ProMetic Life Sciences recently announced positive results in its ongoing, open-label, Phase 2 clinical trial, “Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome,” where the team analyzed novel pro-inflammatory biomarkers in urine and blood samples from patients. The results provided further evidence of PBI-4050’s beneficial effects in humans.
In December 2015, the Canada-based company reported the statistical and clinical significance of the HbA1C decrease (a measure of the average blood glucose) observed in the initial 11 patients who enrolled and finished the 12-week study. In general, participants experienced enhanced blood glucose control as defined by HbA1C (with an average decrease of -0.6 percent), with 10 of the 11 patients seeing a decrease in HbA1C.
In patients with HbA1C values higher than 7.5 percent at screening, this decrease surpassed 1 percent, a performance that puts PBI-4050 in a favorable position compared to other drugs marketed and approved to treat diabetes.
“This additional data provides additional evidence of PBI-4050’s pharmacological activity in humans,” said ProMetic Chief Medical Officer Dr. John Moran in a press release. “We were, of course, impressed with the improvement in HbA1c when PBI-4050 was added to standard oral antidiabetic medications. We now have evidence that the drug may provide additional clinical benefit by protecting the kidney and heart. Moreover, PBI-4050 has demonstrated a very good safety and tolerability profile, with no drug-related serious adverse events.”
The assessment of new biomarkers in the enrolled patients revealed that high measurements of particular biomarkers commonly associated with an elevated risk of cardiovascular events were significantly reduced by the drug’s action. Patients’ blood levels of pentraxin-3 and resistin – both biomarkers linked to high risk of cardiovascular complications in patients suffering from metabolic syndrome – were also reduced by PBI-4050.
Additionally, IL-18 – a biomarker linked to renal and cardiovascular complications in patients with metabolic syndrome – similarly demonstrated a reduction that was statistically significant.
ProMetic will supplement its upcoming filings to the U.S. FDA and Health Canada with updated clinical information collected in the trials, with the intention of filing FDA Investigational New Drug applications for PBI-4050 in chronic kidney disease and type 2 diabetes, and also in idiopathic pulmonary fibrosis.
“We expect PBI-4050 to perform as well in patients with chronic conditions with an underlying progressive fibrotic process,” said Pierre Laurin, ProMetic’s president and CEO. “Our clinical program, including patients affected with Alström Syndrome, scleroderma, cystic fibrosis, lung fibrosis, and chronic kidney disease, is designed to leverage PBI-4050’s outstanding performance in multiple preclinical models of either diabetes or fibrosis or both and this most recent positive data in patients with type 2 diabetes and metabolic syndrome.”