Therapy Areas: Cardiovascular
NewAmsterdam Pharma Doses First Patient in Phase 2 Trial of Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy
6 April 2022 - - Netherlands-based clinical-stage company NewAmsterdam Pharma has dosed the first patient in ROSE2, the company's Phase 2 trial of obicetrapib, a novel cholesteryl ester transfer protein inhibitor, the company said.

ROSE2 is 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 and as monotherapy, in each case as an adjunct to high-intensity statin therapy.

Ezetimibe is a cholesterol absorption inhibitor that works by partially blocking the absorption of cholesterol in the small intestine, causing the upregulation of low-density lipoprotein receptors - a mechanism of action that NewAmsterdam believes could be additive and potentially synergistic with CETP inhibition for reducing levels of low-density lipoprotein cholesterol (LDL-c).

Participants will be randomized to receive combination therapy (i.e., obicetrapib 10 mg + ezetimibe 10 mg), obicetrapib monotherapy (obicetrapib 10 mg), or placebo.

The primary objective of the ROSE2 trial is to evaluate the efficacy endpoint, which is the percent change from Day 1 to Day 84 in LDL-c for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group.

A total of 108 patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10mg obicetrapib + 10mg ezetimibe combination therapy, dosed as a once-daily oral treatment for an 84-day treatment period.

Obicetrapib is a selective cholesteryl ester transfer protein inhibitor in development for lowering low-density lipoprotein cholesterol (LDL-c) and preventing major adverse cardiovascular events.

More than 100m people globally are not achieving LDL-c goals despite the current available standard of care.

Obicetrapib was previously tested in ROSE and TULIP1 randomized double-blind, placebo-controlled Phase 2 trials.

Results from the ROSE trial, presented in November 2021 at the AHA Scientific Sessions, demonstrated that patients on statin therapy who received 5 mg of obicetrapib saw an LDL-c reduction of 42%.

Patients who were part of the 10 mg cohort experienced a 51% reduction versus baseline, while the placebo cohort experienced a 7% reduction versus baseline.

Both doses were well tolerated, with no serious adverse effects in the two cohorts and two serious AEs in the placebo arm.

NewAmsterdam Pharma is a private clinical-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where traditional therapies have been unsuccessful or are not tolerated.

NewAmsterdam is investigating obicetrapib, a next-generation cholesteryl ester transfer protein inhibitor, as the preferred LDL-c-lowering therapy for high-risk cardiovascular disease patients.

The company's ROSE Phase 2b trial (presented at AHA Scientific Sessions in 2021) showed that obicetrapib 10mg reduced LDL-c by 51% versus baseline in patients on statin therapy (vs. a 7% reduction in the placebo arm).

Based in the Netherlands, NewAmsterdam was founded in 2019 by the venture capital firm Forbion and John Kastelein, and closed a USD 196m (EUR 161m) series A financing in January 2021 led by Forbion, Morningside Ventures and Ascendant BioCapital.
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