BioStratum says new human safety and efficacy data on its lead drug candidate, Pyridorin, is positive and that the company is seeking a commercialization partner for the diabetic kidney disease treatment.
Pyridorin, a small molecule that inhibits the formation of harmful advanced glycation end-products that lead to kidney disease and other problems, has been granted Fast Track status by the FDA and has recently completed Phase II clinical trials for the treatment of diabetic kidney disease.
Robert Schotzinger, the president and chief executive officer of RTP-based BioStratum, recently discussed Pyridorin during a presentation made at the BIO CEO & Investor Conference being held in New York City.
In his presentation, Schotzinger provided initial findings from two six-month Phase IIb trials of Pyridorin that involved a total of 84 patients with either type 1 or type 2 diabetes and either mild-to-moderate or moderate-to-severe diabetic nephropathy. He said the trial results suggest that Pyridorin may be safe and effective in the treatment of diabetic nephropathy and that it was safe and well tolerated.
“The results from these Phase IIb clinical trials are extremely encouraging and support the results from study — reported last year,” said Schotzinger. “With three completed Phase II studies in-hand, BioStratum has now compiled a compelling package of safety and efficacy data which supports the initiation of the Pyridorin Phase III program–.”
As Pyridorin moves into the later stages of clinical development, BioStratum is actively seeking a commercial partner, which would fund the Phase III trials and eventually sell the drug if approved. The company says it also hopes to acquire other clinical-stage drug candidates for the treatment of diabetic complications to further strengthen its pipeline.
BioStratum: www.biostratum.com
