BioStratum’s lead drug, which recently received “Fast Track” status from the FDA, is performing well in the first of three Phase II trials, the company reported Monday.
Results were disclosed at the BIO 2003 convention in Washington, DC.
Pyridorin is designed for treatment of diabetic kidney disease. The drug inhibits formation of so-called glycation end-products, which are considered to be a cause of diabetic complications such as kidney disease, blindness and nerve damage.
According to BioStratum, kidney disease affects up to 40 percent of people who are afflicted with type 1 or type 2 diabetes.
Some 128 patients suffering from type 1 or type 2 diabetes and kidney disease received either Pyridorin or placebo as well as additional standard care. The company said the drug was “safe and well tolerated”, that “there were no treatment-related serious adverse events” and the progression of the kidney diseases “was decreased in a statistically significant manner.”
“The results from this Phase II clinical trial are extremely encouraging and support BioStratum’s belief that Pyridorin will be safe and effective in the treatment of diabetic nephropathy,” said Robert Schotzinger, president and chief operating officer of BioStratum, in a statement.
The company said it expected to release more study results in November.