Processa Pharmaceuticals, Inc. announced the dosing of the first patient in the Phase 2 Necrobiosis Lipoidica (NL) clinical trial for PCS-499—which is taking place at 2 sites: University of Pennsylvania and University of Pittsburgh Medical Center (UPMC). Although the main objective of the trial is to evaluate the safety and tolerability of PCS-499 in patients with NL, the safety and efficacy data collected from this study is expected to provide information for the design of future larger clinical trials. NL is a chronic, disfiguring condition affecting the skin and the tissue under the skin typically on the lower extremities with no currently approved FDA treatments. NL presents more commonly in women than in men and ulceration can occur in approximately 30% of NL patients. More severe complications can occur, such as deep tissue infections and osteonecrosis threatening life of the limb. Approximately 74,000 - 185,000 people in the United States and 200,000 – 500,000 people worldwide are affected by NL. The degeneration of tissue occurring at the NL lesion site is caused by a number of pathophysiological changes which has made it extremely difficult to develop effective treatments for this condition. PCS-499 may provide a solution since PCS-499 and its metabolites affect a number of biological pathways, several of which contribute to the pathophysiology associated with NL.