Shots:
- Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3
- Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver volume & improved hemoglobin levels; Sanofi to pursue global regulatory filings
- Venglustat is also being investigated in Fabry disease, where the P-III (PERIDOT) trial showed neuropathic & abdominal pain relief but did not meet the 1EP, while the P-III (CARAT) trial is evaluating effects on left ventricular mass index in men & women
Ref: Sanofi | Image: Sanofi | Press Release
Related News: Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)
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