This multi-center, randomized, double-blind, vehicle-controlled, parallel group study was designed to assess the safety and preliminary efficacy of two dose levels of topical PTH (1-34) for the treatment of mild to moderate plaque psoriasis.
While the study did achieve the primary safety objective, the data did not demonstrate a statistically significant improvement in the overall disease severity of treatment lesions or signs and symptoms of psoriasis as compared to the vehicle (placebo) gel.
Topical PTH (1-34) appeared to be well tolerated with no hypercalcemia or serious adverse events reported. Manhattan Pharmaceuticals intends to further analyze and asses these data in order to determine appropriate next steps for the program.