions in Remnant Cholesterol and Triglyceride (TG) at 12 Weeks Presentation Details: Title: A Novel ANGPTL4 Inhibitory Antibody Safely Lowers Plasma Triglycerides and Remnant Cholesterol in Humans Abstract Number: 1320 Session Title: Late Breaker Session: Clinical Session Date and Time: Wednesday, May 7, 2025, 11:00 a.m. – 12:30 p.m. BST Title: Real-world Analysis of the Association of Remnant Cholesterol Levels with Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease Abstract Number: 1314 Session Title: SaaG Session: Epidemiology: From Prevention to Prognosis Session Date and Time: Tuesday, May 6, 2025, 2:35 p.m. – 3:35 p.m. BST About Remnant Cholesterol Remnant cholesterol is carried by triglyceride-rich lipoproteins, is highly atherogenic, and drives cardiovascular events independent of classical risk factors like LDL cholesterol, diabetes or obesity. There are currently no available targeted therapies to lower remnant cholesterol and improve metabolic function. About MAR001 MAR001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. By inhibiting ANGPTL4 and thereby augmenting lipoprotein lipase (LPL) activity, MAR001 is designed to lower remnant cholesterol and improve adipose tissue function. Human genetic data has identified ANGPTL4 as a highly promising therapeutic target because loss of function alleles leads to lower remnant cholesterol, improved adipose distribution, improved insulin sensitivity, lower triglyceride levels, and protection from cardiovascular disease and type 2 diabetes. MAR001 is being developed to reduce the risk of major adverse cardiovascular events (MACE) in adults with established atherosclerotic cardiovascular disease (ASCVD) plus elevated triglycerides and remnant cholesterol. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. Results from a Phase 2a study of MAR001 demonstrated clinically meaningful reductions in remnant cholesterol and triglycerides. Marea plans to advance MAR001 into Phase 2b clinical development in the second quarter of 2025. 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 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.
