Sanofi Gaucher's therapy meets Phase III endpoints

Sanofi (Euronext:SAN; NYSE:SNY) and its Genzyme Corp. subsidiary said twice-daily eliglustat tartrate met the primary endpoint of reducing spleen volume from baseline to nine months vs. placebo in the Phase III ENGAGE trial to treat Type I Gaucher's disease (28% vs. a 2% increase, p<0.0001). Eliglustat tartrate also met all secondary endpoints, including improving hemoglobin levels, platelet levels and liver volumes vs. placebo. Genzyme said that initial safety data suggest that eliglustat tartrate was well tolerated, with no serious adverse events reported and no clinically meaningful differences in treatment-related adverse events reported between the two arms. The product is a ceramide analog that inhibits glucosylceramide synthase (GCS). The double-blind, international trial enrolled 39 evaluable patients. ...