Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, has dosed its first patient in its PCS499 trial; the dosing took place at the Clinical Research Center of the Carolinas. The trial, which is currently enrolling patients, is designed to study and evaluate PCS499 in treating ulcerations in patients who have necrobiosis lipoidica (“NL”). NL is a rare, chronic disease of collagen degeneration, which can be caused by a variety of pathophysiological changes in a patient. The announcement noted that 30% of NL patients develop an open ulcer, which can have a significant impact on quality of life. The Principal Investigator for the trial is Dr. Misha Rosenbach. Investigators involved in the study include Dr. Misha Rosenbach, Dr. Adeel Ahmad, Dr. Afsaneh Alavi, Dr. Walter Nahm and Dr. Todd Schlesinger, who dosed the first patient. “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,” said Pharm.D. chief development officer Sian Bigora in the press release. “We are excited to have randomized the first patient in this phase 2B trial.”
To view the full press release, visit https://ibn.fm/yWifo
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 clinical 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 about the company, visit www.ProcessaPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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