Menarini Group Reports Positive Phase-3 Results for Obicetrapib and Ezetimibe Combination Therapy
On December 17, 2024, Menarini Group released compelling topline data from its pivotal Phase-3 clinical studies, BROADWAY (NCT05142722) and TANDEM (NCT06005597). These studies evaluated the efficacy of Obicetrapib, both as a monotherapy and in a fixed-dose combination with Ezetimibe at 10 mg, aimed at treating patients who struggle with high levels of low-density lipoprotein cholesterol (LDL-C). Notably, both studies successfully met their primary endpoints, demonstrating significant reductions in LDL-C levels alongside maximum tolerated lipid-lowering therapies with high statistical significance (p < 0.0001).
In the BROADWAY trial, involving adult patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherothrombotic cardiovascular disease (ASCVD), the results showed that approximately 50% of patients on Obicetrapib monotherapy achieved LDL-C targets below 55 mg/dL. Furthermore, this study indicated a noteworthy 21% reduction in major adverse cardiovascular events (MACE) over a one-year period for participants receiving Obicetrapib.
In the TANDEM study, which focused on the combination of Obicetrapib and Ezetimibe, over 70% of the patients reached the same LDL-C target. Participants displayed average LDL-C reductions of 48.6% from baseline, reinforcing the combination therapy's effectiveness as a daily, non-statin lipid-lowering option.
Both trials reported that Obicetrapib, whether administered alone or in combination with Ezetimibe, was well tolerated. Adverse event rates were comparable to those of placebo, indicating no significant safety concerns. The dropout rates due to adverse effects remained low, with only 11.1% in the Obicetrapib group compared to 12.4% in the placebo group. This underlines the potential of Obicetrapib as a safe alternative for patients not effectively managed by traditional statins.
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with an estimated 17.9 million fatalities annually. Despite the availability of various lipid-lowering treatments, the prevalence of CVD-related deaths continues to rise. Both patients and healthcare providers are in need of new therapeutic options to meet LDL-C targets as many patients are unable to adequately control their levels with existing therapies.
"We are delighted that the results from the BROADWAY and TANDEM studies, along with previously announced findings from the BROOKLYN study, affirm Obicetrapib's ability to significantly lower LDL-C levels and help patients reach their desired targets,” stated Elcin Barker Ergun, CEO of Menarini Group. “Offering a potential best-in-class, low-dose oral therapy is crucial in our ongoing mission to combat cardiovascular diseases in Europe, a challenge we have undertaken for over 30 years."
The global Phase-3 development program for Obicetrapib consists of four pivotal studies encompassing over 12,250 patients. The program aims not only to affirm the LDL-C lowering efficacy of Obicetrapib monotherapy but also to evaluate its role when combined with Ezetimibe. As the recruitment nears completion for several key studies, forthcoming topline data is anticipated to further fortify the clinical standing of Obicetrapib.
In conclusion, Menarini Group's presentation of positive topline data marks a significant milestone in cardiovascular treatment options, demonstrating that Obicetrapib, either alone or in conjunction with Ezetimibe, holds the promise of improving patient outcomes in those at risk for cardiovascular events. As this research advances, the hope is to offer healthcare providers and patients a reliable pathway to achieving better management of cholesterol levels and overall cardiovascular health.
Overview of the Studies
In the BROADWAY trial, involving adult patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherothrombotic cardiovascular disease (ASCVD), the results showed that approximately 50% of patients on Obicetrapib monotherapy achieved LDL-C targets below 55 mg/dL. Furthermore, this study indicated a noteworthy 21% reduction in major adverse cardiovascular events (MACE) over a one-year period for participants receiving Obicetrapib.
In the TANDEM study, which focused on the combination of Obicetrapib and Ezetimibe, over 70% of the patients reached the same LDL-C target. Participants displayed average LDL-C reductions of 48.6% from baseline, reinforcing the combination therapy's effectiveness as a daily, non-statin lipid-lowering option.
Safety and Tolerability
Both trials reported that Obicetrapib, whether administered alone or in combination with Ezetimibe, was well tolerated. Adverse event rates were comparable to those of placebo, indicating no significant safety concerns. The dropout rates due to adverse effects remained low, with only 11.1% in the Obicetrapib group compared to 12.4% in the placebo group. This underlines the potential of Obicetrapib as a safe alternative for patients not effectively managed by traditional statins.
Clinical Importance
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with an estimated 17.9 million fatalities annually. Despite the availability of various lipid-lowering treatments, the prevalence of CVD-related deaths continues to rise. Both patients and healthcare providers are in need of new therapeutic options to meet LDL-C targets as many patients are unable to adequately control their levels with existing therapies.
"We are delighted that the results from the BROADWAY and TANDEM studies, along with previously announced findings from the BROOKLYN study, affirm Obicetrapib's ability to significantly lower LDL-C levels and help patients reach their desired targets,” stated Elcin Barker Ergun, CEO of Menarini Group. “Offering a potential best-in-class, low-dose oral therapy is crucial in our ongoing mission to combat cardiovascular diseases in Europe, a challenge we have undertaken for over 30 years."
Future Prospects
The global Phase-3 development program for Obicetrapib consists of four pivotal studies encompassing over 12,250 patients. The program aims not only to affirm the LDL-C lowering efficacy of Obicetrapib monotherapy but also to evaluate its role when combined with Ezetimibe. As the recruitment nears completion for several key studies, forthcoming topline data is anticipated to further fortify the clinical standing of Obicetrapib.
In conclusion, Menarini Group's presentation of positive topline data marks a significant milestone in cardiovascular treatment options, demonstrating that Obicetrapib, either alone or in conjunction with Ezetimibe, holds the promise of improving patient outcomes in those at risk for cardiovascular events. As this research advances, the hope is to offer healthcare providers and patients a reliable pathway to achieving better management of cholesterol levels and overall cardiovascular health.
Topics Health）
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