At the European Society of Cardiology (ESC) 2024 meeting, Dr. Erin Michos highlighted the success of the obicetrapib trials to date. NewAmsterdam has shown promising data in all Phase II trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as a monotherapy or combination therapy, with the ability of obicetrapib to statistically reduce low-density lipoprotein (LDL).
The completion of the Phase III TANDEM trial enrollment is a step towards the potential launch of obicetrapib, bringing NewAmsterdam closer to providing a new treatment option for heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD). If successful, the results from the TANDEM trial could lead to a new treatment option for patients struggling with high cholesterol, particularly those who do not respond to current therapies.
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Currently, no therapies specifically targeting lipoprotein a or Lp(a) are available on the market. Standard dyslipidemia treatments, such as statins and other cholesterol-lowering medications, do not effectively reduce Lp(a) levels. This creates a significant need for new drugs that can specifically target and lower Lp(a) in the blood. While a few strategies, such as PCSK9 inhibitors, have been shown to reduce Lp(a) levels by up to 30%, these newer drugs are costly and generally reserved for patients who cannot tolerate statins or who have exceptionally high cholesterol levels. Cholesteryl ester transfer protein (CETP) inhibitors lower Lp(a) levels by blocking the transfer of cholesterol esters from high-density lipoprotein (HDL) to apo(a)-containing lipoproteins. This mechanism reduces the formation of Lp(a) particles in the bloodstream. The current pipeline CETP inhibitor obicetrapib, developed by NewAmsterdam Pharma, has demonstrated a 57% reduction in Lp(a) levels. Dr. Michos expressed optimism, saying, “The potential for a treatment that can lower both LDL and Lp(a) is very promising.”
GlobalData key opinion leaders have also highlighted the current unmet need for therapies that specifically target Lp(a). According to GlobalData, NewAmsterdam’s therapy has the potential to address the treatment gap and is projected to be the most promising agent in the dyslipidemia market by 2032. Obicetrapib is forecast to achieve the highest pipeline drug sales across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), with estimated sales reaching $1.40bn by 2032.
