Processa Pharmaceuticals (NASDAQ: PCSA), 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 announced that it has selected five U.S. clinical sites to enroll patients with ulcerative necrobiosis lipoidica for the company’s Phase 2B trial. In addition, two to three more clinical sites will be selected for the 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.” “We have selected five U.S. sites to evaluate this groundbreaking 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.,” said Dr. Sian Bigora, chief development officer at Processa. “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 preliminary clinical evaluation of PCS499 in the treatment of patients with ulcerative necrobiosis lipoidica suggests that PCS499 may be effective in closing these ulcers within months of starting treatment.”
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About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active pipeline programs include: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). The members of the Processa development team have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.ProcessaPharma.com.
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