Ionis Reports P-III Study (Balance) Results of Olezarsen for Familial Chylomicronemia Syndrome
Shots:
- The P-III study evaluating olezarsen (80 or 50mg) vs PBO via SC inj., q4w for 53wks. in a ratio (1:1:1) in 66 patients aged ≥18yrs. The trial met its primary efficacy EPs with a reduction in triglyceride levels with olezarsen (80mg monthly dose) at 6mos.
- Triglyceride lowering continued to improve at 12mos., 100% reduction in acute pancreatitis events & >75% in apoC-III. Dose-dependent effect with both study doses showed a reduction in pancreatitis
- 50mg dose did not reach statistical significance at 6mos. on 1EPs of triglyceride-lowering & demonstrated a favorable safety & tolerability profile with no hepatic or renal toxicity events & no clinical platelet reductions. The company plans to file an NDA in early 2024 with the US FDA
Ref: PR Newswire | Image: Ionis
Related News:- Ionis Initiates P-III CORE Study of Olezarsen for the Treatment of Severe Hypertriglyceridemia
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