Inecalcitol: Phase II data
Top-line data from a double-blind, French Phase II in 57 evaluable patients with moderate to severe psoriasis showed that once-daily 4 mg oral inecalcitol for 16 weeks missed the primary endpoint of a greater proportion of patients achieving a PASI response vs. placebo. Specifically, 65% of patients receiving inecalcitol (n=37) achieved a PASI 50 response and 27% achieved a PASI 75 response at week 12 or at week 16. Detailed data for the placebo arm were not disclosed. However, Hybrigenics said there was an unexpectedly strong improvement in women who received placebo, with 63% achieving a PASI 75 response compared to 17% of placebo-treated men.
Additionally, parathyroid hormone (PTH) levels in patients receiving inecalcitol were significantly reduced by >50% from baseline during the 16-week treatment period, while PTH levels in patients receiving placebo remained within the normal range (p<0.0001). Hybrigenics said PTH levels fell below the normal range in 34 inecalcitol-treated patients and below the limit of quantification in 24 patients. However, the company said PTH levels in inecalcitol-treated patients returned to within the normal range after 1 month of follow-up. ...