Processa Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has granted Processa clearance to proceed with a Phase 2 clinical trial of PCS-499 in patients with Necrobiosis Lipoidica (NL) under a recently submitted Investigational New Drug (IND) application.
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.
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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.
"Since there are no approved treatments for this devastating condition, we are pleased that the FDA not only granted PCS-499 orphan designation for NL but also agreed with our proposal to move immediately to Phase 2. We plan to work closely with the FDA to efficiently demonstrate the efficacy and safety of the drug in this patient population," said Dr. David Young, CEO of Processa Pharmaceuticals. "We hope that the IND clearance for the Phase 2 trial represents the first of many milestones for the PCS-499 NL program."