Commercial-stage biotech Amarin Corporation ( NASDAQ: AMRN ) announced on Thursday that serum samples of patients treated with its heart disease drug icosapent ethyl (IPE) had only limited differences in certain biomarkers compared to those who received a placebo.
Previous data has indicated that benefits of IPE was derived from eicosapentaenoic acid (EPA) levels in REDUCE-IT trial.
The global cardiovascular outcomes study had demonstrated a 25% risk reduction of major adverse cardiovascular events (MACE) for the treatment known commercially as VASCEPA/VAZKEPA.
While there was a strong relation between the reductions of MACE and serum EPA levels, the data from the sub analysis demonstrated that there were “relatively small changes in inflammatory markers between icosapent ethyl and placebo,” the company said.
The exploratory post hoc sub-analysis of REDUCE-IT study was funded by Amarin ( AMRN ) under a research grant. The results were published online in the journal Circulation on Thursday.
Commenting on the biomarkers, the lead investigator of REDUCE-IT trial, Deepak L. Bhatt said: “…the absolute magnitude of these differences is too small to explain the substantial reduction in clinical events seen in the REDUCE-IT trial, which is most likely due to the approximate 400% increase in EPA levels.”
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Amarin says heart disease drug linked to only limited differences of key biomarkers