Business
Processa Announces Sites Selected for Phase 2B Clinical Trial to Treat Patients with Ulcerated Necrobiosis Lipoidica
HANOVER, March 17, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"HANOVER, March 17, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, today announces that it has selected 5 U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica for the Company’s Phase 2B trial “A Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients who Have Necrobiosis Lipoidica.” Two to three additional clinical sites will be selected in the future including sites outside the U.S. Dr. Misha Rosenbach, Department of Dermatology at the University of Pennsylvania, is the Principal Investigator on the study. A summary of the study and a listing of the sites selected can be found at https://clinicaltrials.gov using the NCT number of NCT04800562. The study is expected to begin recruiting patients within the next 30-60 days. Necrobiosis Lipoidica (NL) is a rare, painful condition affecting the skin and tissue under the skin typically on the lower extremities. Ulcerations occur in up to 35% of patients with NL, many times following minor trauma. Ulcerations often prove challenging to treat and may lead to more severe complications, such as deep tissue infections and osteonecrosis that can threaten the life of the limb and lead to amputation. The ulcers run a refractory course and usually are resistant to treatment. The ulcers in NL can be painful leading to impaired quality of life for these patients. The pathogenesis of NL remains unclear and although various drugs have been tried, none of them is consistently effective. PCS499 and its metabolites affect a number of biological pathways, several of which contribute to the pathophysiology associated with ulcerative NL. “We have selected 5 US sites to evaluate this ground-breaking new treatment for ulcerative necrobiosis lipoidica and we expect to add a few more sites in the next few months including sites outside the U.S. Unfortunately for patients with ulcerative necrobiosis lipoidica, open ulcers often take years to naturally heal, if they heal at all, and treatments to close the ulcers in these patients do not exist. Fortunately, our pre...