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
'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., M.Phil., 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 www.mareatx.com and follow us on LinkedIn and X.
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We use Adjusted EBITDA, Adjusted EBITDA margin, and Free Cash Flow to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that Adjusted EBITDA, Adjusted EBITDA margin, and Free Cash Flow, when taken together with the corresponding U.S. GAAP financial measures, provide meaningful supplemental information regarding our performance by excluding certain items that may not be indicative of our business, results of operations, or outlook. We consider Adjusted EBITDA, Adjusted EBITDA margin, and Free Cash Flow to be important measures because they help illustrate underlying trends in our business and our historical operating performance on a more consistent basis. We believe that the use of Adjusted EBITDA, Adjusted EBITDA margin, and Free Cash Flow is helpful to our investors as they are used by management in assessing the health of our business, our operating performance, and our liquidity. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. In addition, other companies, including companies in our industry, may calculate similarly-titled non-GAAP financial measures or ratios differently or may use other financial measures or ratios to evaluate their performance, all of which could reduce the usefulness of Adjusted EBITDA, Adjusted EBITDA margin, and Free Cash Flow as tools for comparison. Reconciliations are provided below to the most directly comparable financial measures stated in accordance with U.S. GAAP. Investors are encouraged to review our U.S. GAAP financial measures and not to rely on any single financial measure to evaluate our business. Adjusted EBITDA is a key performance measure that our management uses to assess our operating performance. Because Adjusted EBITDA facilitates internal comparisons of our historical operating performance on a more consistent basis, we use this measure for business planning purposes. 'Adjusted EBITDA' is defined as net income before stock-based compensation, depreciation and amortization, acquisition and transaction-related costs (which includes (i) consideration paid for employee and nonemployee compensation with vesting requirements incurred directly as a result of acquisitions, and (ii) transaction professional services), payroll tax expense related to stock-based compensation, impairment of long-lived assets, interest income and expense, net, and income taxes. 'Adjusted EBITDA margin' is defined as Adjusted EBITDA divided by revenue. In the second quarter of 2025, we revised our definition of Adjusted EBITDA to include payroll tax expense related to stock-based compensation, which comprises employer taxes incurred upon vesting of restricted stock units and upon exercise of nonqualified stock options. As a result of recent trends in our stock price, this amount was not considered significant for prior periods and, accordingly, prior period disclosures were not recast to conform to the current presentation. Some of the limitations of Adjusted EBITDA include (i) Adjusted EBITDA does not properly reflect capital commitments to be paid in the future, and (ii) although depreciation and amortization are non-cash charges, the underlying assets may need to be replaced and Adjusted EBITDA does not reflect these capital expenditures. In evaluating Adjusted EBITDA, you should be aware that in the future we will incur expenses similar to the adjustments in this presentation. Our presentation of Adjusted EBITDA should not be construed as an inference that our future results will be unaffected by these expenses or any unusual or non-recurring items. We compensate for these limitations by providing specific information regarding the U.S. GAAP items excluded from Adjusted EBITDA. When evaluating our performance, you should consider Adjusted EBITDA in addition to, and not as a substitute for, other financial performance measures, including our net income and other U.S. GAAP results. Free Cash Flow is a key performance measure that our management uses to assess our liquidity. Because Free Cash Flow facilitates internal comparisons of our historical liquidity on a more consistent basis, we use this measure for business planning purposes. 'Free Cash Flow' is defined as net cash (used in) provided by operating activities, less purchases of property, equipment, and intangible assets and investment in website development and internal-use software in investing activities. Some of the limitations of Free Cash Flow include (i) Free Cash Flow does not represent our residual cash flow for discretionary expenditures and our non-discretionary commitments, and (ii) Free Cash Flow includes capital expenditures, the benefits of which may be realized in periods subsequent to those in which the expenditures took place. In evaluating Free Cash Flow, you should be aware that in the future we will have cash outflows similar to the adjustments in this presentation. Our presentation of Free Cash Flow should not be construed as an inference that our future results will be unaffected by these cash outflows or any unusual or non-recurring items. When evaluating our performance, you should consider Free Cash Flow in addition to, and not as a substitute for, other financial performance measures, including our net cash (used in) provided by operating activities and other U.S. GAAP results.
Business Wire
7 hours ago
- Business Wire
Diversified Healthcare Trust Announces Second Quarter 2025 Results
NEWTON, Mass.--(BUSINESS WIRE)--Diversified Healthcare Trust (Nasdaq: DHC) today announced its financial results for the quarter ended June 30, 2025, which can be found at the Quarterly Reports section of DHC's website at A conference call to discuss DHC's second quarter 2025 financial results will be held on Tuesday, August 5, 2025 at 10:00 a.m. Eastern Time. The conference call may be accessed by dialing (877) 329-4297 or (412) 317-5435 (if calling from outside the United States and Canada); a pass code is not required. A replay will be available for one week by dialing (877) 344-7529; the replay pass code is 1592130. A live audio webcast of the conference call will also be available in a listen-only mode on DHC's website, at The archived webcast will be available for replay on DHC's website after the call. The transcription, recording and retransmission in any way of DHC's second quarter conference call are strictly prohibited without the prior written consent of DHC. About Diversified Healthcare Trust: DHC is a real estate investment trust focused on owning high-quality healthcare properties located throughout the United States. DHC seeks diversification across the health services spectrum by care delivery and practice type, by scientific research disciplines and by property type and location. As of June 30, 2025, DHC's approximately $6.8 billion portfolio included 341 properties in 34 states and Washington, D.C., with more than 26,000 senior living units, approximately 7.4 million square feet of medical office and life science properties and occupied by approximately 450 tenants. DHC is managed by The RMR Group (Nasdaq: RMR), a leading U.S. alternative asset management company with approximately $40 billion in assets under management as of June 30, 2025 and more than 35 years of institutional experience in buying, selling, financing and operating commercial real estate. DHC is headquartered in Newton, MA. For more information, visit A Maryland Real Estate Investment Trust with transferable shares of beneficial interest listed on the Nasdaq. No shareholder, Trustee or officer is personally liable for any act or obligation of the Trust.
