NAARDEN, The Netherlands and MIAMI – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS), a clinical-stage biopharmaceutical company, announced positive results from its Phase 3 TANDEM clinical trial for a fixed-dose combination of obicetrapib and ezetimibe, intended to treat patients with cardiovascular disease (CVD) and elevated low-density lipoprotein cholesterol (LDL-C). The trial met its co-primary endpoints, demonstrating a significant reduction in LDL-C levels when compared to placebo and each monotherapy.
The study, which spanned across the United States, involved 407 patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), or multiple ASCVD risk factors. These patients had not achieved LDL-C control despite maximally tolerated lipid-lowering therapy. After 84 days of treatment, the combination therapy showed an LS mean reduction in LDL-C of 48.6% compared to placebo, with over 70% of patients achieving LDL-C levels below 55 mg/dL. These results were statistically significant with a p-value of less than 0.001.
The safety profile of the combination therapy was comparable to that of placebo, with the incidence of treatment-emergent adverse events and serious adverse events being similar across all study groups. This data is expected to support global regulatory filings for the combination therapy.
Dr. John Kastelein, Chief Scientific Officer of NewAmsterdam, stated that the trial's outcomes could provide a new treatment option that may improve patient care for those affected by CVD. Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, expressed confidence that the results would aid their regulatory submissions and potentially offer a once-daily treatment capable of significantly reducing LDL-C.
Dr. Ashish Sarraju from the Cleveland Clinic acknowledged the importance of these findings for patients at high risk of cardiovascular disease who are not meeting LDL-C targets with existing therapies.
NewAmsterdam plans to present further data from the TANDEM trial at an upcoming medical conference and publish the findings in a major medical journal. The company is also conducting additional Phase 3 trials, including BROADWAY and PREVAIL, to further evaluate obicetrapib as monotherapy and its potential to reduce major adverse cardiovascular events.
The company's global Phase 3 program, which includes over 12,250 patients, is part of its mission to develop oral, non-statin medicines for patients with metabolic diseases and inadequate or intolerable current therapies. This press release statement serves as the basis for the reported information.
In other recent news, NewAmsterdam Pharma Co NV has received continued support from Piper Sandler and TD Cowen, both maintaining positive ratings based on the company's promising clinical trial results. NewAmsterdam's drug candidate, obicetrapib, is showing significant potential in reducing low-density lipoprotein cholesterol levels. This was evidenced by the successful outcomes of the Phase 3 BROOKLYN clinical trial involving patients with heterozygous familial hypercholesterolemia.
Anticipation is building for the upcoming Phase 3 BROADWAY and TANDEM FDC (NS:FDC) study readouts, expected in the fourth quarter of 2024, which Piper Sandler predicts could significantly impact the company's trajectory. Moreover, the company is preparing for the Phase 3 HORIZON trial of pelacarsen in 2025, which is expected to further support obicetrapib by establishing the relationship between Lp(a) levels and major adverse cardiac events outcomes.
In other developments, NewAmsterdam Pharma has announced a restatement of its financial statements for the years ending 2022 and 2021 due to identified errors in the calculation of net loss per ordinary share. The company has also welcomed new members, Mark C. McKenna and Wouter Joustra, to its Board of Directors. These are the recent developments for NewAmsterdam.
InvestingPro Insights
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) has shown promising results in its Phase 3 TANDEM clinical trial, which could potentially lead to a significant advancement in cardiovascular disease treatment. This positive development aligns with some key financial metrics and insights from InvestingPro.
According to InvestingPro data, NAMS has experienced substantial growth, with a remarkable revenue growth of 78.77% over the last twelve months as of Q3 2024. This growth trajectory is further emphasized by an impressive quarterly revenue growth of 889.83% in Q3 2024. These figures suggest that the company's innovative approach to cardiovascular disease treatment is translating into financial success.
InvestingPro Tips highlight that NAMS holds more cash than debt on its balance sheet, indicating a strong financial position to support its ongoing clinical trials and potential commercialization efforts. Additionally, the company's liquid assets exceed short-term obligations, providing financial flexibility as it progresses through its development pipeline.
Despite these positive indicators, it's worth noting that analysts do not anticipate the company to be profitable this year, which is not uncommon for clinical-stage biopharmaceutical companies investing heavily in research and development. This is reflected in the company's operating income margin of -548.12% over the last twelve months.
Investors seem optimistic about NAMS's potential, as evidenced by the stock's strong performance. InvestingPro data shows a 149.26% price total return over the past year, with a 22.95% return in the last month alone. This performance suggests that the market is responding positively to the company's clinical progress and potential market opportunity.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for NAMS, providing a more comprehensive view of the company's financial health and market position.
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