Enrollment concluded early in PCS-499 clinical trial for NL treatment
Category: #health  By Paroma Bhattacharya  Date: 2019-08-28
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Enrollment concluded early in PCS-499 clinical trial for NL treatment

Clinical stage biopharmaceutical firm Processa Pharmaceuticals Inc today announced the last patient to be enrolled in the Necrobiosis Lipoidica (NL) clinical study for PCS-499.

The conclusion of enrollment signifies an important milestone in the development of PCS-499 and is a step ahead for Processa in creating a potential new treatment for patients ailing from NL.

Dr. Sian Bigora, Chief Development Officer of Processa spoke about this achievement, stating that the early enrollment completion is a step closer in providing relief to patients of the disfiguring, chronic disease which is untreatable at present. He expressed the company’s eagerness to getting top-line safety and efficacy data later in 2019 followed by a meeting with the FDA to decide the next stages in attaining product approval.

Dr. David Young, CEO of Processa Pharmaceuticals also commented on the accomplishment adding a note of thanks to the patients and their families as well as the clinical sites who were a part of the study.

According to a previous press release on July 15, a PCS-499 dose of 1.8g per day, which is 50% higher than the maximum tolerated pentoxifylline dosage, was observed to be tolerated well with no reports of adverse events. Additionally, there were several positive efficacy trends observed in the patients participating in this trial.

Necrobiosis Lipoidica is a chronic, disfiguring condition that affects the skin and the tissue underneath the skin, characteristically on the lower extremities. Women are found to be more commonly affected by this condition with ulceration occurring in nearly 30% of patients. More severe symptoms can include deep tissue infections or osteonecrosis, which can be a threat to the limb. NL affects almost 74,000 – 185,000 people across the US and over 500,000 individuals over the world.

Tissue degeneration in NL occurs due to several pathopsychological changes which makes the development of effective treatments challenging. The PCS-499 and its metabolites target numerous biological pathways contributing to NL-associated pathophysiology, which will make it an effective treatment solution for NL patients.

Source credit: https://www.nasdaq.com/press-release/processa-pharmaceuticals-announces-last-patient-enrolled-in-clinical-trial-to-evaluate-the-safety-20190826-00438



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Paroma Bhattacharya

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Paroma Bhattacharya

Paroma currently works as a content developer for Algosonline, MSF and a series of alike platforms. Fortified with a post-graduation degree in Journalism and Mass Communication, she delved head long into a writing career, creating resourceful and information enriched ...

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