Menarini Group Reports Positive Phase 3 Trial Results for Obicetrapib and Obicetrapib-Ezetimibe Combination

In a recent announcement from Florence, Italy, the Menarini Group reported promising results from two major Phase 3 clinical trials, BROADWAY and TANDEM. Both studies were conducted under the sponsorship of NewAmsterdam Pharma Company N.V., focusing on the efficacy and safety of Obicetrapib, an oral, non-statin medication designed for patients at risk of cardiovascular disease who struggle with high levels of low-density lipoprotein cholesterol (LDL-C) despite the use of existing therapies.

The BROADWAY trial aimed to assess the impact of a 10 mg dose of Obicetrapib on adults with either heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD). These patients had not achieved sufficient control over their LDL-C levels, even with maximally tolerated lipid-lowering therapies. The study successfully reached its primary endpoint, demonstrating a significant 33% reduction in LDL-C levels compared to placebo, with statistical significance marked at p<0.0001. Furthermore, there was a noted 21% decrease in major adverse cardiovascular events among participants receiving Obicetrapib after one year.

Safety profiles in the BROADWAY trial revealed that Obicetrapib was well tolerated, showing favorable results in terms of glycemic control and renal function. Adverse events such as treatment discontinuations and other side effects were closely monitored, and overall, the treatment was comparable to placebo.

Similarly, the TANDEM trial evaluated the combination of 10 mg Obicetrapib and 10 mg Ezetimibe in patients with HeFH, ASCVD, or multiple ASCVD risk factors. Like BROADWAY, these participants had not adequately controlled their LDL-C levels despite current therapies. The trial's primary endpoints were also achieved, with the fixed-dose combination therapy resulting in a substantial 48.6% reduction in LDL-C compared to placebo, again with significant statistical backing at p<0.0001.

The TANDEM trial further affirmed the tolerability of the Obicetrapib and Ezetimibe combination, with safety data aligning closely with that of the placebo group. The study focused not only on LDL-C reduction but also evaluated changes in other biomarkers, such as lipoprotein(a), non-HDL cholesterol, and apolipoprotein B.

These trials are part of a larger global phase 3 program for Obicetrapib, incorporating a series of studies that involve over 12,250 patients. The comprehensive program includes both monotherapy trials and fixed-dose combination approaches to thoroughly assess the efficacy and safety of Obicetrapib in diverse patient populations with cardiovascular risks.

Elcin Barker Ergun, CEO of the Menarini Group, expressed satisfaction with the results, highlighting the trials’ success in achieving significant LDL-C reductions. This marks a crucial step toward introducing a potentially groundbreaking, low-dose, once-daily oral treatment for cardiovascular diseases in Europe, reinforcing Menarini's longstanding commitment to addressing unmet medical needs in this area.

The outcomes from BROADWAY and TANDEM provide encouraging evidence for Obicetrapib's role as a promising treatment option, offering new hope for patients whose cardiovascular conditions are not adequately managed with existing lipid-lowering therapies. These findings also contribute to the ongoing development of Obicetrapib as part of an innovative therapeutic strategy aimed at reducing cardiovascular risks and enhancing patient care.