Summary:
ESPR first announced Clear Outcomes Nexletol data in Dec 2022, but only stated the primary endpoint was met
They reported that full data would be presented at ACC on March 4
Here we present background info on what this data will include
See the full Amp view on this upcoming data in our forum post for subscribers. To subscribe learn more here. Contact support if you are currently a BPIQ subscriber.
ESPR - Nexletol data
In this article we will provide factual info about the previous Nexletol trial data and the upcoming CLEAR outcomes data coming on March 4 at ACC. This data will include results regarding major adverse cardiovascular events (MACE-4) data from the Outcomes trial. Esperion already stated that NEXLETOL (bempedoic acid) is the first ATP citrate lyase inhibitor to meet the primary endpoint for this type of trial, but currently no actual data has been reported. See Figure 1 for the study design of the CLEAR outcomes study, and the primary and secondary endpoints to be presents.
FIG. 1
Nexletol (bempedoic acid) was approved in February 2020 for LDL lowering in HeFH (heterozygous familial hypercholesterolemia) based on Phase 3 data reported in October 2018. In Oct 2018 the Phase 3 LDL-C lowering program was completed and achieved safety and tolerability objectives. Bempedoic acid achieved additional 18%-31% LDL-C lowering in patients on maximally tolerated statins. The MACE events in the bempedoic acid arm were all lower than in the placebo arm. The NDA was submitted in Q1 2019, and approved Feb 21, 2020.
HeFH is characterized by elevated LDL cholesterol and the upcoming outcomes trial data will provide results of adverse cardiac events in patients treated long term with Nexletol vs placebo. The primary endpoint is a MACE-4 composite endpoint: the time to first cardiovascular death, nonfatal myocardial infarction, non-fatal stroke, or coronary revascularization.
Other LDL Lowering Commercial Assets
While we already know the CLEAR outcomes trial met the primary endpoint, the important data coming at ACC in March will be how it compares to Outcomes data from other LDL lowering commercial assets. This is what is most likely to move ESPR's stock. Currently, approved products for LDL lowering include MRK's Zetia, REGN & SNY's Praluent, and AMGN's Repatha. See Table 1 for info on these assets as well as the primary and secondary endpoint data from each asset's Outcomes Trial. Praluent and Repatha both treat HeFH and are PSK9 inhibitors, Zetia treats HoFH and is a selective cholesterol absorption inhibitor.
Table 1. Comparison of recent Outcomes Trials for LDL lowering commercial assets
To see Amp's view on this upcoming readout, see our full forum after subscribing, learn more here. Contact support if you are currently a BPIQ subscriber.
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