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3月前
BAMS NAMS $27+ 56% 40m float
NAARDEN, The Netherlands and MIAMI, Dec. 10, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced positive topline data from the Company’s Phase 3 BROADWAY clinical trial (NCT05142722) evaluating obicetrapib in adult patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.“We initiated four Phase 3 trials with obicetrapib in December 2021, with the hope that obicetrapib would become the therapeutic option of choice to add to statin therapy to further reduce cardiovascular (“CV”) risk,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Our aspiration was that our Phase 3 trials would not only confirm the efficacy and tolerability observed in Phase 2 but also clearly demonstrate a safety and clinical profile that would differentiate obicetrapib from other LDL-C lowering therapies. We are proud to have observed in our Phase 3 trials to date not only durable LDL-C reduction in both the monotherapy obicetrapib group and the obicetrapib combination with ezetimibe group, but also a safety and tolerability profile that exceeded our expectations. We have observed obicetrapib, an oral, once-a-day, low-dose tablet, to be clinically differentiated from other lipid lowering therapies by lowering Lp(a) and small LDL-particles as well as potentially improving glycemic measures that are linked to high CV risk. Although exploratory at this point, the difference in major adverse cardiovascular events (“MACE”) at one year in BROADWAY supports our belief that obicetrapib could provide greater than expected CV risk reductions through mechanisms beyond LDL-C lowering. In 2025, we look forward to presenting additional BROADWAY and TANDEM data at upcoming scientific sessions and meeting with regulatory authorities to discuss filings for this important therapy to address the global unmet need for effective LDL-C lowering therapies.”The primary endpoint was the least-squares mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo, using imputation for missing data. The primary endpoint was achieved with statistical significance with an LDL-C reduction of 33% (p<0.0001).LDL-C percentage change at day 84: Placebo
(n = 844)Obicetrapib 10 mg
(n = 1686)DifferenceMean-2%-35%-33%Median-4%-40%-36%LS mean (with imputation)+3%-30%-33%As part of the safety analysis, the trial adjudicated MACE, including death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization. In addition, a 21% reduction in MACE favoring obicetrapib was observed.Major adverse cardiovascular events table: Placebo
(n = 844)Obicetrapib 10 mg
(n= 1686)Hazard Ratio95% CIAll-cause mortality – no. (%)12 (1.4)19 (1.1)0.83(0.40-1.71)Coronary heart death – no. (%)5 (0.6)8 (0.5)0.80(0.26-2.44)First 4-point MACE – no. (%)44 (5.2)70 (4.2)0.79(0.54-1.15)4-point MACE: CHD death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization. MACE was not a primary or secondary endpoint of the BROADWAY trial.“I have provided leadership to cardiovascular drug development since the early statin days and was thrilled to see a safety profile as clean as obicetrapib, which has been comparable to placebo. Having lived and witnessed the accumulation of efficacy and safety data for obicetrapib from early Phase 1 through Phase 3, this moment is an exciting milestone,” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “The unexpected magnitude of difference in MACE and early separation in the Kaplan-Meier curves that we observed may indicate obicetrapib’s potential benefit above LDL-C lowering alone. MACE risk is multifaceted and obicetrapib has shown consistent benefit in our clinical trials across a variety of drivers but ultimately, getting patients’ LDL-C to target is what I care about. I am optimistic that obicetrapib monotherapy and in combination with ezetimibe each could help most patients reach these goals, if approved.”The observed changes in other biomarkers, including high-density lipoprotein cholesterol (“HDL-C”), non-HDL-C, lipoprotein(a) (“Lp(a)”), apolipoprotein B (“ApoB”), and Apolipoprotein A1 (ApoA1) were consistent with data reported in the Company’s prior clinical trials.As part of the safety analysis, key adverse events (“AE”) of special interests were monitored. Among these AEs, glycemic control and renal function were monitored and each of the events favored obicetrapib. Overall, obicetrapib was also observed to be well-tolerated, with safety results, including blood pressure, comparable to placebo. The treatment discontinuation rate for the obicetrapib arm was 11.1% versus 12.4% for placebo. The incidence of treatment-emergent adverse events (“TEAEs”), trial-drug related TEAEs, and treatment-emergent serious adverse events (“TESAEs”) are summarized in the table below.?Placebo
N=843
n (%)Obicetrapib 10 mg
N=1,685
n (%)?Any TEAEs513 (60.9)1007 (59.8)Any trial drug related TEAEs?39 (4.6)76 (4.5)Any TEAEs leading to discontinuation of trial drug?43 (5.1)68 (4.0)Any TESAEs117 (13.9)211 (12.5)“Despite the widespread availability of lipid-lowering therapies, patients are still struggling to achieve target LDL-C levels and CVD-related death rates continue to rise,” said Stephen Nicholls, M.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University. “The BROADWAY clinical trial highlights the transformative potential of obicetrapib — a powerful, well-tolerated, and convenient treatment option for millions with dyslipidemia, if approved, could help them reach their LDL-C goals and significantly reduce the risk of life-threatening cardiovascular events.”NewAmsterdam plans to present additional results from BROADWAY at an upcoming medical conference and to publish the data in a major medical journal.Design of the Pivotal Phase 3 BROADWAY Clinical TrialThe 52-week, global, pivotal, Phase 3, randomized, double-blind, placebo-controlled multicenter trial evaluated the efficacy and safety of 10 mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled. The trial was conducted at sites in North America, Europe, Asia and Australia. A total of 2,530 patients were randomized 2:1 to receive 10 mg obicetrapib or placebo dosed as a once-daily oral treatment, with or without food for 52 weeks. The mean baseline LDL-C for enrolled patients in the obicetrapib arm was approximately 100 mg/dL despite high intensity statin use reported by nearly 70% of patients during screening. Females comprised approximately 34% of the trial population and the median age of participants at baseline was 65 years.The primary endpoint was LS mean percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days which showed a reduction of 33% with imputation. Secondary endpoints also included percent changes from baseline of obicetrapib 10 mg compared to placebo in ApoB, Lp(a), ApoA1, HDL-C, non-HDL-C, total cholesterol, and triglycerides at day 84, and on LDL-C levels at days 180 and 365 (mean -34% and imputed LS mean of -24%, respectively with p<0.0001). Other exploratory outcome measures included time from randomization until the first confirmed occurrence of MACE in the obicetrapib arm compared to placebo. The trial also evaluated the safety and tolerability profile of obicetrapib.Conference Call and Webcast InformationNewAmsterdam will host a live webcast and conference call to review the topline results from BROADWAY at 8:00 a.m. ET today. To access the live webcast, participants may register here. The live webcast will be available under the "Events” section of the Investor Relations page of the NewAmsterdam website at ir.newamsterdampharma.com.
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