NewAmsterdam Pharma Presents Full Data from Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy at NLA Scientific Sessions 2023
– Met Primary Endpoint with
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– New Data Demonstrate Statistically Significant and Clinically Meaningful Improvements in Additional Lipid and Lipoprotein Parameters Predictive of Cardiovascular Disease Risk, Such as LDL Particles and Lipoprotein(a) –
– Favorable Safety and Tolerability Observed –
– Selected Fixed-Dose Combination Tablet Formula; Phase 3 Trial Expected to Initiate 1Q 2024 –
– Management to Host Conference Call at 8:00 a.m. ET on Monday, June 5, 2023 –
NAARDEN, the Netherlands and MIAMI, June 03, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a clinical-stage biopharmaceutical company developing oral, non-statin medicines for patients at high risk of cardiovascular disease (“CVD”) with residual elevation of low-density lipoprotein cholesterol (“LDL-C” or “LDL”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced the full results of ROSE2, a Phase 2 clinical trial evaluating obicetrapib, the Company’s oral, low-dose and once-daily cholesteryl ester transfer protein (“CETP”) inhibitor, in combination with ezetimibe as an adjunct to high-intensity statin therapy. The data are being presented in an oral late-breaker presentation today at the National Lipid Association (“NLA”) Scientific Sessions 2023 and will be published concurrently in the Journal of Clinical Lipidology.
ROSE2 met its primary and secondary endpoints, with statistically significant and clinically meaningful reductions in LDL-C and apolipoprotein B (“ApoB”) observed. Statistically significant improvements in lipoprotein(a) (“Lp(a)”), non-HDL cholesterol (“non-HDL-C”) and total and small LDL particles were also observed. In addition, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo. With these data in hand, the Company has selected a formulation for a fixed-dose combination tablet and intends to advance the compound into a Phase 3 trial in the first quarter of 2024.
“The 2022 ACC Expert Consensus Decision Pathway has recommended that very high risk patients with LDL-C above 55mg/dl need additional therapy to maximize proven risk reduction. With these new recommendations, many more patients will fail to achieve guideline-mandated LDL-C goals, demonstrating the limitations of existing therapeutics and the critical need for new options,” said Christie M. Ballantyne, M.D., Chief of Cardiovascular Research and Professor at Baylor College of Medicine and principal investigator on the clinical trial. “The data presented today are highly encouraging, showing that the combination of obicetrapib and ezetimibe delivers robust impacts on multiple atherogenic lipid parameters. I believe the observed reductions in LDL-C, ApoB, Lp(a) and total and small LDL particles are potentially predictive of profound reductions in the risk of cardiovascular events and look forward to further characterizing the combination obicetrapib and ezetimibe regimen in a Phase 3 trial.”
“The ROSE2 data build on our prior clinical experience, supporting the potential for obicetrapib to become a new standard-of-care combined safely with existing options to deliver improved outcomes to the millions of very high-risk patients in need. We are particularly encouraged by the new goal attainment data announced today, through which we observed that 87 percent of patients treated with the combination regimen of obicetrapib and ezetimibe met the most aggressive guideline-mandated LDL-C target of <55 mg/dL,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, “We have selected a fixed-dose combination tablet formula and look forward to advancing it into a Phase 3 trial, targeted to commence in the first quarter of 2024. In addition, we continue to progress our ongoing BROADWAY, BROOKLYN and PREVAIL trials according to plan. We believe that clinicians and patients are seeking oral options in addition to maximally tolerated statin therapy to reduce the risk of cardiovascular disease. Obicetrapib 10mg as monotherapy and in a fixed dose combination with ezetimibe, if successful in our Phase 3 trials, could well be the therapeutic solution that is so sorely needed.”
Full Data from the Phase 2 ROSE2 Clinical Trial of Obicetrapib and Ezetimibe
ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase 2 clinical trial to evaluate the efficacy, safety and tolerability of obicetrapib 10 mg in combination with ezetimibe 10 mg as an adjunct to high-intensity statin therapy. Patients were randomized to receive combination therapy, obicetrapib 10 mg or placebo for a 12 week treatment period. A total of 119 patients enrolled in ROSE2, of which 97 were included in the on-treatment analysis. Patients presented at baseline with a fasting LDL-C greater than 70 mg/dL and triglycerides (“TG”) less than 400 mg/dL and all were receiving a stable dose of high-intensity statin therapy.
The primary endpoint was the percent change from baseline to week 12 in Friedewald-calculated LDL-C for the obicetrapib plus ezetimibe combination treatment group compared with placebo. Secondary efficacy endpoints included the percent changes from baseline to week 12 in LDL-C for obicetrapib monotherapy compared with placebo and in ApoB for the obicetrapib plus ezetimibe combination compared with placebo and the obicetrapib monotherapy compared with placebo. Exploratory endpoints included the percent changes from baseline to week 12 in Lp(a), non-HDL-C, HDL-C, total and small LDL particles assessed by NMR, and the proportion of patients at the end of treatment who achieved LDL-C levels below 100 mg/dL, 70 mg/dL and 55 mg/dL for the obicetrapib plus ezetimibe combination and obicetrapib monotherapy groups compared with placebo.
The p-value for the LS mean for each endpoint compared to placebo was <0.0001. The table below shows the median percent change from baseline in patients receiving the combination of obicetrapib and ezetimibe, obicetrapib monotherapy and placebo.
| Median percent change from baseline | Placebo (n=40) | Obicetrapib 10mg (n=26) | Obicetrapib 10 mg + Ezetimibe 10 mg (n=31) |
| Friedewald-calculated LDL-C | -6.4 | -43.5 | -63.4 |
| ApoB | -2.1 | -24.2 | -34.4 |
| Non-HDL-C | -5.6 | -37.5 | -55.6 |
| Total LDL particles | -5.7 | -54.8 | -72.1 |
| Small LDL particles | -8.3 | -92.7 | -95.4 |
| LDL particle size | -0.5 | 1.5 | 1.8 |
The combination of obicetrapib plus ezetimibe resulted in significantly more patients achieving LDL-C levels of less than 100, less than 70 and less than 55 mg/dL than the placebo group (
Treatment with the combination of obicetrapib and ezetimibe was observed to be generally well-tolerated, with a safety profile comparable to placebo. Adverse events were generally mild to moderate, with the most prevalent adverse events being nausea, urinary tract infection and headache, and no drug-related, treatment-emergent serious adverse events were observed.
“We are particularly encouraged by the new lipid particle analysis, in which we observed reductions in Lp(a) and both total and small LDL particles in patients who received the combination of obicetrapib and ezetimibe,” said John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam. “An observed reduction of almost
Under the terms of NewAmsterdam’s licensing agreement with the Menarini Group, data from the ROSE2 trial triggered a clinical success milestone payment to NewAmsterdam, which was received in April 2023.
Conference Call Information
NewAmsterdam will host a live conference call on Monday, June 5, 2023 beginning at 8:00 a.m. ET to review the full data from the Phase 2 ROSE2 clinical trial. Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.
A live webcast of the call will also be available under “Events & Presentations” in the Investors & News section of the Company’s website at https://ir.newamsterdampharma.com.
About Obicetrapib
Obicetrapib is a next-generation, oral, low-dose CETP inhibitor that NewAmsterdam is developing to potentially overcome the limitations of current LDL-lowering treatments. The Company believes that obicetrapib has the potential to be a once-daily oral CETP inhibitor for lowering LDL-C, if approved. In the Company’s Phase 2b ROSE trial, obicetrapib demonstrated a
About NewAmsterdam
NewAmsterdam (Nasdaq: NAMS) is a clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated. NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk cardiovascular disease (“CVD”) patients. Results from NewAmsterdam’s ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) included observations that patients receiving obicetrapib 10 mg experienced a median reduction in LDL-C of
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Company Contact
Matthew Philippe
P: 1 917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Jenn Gordon
P: 1 202-957-7795
jgordon@spectrumscience.com
Investor Contact
Stern Investor Relations on behalf of NewAmsterdam
Hannah Deresiewicz
P: 1 212-362-1200
hannah.deresiewicz@sternir.com
