1 August 2022 - - Netherlands-based clinical-stage company NewAmsterdam Pharma, focused on the research and development of transformative oral therapies for metabolic diseases, has initiated BROOKLYN, a pivotal Phase 3 clinical trial of obicetrapib in adult patients with a history of heterozygous familial hypercholesterolemia, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies, the company said.

Obicetrapib is NewAmsterdam's next-generation oral, low-dose and once-daily cholesteryl ester transfer protein inhibitor, initially in development for patients at high risk for cardiovascular disease as an adjunct to maximally tolerated statin therapy, both as a monotherapy and in a fixed-dose combination with ezetimibe.

The primary objective of the placebo-controlled, double-blind, randomized BROOKLYN trial is to evaluate the effect of obicetrapib on LDL-C levels.

Secondary objectives include evaluating the effect of obicetrapib on fasting lipoprotein (a), apolipoprotein B, and non-high-density lipoprotein cholesterol (non-HDL-C). The trial will also evaluate the safety and tolerability profile of obicetrapib.

Approximately 300 patients on maximally tolerated lipid-modifying therapies with a history of HeFH, an inherited genetic disorder that causes dangerously high cholesterol levels, and who have a baseline LDL-C of at least 70 mg/dL will be randomized to placebo or 10 mg obicetrapib dosed as a once daily oral treatment for a 52-week treatment period.

In addition to the BROOKLYN trial, NewAmsterdam Pharma is currently evaluating obicetrapib in two Phase 3 trials, BROADWAY (LDL-lowering capability in patients with established atherosclerotic cardiovascular disease or HeFH with LDL-C ≥ 70 mg/dL) and PREVAIL (CVOT in patients on maximum tolerated lipid-modifying with atherosclerotic cardiovascular disease with LDL-C ≥ 70 mg/dL), and a Phase 2b trial, ROSE2, which is examining obicetrapib as a fixed-dose combination therapy with obicetrapib 10 mg and ezetimibe 10 mg in patients on high-intensity statin therapy with LDL-C ≥ 70 mg/dL.

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 not been sufficiently successful or well-tolerated.

NewAmsterdam Pharma is investigating obicetrapib, a next-generation oral, low-dose and once-daily CETP inhibitor, as the preferred LDL-C-lowering therapy for high-risk cardiovascular disease patients.

Results from NewAmsterdam Pharma'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 by 51% versus baseline in patients on statin therapy (vs. a 7% reduction in the placebo arm).

Based in the Netherlands, NewAmsterdam Pharma was founded in 2019 by the venture capital firm Forbion and John Kastelein, chief scientific officer of the NewAmsterdam Pharma, and closed a USD 196m (EUR 160m) series A financing in January 2021 led by Forbion, Morningside Ventures and Ascendant BioCapital.

In June 2022, NewAmsterdam Pharma entered into an exclusive licensing agreement with the Menarini Group for the commercialization of obicetrapib in Europe, while retaining all rights to commercialize obicetrapib, if approved, in the rest of the world, as well as rights to develop certain forms of obicetrapib for other diseases such as Alzheimer's disease.

Frazier Lifesciences Acquisition Corp. is blank check company incorporated as a Cayman Islands exempted company in October 2020 for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities.

FLAC was formed to leverage the extensive experience and track record of its management team with the goal of financing a company that can both develop transformative therapies for patients in need and deliver significant returns to its investors.

Founded in 1991, Frazier Healthcare Partners is a provider of private equity capital to healthcare companies.