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

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



About Author

Paroma Bhattacharya

Email: [email protected]   

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 ...

Read More

More News By Paroma Bhattacharya

Poxel releases detailed Imeglimin Phase 3 results from TIMES 1 program
Poxel releases detailed Imeglimin Phase 3 results from TIMES 1 program
By Paroma Bhattacharya

Type 2 diabetes is a prevailing disease in which cells become unresponsive to insulin while gradually increasing blood sugar. With growing cases of Type 2 diabetes worldwide, pharmaceutical companies are now focusing o...

Poxel commences its Phase 1b trial for NASH drug candidate, PXL065
Poxel commences its Phase 1b trial for NASH drug candidate, PXL065
By Paroma Bhattacharya

Nonalcoholic steatohepatitis (NASH) is liver inflammation caused by the buildup of fat in the liver mostly with people who drink little or no alcohol. With growing cases of NASH prevailing worldwide, pharmaceutical com...

Flipkart extents delivery reach by 80% to cover more pincodes in India
Flipkart extents delivery reach by 80% to cover more pincodes in India
By Paroma Bhattacharya

  • The e-commerce site has managed to grow its reach to an estimate of 19,200 PIN codes from its prior 10,660 last year for the delivery of huge appliances.