Latest news with #MAR001
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
16-05-2025
- Business
- Yahoo
Marea Therapeutics Announces Publication in The Lancet of Positive Data from Phase 2a Clinical Trial of MAR001 for Cardiovascular Disease
Publication follows late-breaking oral presentation of Phase 2a results at the 93rd EAS Congress; MAR001 demonstrated approximately 53% placebo-adjusted mean reductions in remnant cholesterol and triglycerides at 12 weeks Second publication of MAR001 preclinical results in eBioMedicine that demonstrate improved plasma lipid profiles SOUTH SAN FRANCISCO, Calif., May 16, 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 positive results from a Phase 2a clinical trial of MAR001 were published in The Lancet entitled "Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies." The publication follows a recent late-breaking oral presentation of the Phase 2a results at the 93rd EAS Congress and can be accessed here. In addition, Marea announced a publication of MAR001 preclinical results in the peer-reviewed journal eBioMedicine entitled "A Novel ANGPTL4 Inhibitory Antibody Safely Improves Lipid Profiles in Non-Human Primates." The publication can be accessed here. MAR001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. Results from Marea's Phase 2a clinical trial of MAR001 demonstrated approximately 53% placebo-adjusted mean reductions in remnant cholesterol and triglycerides at 12 weeks with a favorable safety profile. "We are excited to have our MAR001 Phase 2a clinical results and preclinical data recognized within the broader scientific community through these publications in The Lancet and eBioMedicine," said Ethan Weiss, M.D., chief scientific officer of Marea. "These findings validate ANGPTL4 inhibition and the ability of MAR001 to safely and effectively reduce remnant cholesterol and triglycerides, which align with genetic findings and support further development in addressing atherosclerotic cardiovascular disease risk. We look forward to initiating a Phase 2b trial of MAR001 in the second quarter of 2025." 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 lead 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. View source version on Contacts Media Contact:Katie Engleman, 1ABkatie@
Business Wire
16-05-2025
- Business
- Business Wire
Marea Therapeutics Announces Publication in The Lancet of Positive Data from Phase 2a Clinical Trial of MAR001 for Cardiovascular Disease
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 positive results from a Phase 2a clinical trial of MAR001 were published in The Lancet entitled 'Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies.' The publication follows a recent late-breaking oral presentation of the Phase 2a results at the 93rd EAS Congress and can be accessed here. In addition, Marea announced a publication of MAR001 preclinical results in the peer-reviewed journal eBioMedicine entitled 'A Novel ANGPTL4 Inhibitory Antibody Safely Improves Lipid Profiles in Non-Human Primates.' The publication can be accessed here. MAR001 is a first-in-class monoclonal antibody that targets ANGPTL4, a protein that is highly expressed in adipose tissue. Results from Marea's Phase 2a clinical trial of MAR001 demonstrated approximately 53% placebo-adjusted mean reductions in remnant cholesterol and triglycerides at 12 weeks with a favorable safety profile. 'We are excited to have our MAR001 Phase 2a clinical results and preclinical data recognized within the broader scientific community through these publications in The Lancet and eBioMedicine,' said Ethan Weiss, M.D., chief scientific officer of Marea. 'These findings validate ANGPTL4 inhibition and the ability of MAR001 to safely and effectively reduce remnant cholesterol and triglycerides, which align with genetic findings and support further development in addressing atherosclerotic cardiovascular disease risk. We look forward to initiating a Phase 2b trial of MAR001 in the second quarter of 2025.' 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 lead 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.
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:
