Long road ahead for non-statin therapies in Australia dyslipidemia treatment space: GlobalData

Esperion Therapeutics’ non-statin therapy “bempedoic acid” has shown modest results in reducing the risk of major cardiovascular events in statin-intolerant patients in the cholesterol-lowering via bempedoic acid, an ACL-inhibiting regimen (CLEAR Outcomes) trial. As a result, there is substantial room for improvement in this space as a potential approval is expected in Australia in the near-term based on these results, says GlobalData.

According to GlobalData’s Pharmaceutical Intelligence Center, the total number of diagnosed prevalent cases of dyslipidemia in Australia is expected to increase at a compound annual growth rate of approximately 1.2 per cent from 5.2 million in 2022 to 5.4 million in 2025.

Neha Myneni, Pharma Analyst at GlobalData, comments, “Bempedoic acid joins several statin alternatives that have shown the potential to reduce cardiac illnesses. However, with not much significant improvement in the outcomes, there exists a clear room for improvement for non-statin therapies in this space.”

CLEAR Outcomes is a global trial that was conducted in 32 countries, (including over 300 Australian patients with high cholesterol) for four years to assess the efficacy of bempedoic acid in reducing the risk of cardiovascular events in statin-intolerant patients. As per the study results, bempedoic acid lowered low-density lipoprotein (LDL) by 20-25 per cent (where statins can reduce these levels by as much as 50 per cent when used in high doses); cardiovascular complications by 13%; heart attack by 23 per cent; and coronary revascularisations by 19 per cent.

Bempedoic acid is the sixth class of cholesterol-lowering drugs (other than cholesteryl-ester transfer protein isoform (CETPi) inhibitors), that has demonstrated the potential to reduce heart attacks and strokes. Other class of therapies with similar potential currently marketed in Australia include statins, bile acid resins, niacin, ezetimibe, and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (alirocumab, evolocumab, and inclisiran).

CETPi inhibitors are example of a failed class of therapy for statin-intolerant patients. Till date, four CETPi inhibitors (Pfizer’s torcetrapib; Merck’s anacetrapib; Roche’s dalcetrapib; and Lilly’s evacetrapib) reached Phase III cardiovascular outcome trials. However, further development of all these molecules was discontinued due to their insufficient cardiovascular benefit for regular use.

Myneni concludes, “With a potential to address about 100,000–500,000 statin-intolerant patients in Australia, bempedoic acid, however, may not be considered an alternate to statin therapy at this juncture with only moderate improvement in LDL lowering efficacy and reduction in cardiovascular risk. Further trials comparing the efficacy of bempedoic acid head-on with statins or other established therapies in future could prove its efficacy in LDL treatment.”