Phase III BROOKLYN Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia Meets Primary Endpoint
The CETP inhibitor lowered low-density lipoprotein cholesterol by 36.3% at day 84 and 41.5% at day 365 compared to placebo.
NewAmsterdam Pharma has shared positive results from its pivotal Phase III BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia (HeFH). The trial met its primary endpoint, achieving an LS mean reduction of 36.3% compared to placebo at day 84, which was sustained at day 365 with an LS mean low-density lipoprotein cholesterol (LDL-C) reduction of 41.5%.1
Additionally, obicetrapib showed reductions in other key biomarkers including high-density lipoprotein cholesterol (HDL-C), non-HDL-C, lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB). These reductions are consistent with data from NewAmsterdam’s other clinical studies.
“Today’s announcement marks an important milestone for NewAmsterdam, the HeFH community, and CVD more broadly,” Michael Davidson, MD, chief executive officer of NewAmsterdam said in a press release. “Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets. Patients and their doctors need additional options. We are very excited about the results from our BROOKLYN trial and believe they support obicetrapib’s potential to significantly reduce LDL-C in a challenging patient population, over a duration of one year. Adverse events and discontinuations due to side effects were similar to placebo, consistent with what was observed in Phase II studies. In the safety population, there was also no increase in blood pressure, nor any difference from placebo in liver enzymes, hs-CRP, or renal function. We look forward to building on these results with topline data from BROADWAY expected in the fourth quarter of 2024, and topline data from TANDEM expected in the first quarter of 2025.”
The pivotal Phase III BROOKLYN trial was a randomized, double-blind, placebo-controlled multicenter study. Over the course of 52 weeks, it evaluated the efficacy and safety of 10mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with HeFH whose LDL-C is not adequately controlled. A total of 354 patients were randomized across sites in North America, Europe, and Africa.
Earlier in July, NewAmsterdam announced it had completed enrollment for its Phase III TANDEM trial (NCT06005597) which is evaluating the fixed-dose combination (FDC) of obicetrapib plus ezetimibe in adult patients with HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) or multiple risk factors for ASCVD, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies.2
This trial is a double-blind, placebo-controlled study which enrolled 407 patients.
“Completing enrollment of the pivotal Phase III TANDEM trial marks an important step in our mission of advancing obicetrapib through late-stage clinical development and brings us closer to delivering a simple and convenient once-daily tablet to the millions of people suffering from dyslipidemia,” Davidson said in an earlier press release. “With positive enrollment trends observed in four ongoing contemporaneous pivotal Phase III studies— BROOKLYN, BROADWAY, PREVAIL and TANDEM—we continue to be encouraged by physician and patient interest in our clinical trials, which we believe reflects growing awareness of our CETP inhibitor and its potential ability to address elevated LDL-C and improve health outcomes for millions of patients globally, if approved. We look forward to sharing topline data from the TANDEM study in the first quarter of 2025.”
References
1. NewAmsterdam Pharma Announces Positive Topline Data from Pivotal Phase 3 BROOKLYN Clinical Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia. News release. NewAmsterdam. July 29, 2024. Accessed July 29, 2024. https://ir.newamsterdampharma.com/news-releases/news-release-details/newamsterdam-pharma-announces-positive-topline-data-pivotal
2. NewAmsterdam Pharma Completes Enrollment in Pivotal Phase 3 TANDEM Clinical Trial Evaluating Fixed-Dose Combination of Obicetrapib plus Ezetimibe in Patients with HeFH and/or ASCVD or ASCVD Risk Factors. News release. NewAmsterdam. July 8, 2024. Accessed July 29, 2024. https://ir.newamsterdampharma.com/news-releases/news-release-details/newamsterdam-pharma-completes-enrollment-pivotal-phase-3-tandem
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
