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About NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS)
NewAmsterdam Pharma Company N.V. is a late-stage biopharmaceutical company dedicated to advancing patient care in populations with metabolic and cardiovascular diseases, particularly those inadequately served by current therapies. The company specializes in developing innovative, non-statin, oral therapies to address elevated low-density lipoprotein cholesterol (LDL-C), a critical factor in cardiovascular disease (CVD).
Core Mission and Therapeutic Focus
NewAmsterdam Pharma’s mission is to fill a significant unmet need for safe, well-tolerated, and convenient LDL-lowering therapies. Its flagship product, obicetrapib, is a next-generation, low-dose cholesteryl ester transfer protein (CETP) inhibitor designed to overcome the limitations of existing lipid-lowering treatments. Obicetrapib is being developed as both a monotherapy and as a fixed-dose combination with ezetimibe, offering a once-daily oral solution for patients at heightened risk of cardiovascular events.
Clinical Development and Research
The company’s robust clinical development program includes four pivotal Phase 3 trials involving over 12,250 patients globally:
- BROOKLYN Trial: Focused on patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels remain inadequately controlled despite maximally tolerated lipid-lowering therapy.
- BROADWAY Trial: Evaluated obicetrapib in patients with atherosclerotic cardiovascular disease (ASCVD) and/or HeFH, achieving significant LDL-C reduction and a promising exploratory reduction in major adverse cardiovascular events (MACE).
- TANDEM Trial: Investigated the fixed-dose combination of obicetrapib and ezetimibe, demonstrating clinically meaningful LDL-C reductions with a favorable safety profile.
- PREVAIL Trial: A cardiovascular outcomes trial (CVOT) designed to assess obicetrapib’s potential to reduce major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, and stroke.
In addition to these trials, NewAmsterdam has conducted multiple Phase 2 studies (ROSE, ROSE2, TULIP, OCEAN), all of which demonstrated statistically significant LDL-lowering effects with a side effect profile comparable to placebo.
Competitive Positioning and Market Impact
NewAmsterdam operates in the highly competitive lipid-lowering therapy market, which includes statins, PCSK9 inhibitors, and other non-statin therapies. The company’s differentiation lies in obicetrapib’s ability to achieve meaningful LDL-C reductions in patients who are inadequately served by current options. Its once-daily oral formulation offers a convenient alternative to injectable therapies, potentially improving patient adherence and outcomes.
Through its collaboration with the Menarini Group, NewAmsterdam has secured exclusive commercialization rights for obicetrapib in Europe, ensuring a strong presence in a key geographic market. The company also holds a robust intellectual property portfolio, including a composition of matter patent extending protection for obicetrapib in the United States until 2043.
Significance in Cardiovascular Disease Management
Cardiovascular disease remains the leading cause of death globally, with millions of patients struggling to achieve LDL-C targets despite the availability of high-intensity statins and other therapies. NewAmsterdam’s innovative approach addresses this critical gap, offering new hope for patients with ASCVD, HeFH, and other high-risk conditions.
Conclusion
NewAmsterdam Pharma Company N.V. is at the forefront of transforming cardiovascular care through its pioneering work on LDL-C lowering therapies. With a strong clinical pipeline, strategic partnerships, and a commitment to addressing unmet medical needs, the company is poised to make a significant impact in the biopharmaceutical industry and improve health outcomes for millions worldwide.
NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 BROOKLYN clinical trial for obicetrapib, targeting adult patients with heterozygous familial hypercholesterolemia (HeFH) whose LDL-C levels are inadequately managed despite maximal lipid-lowering therapy. The trial enrolled 354 participants across ten countries, with results expected in the second half of 2024. Obicetrapib, a next-generation CETP inhibitor, aims to offer improved options for HeFH patients. Previous Phase 2 trials showed significant LDL-C reduction of 51% and 59% in combination therapy. The rapid enrollment reflects a pressing unmet need for effective LDL-C management in the HeFH community.
NewAmsterdam Pharma Company (Nasdaq: NAMS) has announced the appointment of Janneke van der Kamp as an independent director on its Board of Directors. Ms. van der Kamp brings over two decades of pharmaceutical experience, particularly in cardiovascular disease. CEO Michael Davidson expressed optimism about her contributions as the company advances its clinical trials for obicetrapib. The company, focused on transforming therapies for metabolic diseases, is preparing for key regulatory milestones, building on promising clinical results showing significant LDL-C reductions with obicetrapib. NewAmsterdam recently completed a business combination with Frazier Lifesciences, raising approximately $328 million.
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) has successfully completed its business combination with FLAC and raised approximately $235 million through an oversubscribed PIPE financing, extending its cash runway through 2026. The company announced positive results from the Phase 2 ROSE2 trial, showing a 59% reduction in LDL-C when obicetrapib was combined with ezetimibe, and is set to present full data at the NLA Scientific Sessions in June 2023. Additionally, NewAmsterdam has initiated a Phase 2 study in Japan and is on track with three pivotal Phase 3 trials for obicetrapib. As of December 31, 2022, the company reported €439 million in cash and €98 million in revenue.
NewAmsterdam Pharma Company, a clinical-stage firm focused on cardiometabolic diseases, announced CEO Michael Davidson’s participation in the Cowen 43rd Annual Health Care Conference on March 7 and 8, 2023. Davidson will discuss cardiovascular therapies and present the company's innovations. NewAmsterdam is developing obicetrapib, an oral CETP inhibitor, aimed at reducing LDL-C levels in high-risk cardiovascular patients. Previous trials, including ROSE and ROSE2, showed significant LDL-C reductions with obicetrapib. The company recently completed a $328 million business combination with Frazier Lifesciences and secured licensing rights for obicetrapib in Europe.
NewAmsterdam Pharma Company announced that Michael Davidson, M.D., CEO, will present at the SVB Securities Global Biopharma Conference on February 16, 2023, at 1:00 p.m. ET. The presentation can be accessed live via the investor relations section of their website with an archived replay available later.
The company focuses on developing oral therapies for cardiometabolic diseases. Its lead candidate, obicetrapib, has shown promising Phase 2b trial results, achieving a median 51% reduction in LDL-C levels in high-risk cardiovascular patients. Recently, NewAmsterdam completed a business combination with Frazier Lifesciences, securing around $328 million in proceeds to further its development efforts.
NewAmsterdam Pharma announced the appointment of John W. Smither as an independent director on its Board of Directors, effective February 6, 2023. He will also serve as chair of the Audit Committee. Smither brings extensive experience in the life sciences sector, having previously held CFO roles at Arcutis Biotherapeutics and Sienna Biopharmaceuticals. His expertise is expected to support the company's ongoing clinical trials for obicetrapib and enhance its strategic leadership post-public listing. The company has a robust capital position, with approximately $328 million from its recent business combination and significant licensing agreements in Europe.
NewAmsterdam Pharma Company announced positive topline results from its Phase 2 clinical trial ROSE2, evaluating the LDL-C lowering effects of obicetrapib in combination with ezetimibe. The trial achieved its primary endpoint with a statistically significant median LDL-C reduction of 59% in the combination group compared to 6% in the placebo group (p < 0.0001). The combination was well-tolerated, and the company plans to advance to bioequivalence and Phase 3 trials. Obicetrapib is a promising CETP inhibitor aimed at improving treatment for patients needing additional LDL-C reduction alongside high-intensity statin therapy.
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