Obicetrapib

NewAmsterdam REMBRANDT clinical trial to leverage Caristo CaRi-Heart® and CaRi-PlaqueTM technologies for coronary inflammation and plaque measurements and monitoring STAMFORD, Conn. and OXFORD, England, Oct. 14, 2025 /PRNewswire/ -- Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, announced its role as the worldwide imaging core lab for NewAmsterdam Pharma's REMBRANDT Cardiovascular Imaging Trial – overseeing all coronary plaque and inflammation measurements and monitoring. The REMBRANDT trial, sponsored by NewAmsterdam Pharma (Nasdaq: NAMS), is a placebo-controlled, double-blind, randomized trial designed to assess the efficacy of obicetrapib and ezetimibe fixed dose combination (FDC) on coronary plaque burden. Obicetrapib is an investigational cholesteryl ester transfer protein (CETP) inhibitor that has shown to lower low-density lipoprotein cholesterol (LDL-C) in three Phase 3 clinical trials. Favorable changes in noncalcified coronary atherosclerotic plaque volume (NCPV) may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events1. Recently detailed in the American Heart Journal, REMBRANDT is recruiting patients from 50 sites in 7 countries (United States, Poland, United Kingdom, Czech Republic, Hungary, Italy and Spain). The trial's primary efficacy outcome is percent change in total NCPV from baseline to 18 months as assessed by coronary computed tomographic angiography (CCTA). Secondary endpoints include absolute change in total NCPV, percent and absolute change in NCPV, percent change in LDL-C, and change in perivascular fat attenuation index (FAI-ScoreTM) which is Caristo's proprietary biomarker for coronary inflammation and an independent predictor of ASCVD events beyond plaque burden1. Caristo's core laboratory responsibilities for the REMBRANDT trial, include: Certifying and training each clinical site to ensure high-quality CCTA images Conducting baseline and follow-up analyses for all randomized patients at 6 and 18 months Measuring plaque burden, quantifying coronary inflammation using FAI-Score, and providing comprehensive cardiovascular risk calculations Ensuring rigorous image quality control, data anonymization, and radiation dose optimization "We are proud to confirm Caristo's worldwide role in the REMBRANDT clinical trial," said Frank Cheng, CEO, Caristo Diagnostics. "Pharmaceutical and biotech sponsors are increasingly choosing Caristo to evaluate the effect of new drugs on both coronary plaque and inflammation. This growing confidence reflects our proven research capabilities and our technologies' ability to accurately detect coronary inflammation and plaque in support of the drug development process." "Advances in CCTA imaging over the last few years are allowing us to perform high quality mechanistic studies that shed important light on a drug's mode of action," said Dr Cheerag Shirodaria, Honorary Consultant Cardiologist at Oxford University Hospitals NHS Foundation Trust. "The information provided by the REMBRANDT trial will provide clinicians with valuable information on the direct effects of obicetrapib on coronary plaque morphology." "The REMRANDT trial and evaluation of the effects of obicetrapib on coronary plaque and inflammation metrics is an important part of New Amsterdam's clinical development program," said Professor John Kastelein, Co-Founder and Chief Scientific Officer at New Amsterdam Pharma. "We are delighted to have Caristo as a partner on our journey." About Caristo Diagnostics Caristo Diagnostics is a global leader in cardiovascular disease diagnostics and risk prediction, founded as a spin-out company from the University of Oxford. Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. In collaboration with leading hospitals, pharmaceutical companies and world's renowned scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com. Find Caristo online on LinkedIn, YouTube, Instagram, and X. 1 "Rationale and design of the REMBRANDT trial: A phase 3 study to evaluate the effect of obicetrapib/ezetimibe on coronary plaque characteristics". Am Heart J. 2025 Jul 17:290:325-338. doi: 10.1016/j.ahj.2025.07.012. Online ahead of print Logo - SOURCE Caristo Diagnostics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Takeda’s (Japan) Zejula (niraparib) was one of among six innovative anti-cancer medicines across 20 indications that were considered in this study. Credit: Melnikov Dmitriy / Shutterstock. Amgen is hopeful that Phase III data will cement the validity of its recently approved widened label for cholesterol-lowering drug Repatha (evolocumab). In August 2025, the US Food and Drug Administration (FDA) approved the use of Repatha in adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C). Now, the VESALIUS-CV trial (NCT03872401) has proved its long-term efficacy in these patients after meeting both its primary endpoints, proving that Repatha can significantly reduce the risk of MACE in patients without a prior history of heart attack or stroke. The primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke, and time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularisation. The trial enrolled more than 12,000 high-risk patients who were followed for 4.5 years. Of those enrolled, approximately 85% were maintained on a high-intensity or moderate LDL-C reducing therapy. Amgen R&D executive vice-president Dr Jay Bradner said: “The benefit across endpoints and established safety profile underscore Repatha’s role as a cornerstone therapy in comprehensive lipid management. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Repatha is known as a highly effective LDL-C-lowering treatment and is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke. These additional data demonstrate that Repatha has the potential to reach tens of millions more patients earlier in their journey, before a life-altering event occurs.” Amgen has not yet released data from the trial; however, this is set to be presented at the American Heart Association Scientific Sessions on 8 November. Repatha was first approved in the US for adults with high cholesterol who require further LDL-C reduction on 27 August 2015. This came after European approval, making it the first PCSK9 inhibitor to receive regulatory clearance worldwide. Its long market presence means it is coming close to the end of its patent-protected period, due to end in 2030, opening up an opportunity for biosimilars. GlobalData predicts this will dent Amgen’s market dominance, with peak sales for the drug reaching $3.87bn in 2029 before slowly dropping, with a 2031 sales forecast of $3.32bn. GlobalData is the parent company of Clinical Trials Arena . Repatha’s main market competition comes from Praluent (alirocumab), a PCSK9 inhibitor developed by Regeneron and Sanofi, which gained US approval before Repatha, but EU approval came later. Praluent sales are set to reach $880m in 2031, according to GlobalData. After Praulent’s approval, Regeneron and Sanofi, and Amgen were embroiled in a patent dispute over the two therapies, with Amgen emerging victorious . Amgen also faces competition from Novartis’ Leqvio (inclisiran), a long-acting small-interfering RNA (siRNA) that degrades PCSK9. GlobalData predicts sales will rise sharply, from $754m in 2024 to $3.98bn in 2031. A number of LDL-C-lowering drugs have also recently shown promise, including LIB Therapeutics’ lerodalcibep, AstraZeneca’s AZD0780 and NewAmsterdam Pharma’s obicetrapib. GlobalData predicts the total dyslipidemia (high cholesterol) market will reach $15.53bn across seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by 2032. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now