The phase II study recruited patients with mild to moderate psoriasis, a chronic skin disorder which creates an excess of skin cells that pile up on the skin surface forming lesions. Each participant was treated with the topical vitamin D analogue, becocalcidiol.
The multi-center study involved 185 patients treated for eight weeks, and included three arms: high dose becocalcidiol, low dose becocalcidiol and placebo. Patients at both high and low dose levels demonstrated a statistically significant difference from the placebo group based on the primary endpoint of either clear or near-clear psoriatic lesions.
When given the high dose five times the number of patients reached this endpoint compared with placebo. Patients treated at the high dose level also showed a statistically significant reduction in psoriasis symptom severity and affected body surface area.
Becocalcidiol at both dose levels was well tolerated and adverse events were infrequent. The findings were also consistent with several previous studies indicating that treatment with becocalcidiol did not affect calcium parameters in these patients.
QuatRx owns exclusive worldwide marketing and distribution rights for becocalcidiol as a topical treatment for skin disorders. The company is currently entering into discussions with potential corporate partners in preparation for phase III studies and commercialization of becocalcidiol.