Based on the encouraging results observed, NewAmsterdam is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe, a non-statin oral LDL-lowering therapy, to be tested in a definitive bioequivalence trial and a Phase 3 safety and efficacy trial.
Elevated levels of LDL cholesterol (LDL-C) remain a significant public health burden despite the availability of statins. While a range of adjunctive treatments are available, many patients are not able to benefit because these agents either do not sufficiently lower LDL-C or are too expensive,' said
Topline Data from the ROSE2 Trial
We are excited to announce topline data from ROSE2, which provide support for our belief that obicetrapib and ezetimibe have distinct, complementary mechanisms of action that, when synergized, have the potential to deliver positive outcomes for patients needing further LDL-C reduction,' said
ROSE2 (NCT05266586) was designed as a placebo-controlled, double-blind, randomized Phase 2 study 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. A total of 119 patients were randomized to receive combination therapy, obicetrapib 10 mg or placebo for an 84-day treatment period. The primary efficacy endpoint was the percent change from Day 1 to Day 84 in LDL-C for the combination treatment group compared to the placebo group and was met. Patients treated with the combination of obicetrapib and ezetimibe achieved a median reduction in LDL-C of 59%, as compared to patients treated with placebo, who achieved a median reduction in LDL-C of 6%. Overall, the combination of obicetrapib and ezetimibe was observed to be well-tolerated, with a safety profile observed to be comparable to placebo.
Based on the data from ROSE2, we are now focused on selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe to advance into a definitive bioequivalence study and a Phase 3 trial,' said
NewAmsterdam anticipates sharing full data from this Phase 2 clinical trial in a forthcoming publication or in a presentation at an upcoming medical meeting.
About Obicetrapib
Obicetrapib is a next-generation, oral, low-dose CETP inhibitor that the Company 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 51% lowering of LDL-C from baseline at a 10 mg dose level on top of high-intensity statins. In all three of the Company's Phase 2 trials, TULIP, ROSE and OCEAN, evaluating obicetrapib as a monotherapy or a combination therapy, the Company observed statistically significant LDL-lowering activity combined with generally moderate side effects and no drug-related, treatment-emergent serious adverse events. Obicetrapib has demonstrated strong tolerability in more than 600 patients with low or elevated lipid levels ('dyslipidemia') in NewAmsterdam's clinical trials to date. The Company is conducting two Phase 3 pivotal trials,
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. Based in
Forward-Looking Statements
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