NephroGenex, a drug development firm based in Raleigh, NC, plans to raise $34.5 million in a secondary public offering, according to the Triangle Business Journal. The goal is to increase the number of clinical trial sites to test the company’s drug Pyridorin, a treatment for diabetic nephropathy, commonly stemming from acute kidney injury (AKI) and diabetes.
In its first quarter results, Nephrogenex announced that it aims to expand its Phase 3 clinical trial of Pyridorin to 150 sites worldwide and to file for an Investigational New Drug (IND) Application through the US Food and Drug Administration (FDA). Last February, the company raised $33 million in an initial public offering.
In late December 2014, NephroGenex, announced it had “successfully completed a thorough QT/QTc (TQT) cardiac safety study on Pyridorin.” This study assessed a drug’s risk of QT prolongation and its proarrhythmic potential, and is a standard component of all clinical development programs for new molecular entities. Pyridorin showed no effect on the QT/QTc interval at the expected therapeutic dose of 300 mg and at a quadrupled dose of 1200 mg.
“These are important study results that support the use of Pyridorin in patients with diabetic nephropathy, many of whom suffer from cardiovascular disease,” said Chief Executive Officer Pierre Legault. “They are also important given the concerns over cardiac safety seen with other therapies in development for this disease.”
In March 2015, the company presented a poster session on preclinical findings in an ischemia-reperfusion model in mice that were administered doses of Pyridorin before surgically induced AKI. Pyridorin treatment significantly reduced the level of kidney injury, enhanced renal function recovery, and reduced post-injury fibrosis, the company reported. Treatment with a higher dose of Pyridorin was shown to be even more beneficial in the animals.
“We’re in discussion with the US FDA regarding design of a clinical program in acute kidney injury and anticipate initiating an AKI Phase 1 study during second half of 2015,” Legault said.
In 2014, NephroGenex spent $11.3 million in research and development and $5.3 million on general administrative costs. Cash, cash equivalents, and short-term investments were approximately $28.7 million as of Dec. 31, 2014, compared with approximately $2.1 million as of Dec. 31, 2013.
