Benzinga | May 20, 2021 04:07PM EDT

Processa Pharmaceuticals Announces First Patient Dosed in its Randomized Double-Blind, Placebo-Controlled Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), ("Processa" or the "Company"), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, today announced it has dosed its first patient in the Processa trial to evaluate PCS499 in treating ulcerations in patients who have Necrobiosis Lipoidica (NL). NL is a rare, chronic, idiopathic, granulomatous disease of collagen degeneration caused by a number of very diverse pathophysiological changes in a patient. In approximately 30% of NL patients, an open ulcer forms that can have a significant impact on a patient's quality of life.

Sian Bigora, Pharm.D., Chief Development Officer said "The incidence of ulcer closure as assessed by skin examination in patients treated with PCS499 as compared to placebo will be a true indication of what PCS499 can do for patients who currently have no treatment options available for the disease. We are excited to have randomized the first patient in this Phase 2B trial."

The Principal Investigator for the trial is Dr. Misha Rosenbach. The present site Principal Investigators are Dr. Misha Rosenbach, Dr. Adeel Ahmad, Dr. Afsaneh Alavi, Dr. Walter Nahm and Dr. Todd Schlesinger. The first patient was dosed by Dr. Schlesinger at the Clinical Research Center of the Carolinas.