HANNOVER, MD, Aug. 04, 2022 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve survival and/or or the quality of life of patients with unmet medical needs, today announced the launch of a new website, Necrobiosislipoidicastudy.com. The website is designed to increase awareness of ulcerative necrobiosis lipoidosis (“uNL”), an extremely rare disease, and to inform patients of the ongoing Phase 2 study investigating the use of PCS499 for the treatment of this rare disease.
Necrobiosis lipoidica (NL) is a chronic skin condition with no treatment currently approved by the United States Food and Drug Administration (FDA). NL is thought to affect 22,000 to 50,000 people in the United States and is more common in people with diabetes and women, with an average age of onset between 20 and 60 years old. People with NL have a persistent skin condition that develops into ulcerative lesions in about a third of cases. Ulceration can lead to serious complications, such as life-threatening infections and necrosis.
Processa Pharmaceuticals is conducting a randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of PCS499 versus placebo for the treatment of ulcerations in patients with necrobiosis lipoidosis (NCT#NCT04800562). This study is currently recruiting in the United States and is expected to enroll a total of 20 patients.
Sian Bigora, Pharm.D., Director of Development, said, “For patients with NL, the tissue under the skin can become necrotic and form open ulcers that can last for months to years with complications such as infections, amputations and cancers. Currently, there are no FDA-approved treatments for uNL or NL, no standard of care, and the treatments used are generally inadequate. We are conducting the Phase 2b study to hopefully show that PCS499 may be an option for those patients who currently have few or no options available.”
For more information on the clinical study of PCS499, please visit Necrobiosislipoidicastudy.com
PCS499, is a deuterated analog of a major metabolite of pentoxifylline (PTX or Trental®). PCS499 and its active metabolites have a diverse pharmacological profile and can act on multiple targets that play a vital role in the treatment of various conditions. The researchers postulate that PCS499 could provide a novel treatment solution for NL through its metabolites, which affect many biological pathways that contribute to physiological processes associated with NL.
About process Pharmaceuticals, Inc.
Processa’s mission 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 selection criteria 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 lipoid necrobiosis) and PCS12852 (gastroparesis). Members of Processa’s development team have participated in more than thirty FDA drug approvals (including drug products targeted at orphan diseases) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.processapharma.com.
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements that involve risks and uncertainties. Actual future performance and results may differ materially from those expressed in forward-looking statements. Please refer to Processa Pharmaceuticals’ filings with the SEC, in particular the most recent reports on Forms 10-K and 10-Q, which identify material risk factors that could cause actual results to differ from those contained in forward-looking statements.
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