ProMetic Life Sciences Inc., a biopharmaceutical company focused on the development of small-molecule drugs and plasma-derived therapeutics, recently presented new data on its product PBI-4050 for fibrosis treatment at the European Renal Association (ERA)-European Dialysis and Transplant Association (EDTA) Annual Meeting held in London, United Kingdom, May 28 to 31. The data was presented in two posters entitled “Oral treatment with PBI-4050 reduces kidney fibrosis” and “PBI-4050 protects against renal and pancreatic fibrosis in type 2 diabetes.”
PBI-4050 is an oral drug candidate that targets fibrosis, a process characterized by the replacement of normal tissue by fibrotic scar tissue. Fibrosis usually occurs as the result of a chronic inflammation and it can impair the function of vital organs. PBI-4050 has been shown to be safe and well-tolerated in healthy volunteers and patients with chronic kidney disease, and to have anti-fibrotic activity in several key organs including the lungs, heart, liver and kidneys.
Researchers have conducted in vitro experiments with normal human dermal fibroblasts and human kidney cells in which fibrosis was induced to assess the efficacy of PBI-4050. The team found PBI-4050 was able to regulate pro-fibrotic growth factors and remodeling enzymes in both cell types, similar to what had been observed in animal models, which could ultimately explain its effects in improving kidney function.
PBI-4050 was also assessed as a therapy in mice models of diabetes. Researchers found that PBI-4050 treatment resulted in improved hyperglycemia, preserving insulin production, and most importantly, that it prevented both pancreas and kidney fibrosis.
“This is very important data because it confirms that the anti-fibrotic mechanism of action of PBI-4050 is similar in humans and in animals,” noted the Chief Medical Officer of ProMetic, Dr. John Moran in a news release. “These results provide further support for our belief that the efficacy of PBI-4050 demonstrated in multiple preclinical models will translate into clinical benefit in patients suffering from fibrotic diseases such as idiopathic pulmonary fibrosis or chronic kidney disease associated with diabetes.”
“Our data correlates the regulation activity of PBI-4050 on key fibrotic biomarkers and the resulting improved kidney function. In fact, we have observed this in all major organs including the pancreas, liver, lungs and heart,” added the Head of R & D, Preclinical Research at ProMetic Dr. Lyne Gagnon.
PBI-4050 is currently being evaluated in phase II clinical trials in patients with idiopathic pulmonary fibrosis (IPF), a progressive fatal lung disease in which the alveoli and the lung tissue become thick and scarred (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. There is no cure for IPF and it is estimated that 128,000 individuals in the United States suffer from the disease. IPF has a poor prognosis and around two-thirds of the patients die within five years after being diagnosed. Effective therapies for pulmonary fibrosis are therefore urgently needed.