BA058-transdermal: Phase II data
Top-line data from a double-blind, international Phase II trial in 250 postmenopausal women with osteoporosis showed that once-daily 50, 100 and 150 µg doses of transdermal abaloparatide applied to the skin and removed after 5 minutes each met the primary endpoint of increasing BMD at lumbar spine from baseline to 6 months vs. placebo. Radius said high-dose transdermal abaloparatide led to the greatest increase in lumbar spine BMD with a 2.95% increase vs. 0.04% for placebo (p<0.0001). Both mid- and high-dose transdermal abaloparatide also significantly increased total hip BMD from baseline to 6 months vs. placebo. Specifically, high-dose transdermal abaloparatide led to a 1.49% increase in total hip BMD vs. a 0.02% reduction for placebo (p=0.0018). Additionally, a once-daily 80 µg dose of subcutaneous abaloparatide led to a 5.8% increase in lumbar spine BMD and a 2.74% increase in hip BMD from baseline to 6 months. All doses of both transdermal and subcutaneous abaloparatide were well tolerated with no treatment-related adverse events reported. ...