Prometic Life Sciences Inc. said that during Phase 2 clinical trials, the company’s lead drug candidate targeting fibrosis, exhibited positive impact on kidneys of patients with diabetes and metabolic syndrome.
Data released by Prometic at the 2017 American Diabetes Association (ADA)’s 77th Scientific Sessions in San Diego, Calif., showed that, after 12 weeks of treatment with PBI-4050, a statistically significant reduction of microparticles shedding from the kidney in the patients’ urine was observed. Furthermore, a statistically significant reduction in key renal biomarkers was also demonstrated in the same patients, according to Prometic.
“Taken together, these data provide strong evidence that PBI-4050 protects the kidney from the injury commonly observed in diabetic patients,” explained Dr. John Moran, chief medical officer at Prometic. “This is supportive of our Phase 2/3 placebo-controlled clinical trial we intend to initiate in the second half of 2017 in patients with late stage chronic kidney disease and diabetes”.
The data presented by the company included results from a Phase 2 clinical trial evaluating PBI-4050 in 24 patients with metabolic syndrome and type 2 diabetes (MST2D), as well as from preclinical studies demonstrating the protective effect of PBI-4050 on the kidney, pancreas, and liver in diabetic animals.
Highlights of the findings were:
- PBI-4050 significantly reduced microparticles shedding from the kidney and key renal biomarkers in diabetic and obese patients
- PBI-4050 prevents diabetic nephropathy and damage to pancreatic cells producing insulin in preclinical diabetic model
- PBI-4050 reduces liver damage and insulin resistance in a high-fat diet preclinical model
“It is quite compelling to see how PBI-4050 reduces damages in the liver, kidney, and pancreas in two new preclinical models which again translates perfectly to what we have observed in the patients in our clinical trial,” said Dr. Gagnon.Lyne Gagnon, vice-president of research and development at Prometic.
PBI-4050 and PBI-4547 are Prometic’s orally active lead drug candidates targeting fibrosis. PBI-4050 will be entering Phase 2/3 clinical trials after demonstrating efficacy and excellent safety profiles in three Phase 2 open-label clinical trials.
Prometic plans to initiate the next phase of clinical trials for PBI-4547 in the fourth quarter of 2017.
Fibrosis is a complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue.
The proof-of-concept data generated to-date with PBI-4050 confirms its anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver, according to the company.
PBI-4050 has on-going clinical trials in patients with metabolic syndrome and type 2 diabetes, cystic fibrosis with related diabetes and Alström Syndrome.