Newamsterdam Pharma Successfully Completes Patient Enrollment for Pivotal Phase 3 BROADWAY Clinical Trial Studying Obicetrapib in Individuals
Wednesday, July 26, 2023
NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) has successfully completed patient enrollment for its pivotal Phase 3 BROADWAY clinical trial. The trial assesses the effectiveness of obicetrapib, an oral, non-statin medicine developed by the company, for patients at high risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) levels. These patients have not achieved adequate control of their LDL-C levels despite being on maximally tolerated lipid-lowering therapy.
The Phase 3 trial exceeded its target enrollment of 2,400 subjects due to strong interest from patients and physicians globally. NewAmsterdam now expects over 2,500 patients to be randomized after completing ongoing patient screenings, and the company plans to report topline data in the second half of 2024.
The Phase 3 BROADWAY trial is a double-blind, placebo-controlled study that includes patients with heterozygous familial hypercholesterolemia (HeFH) and/or established atherosclerotic cardiovascular disease (ASCVD). Patients in the trial have a mean baseline LDL-C level of approximately 100 mg/dL, with over 60% of them reporting high-intensity statin use during screening. The trial enrolled both male and female participants, with females comprising around 30% of the study population. The median age of the participants is approximately 66 years.
During the 52-week trial period, patients were randomly assigned to receive either a placebo or a 10 mg dose of obicetrapib. This treatment was administered once daily orally, with or without food, on top of their maximally tolerated lipid-lowering therapy. The primary objective of the trial is to assess the effect of obicetrapib on LDL-C levels at day 84. Secondary objectives include evaluating its impact on various other lipid and lipoprotein parameters related to cardiovascular disease risk, such as apolipoprotein B, lipoprotein(a), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, and triglycerides at day 84, as well as LDL-C levels at days 180 and 365. The trial also assesses the safety and tolerability of obicetrapib.
Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, expressed satisfaction with the trial's over-enrollment, indicating significant demand for a convenient oral therapy to address unmet needs of patients not achieving their risk-based LDL-C goals despite current treatments. The company's CETP inhibitor, obicetrapib, has shown promising results in reducing LDL-C and impacting other lipid parameters related to cardiovascular disease risk in previous clinical trials.
John Kastelein, M.D., Ph.D., FESC, Chief Scientific Officer of NewAmsterdam, highlighted the importance of addressing HeFH and ASCVD, which can lead to severe cardiovascular events if not adequately managed. Lowering LDL-C levels has been linked to reducing the risk of adverse cardiovascular events, and obicetrapib aims to provide substantially better LDL-C reductions compared to existing non-statin oral therapies in a convenient and well-tolerated form.
Obicetrapib is a novel CETP inhibitor that has demonstrated its potential in earlier trials, showing significant LDL-C lowering when used alone or in combination with other medications. The drug has exhibited strong tolerability in more than 800 patients with dyslipidemia in previous clinical trials.
NewAmsterdam is conducting two Phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate the effectiveness of obicetrapib as a monotherapy or adjunct therapy for high-risk CVD patients who require additional LDL-lowering despite maximally tolerated lipid-lowering therapies. Additionally, the company has started the Phase 3 PREVAIL CVOT trial, designed to assess obicetrapib's potential to reduce major adverse cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and coronary revascularization.
NewAmsterdam remains hopeful that the data from both BROADWAY and BROOKLYN trials will support a potential regulatory filing for obicetrapib's use in managing LDL-C levels for patients at high risk of cardiovascular disease.
