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PROCESSA PHARMACEUTICALS TO MOVE FORWARD WITH A PCS499 PHASE 3 TRIAL AFTER A SUCCESSFUL FDA MEETING
HANOVER, MD, March 30, 2020 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (OTCQB: PCSA), announced the successful completion of their meeting with the
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"HANOVER, MD, March 30, 2020 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (OTCQB: PCSA), announced the successful completion of their meeting with the U.S. Food and Drug Administration (FDA) for PCS499, its investigational product targeting the treatment of Necrobiosis Lipoidica (NL).\n During the meeting Processa and the FDA discussed the clinical program as well as the nonclinical and clinical pharmacology plans to support the submission of the PCS499 New Drug Application (NDA) in the U.S. for the treatment of ulcers in NL patients. With input from the FDA through a Special Protocol Assessment, Processa will be designing and conducting a Phase 3 trial to evaluate the ability of PCS499 to completely close ulcers in patients with NL. Processa initially planned to begin recruiting for this trial in Q4 2020 but with the COVID-19 pandemic, it is expected that this trial will begin recruiting patients in 2021. FDA will determine if a second confirmatory Phase 3 trial is required after reviewing the results from this first trial. “We are pleased with the outcome of the FDA meeting and the feedback we received from the FDA. We believe that the results from our completed Phase 2 trial in NL patients, especially those with more severe ulcerated forms of NL, are encouraging and we appreciate the guidance provided by the FDA regarding our next clinical trial and the requirements to support our NDA submission. We look forward to working with the FDA in designing a Phase 3 trial that will demonstrate the efficacy and safety of PCS499 for a NDA approval,’” said Dr. David Young, Chief Executive Officer at Processa. NL is a chronic, disfiguring condition affecting the skin and tissue under the skin typically on the lower extremities with no currently approved FDA treatments. 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 more than 200,000 – 500,000 people outside the United States are affected by NL with the prevalence of open ulcers being approximately 30% of all NL patients. 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. At this time there is no approved F...