problems. More effective triglyceride-lowering approaches are needed to treat FCS patients," said Daniel Gaudet
, M.D., Ph.D., from the department of medicine, University of Montreal and scientific director, Genome Quebec Biobank Technology Center. "ISIS-APOCIIIRx
has been shown to be a robust triglyceride-lowering agent in patients with moderately high to severely high triglycerides in multiple Phase 2 settings. These data presented today, although collected in a small number of patients, are also compelling and demonstrate the potential of ISIS-APOCIIIRx
to produce dramatic triglyceride lowering in patients with FCS. Based on the comprehensive Phase 2 data for ISIS-APOCIIIRx
, I am extremely encouraged about the therapeutic potential for ISIS-APOCIIIRx
in patients with severely high triglycerides, especially for use in FCS patients who have very limited therapeutic options."
The Phase 2 open-label cohort was designed to assess the safety and activity of ISIS-APOCIIIRx in patients with severely high triglyceride levels (greater than 440 mg/dL) and a genetic confirmation of FCS. The data reported today is an analysis of the three FCS patients in the study all of whom had baseline triglyceride levels greater than 1,400 mg/dL and had completed 13 weeks of treatment with 300 mg of ISIS-APOCIIIRx. In this study, all three patients treated with ISIS-APOCIIIRx achieved substantial reductions in triglyceride levels with an average reduction of 69 percent. In addition, these patients experienced positive effects on other lipid parameters, including HDL-C, apoC-III and apoC-III-associated VLDL-C. Because FCS is an extremely rare genetic disorder affecting one to two people per million, clinical trials in this disease are generally quite small.
Table 1: ISIS-APOCIIIRx Produced Substantial
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