Regeneron Pharmaceuticals (NASDAQ:REGN) announces the successful outcome of a Phase 3 clinical trial, ELIPSE HoFH, evaluating evinacumab in patients with an inherited form of severely elevated levels of “bad” (LDL-C) cholesterol called homozygous familial hypercholesterolemia (HoFH).
The study met the primary endpoint of a statistically significant reduction in LDL-C from baseline to week 24 compared to placebo. Specifically, patients in the treatment group showed a 47% reduction in LDC-C versus a 2% increase in the control arm (p<0.0001). LDL-C reductions were observed at the first assessment at week 2 and were maintained throughout the 24-week treatment period.
On the safety front, 66% of treated patients experienced an adverse event (AE) compared to 81% in the control group. The most common was a flu-like illness (11%) in the treatment arm.
Detailed results will be submitted for presentation at a future medical conference and to regulatory authorities in 2020 beginning with the FDA.
Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3 that plays a key role in lipoprotein metabolism via inhibiting two enzymes called lipoprotein lipase and endothelial lipase. It is also being assessed in patients with refractory hypercholesterolemia and severe hypertriglyceridemia.
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