Rockwell Medical shares surged early today after the biotech announced that its second, duplicate Phase III study for a new iron-delivery drug hit its primary and secondary endpoints, setting the stage for a new drug application.
Investigators say that SFP compared to a placebo nailed a statistically significant mean change in hemoglobin from baseline to end-of-treatment for chronic kidney disease patients receiving hemodialysis. Key secondary endpoints included maintenance of hemoglobin, maintenance of reticulocyte hemoglobin and an increase in serum iron pre-to-post treatment without an increase in ferritin. And the Wixom, MI-based biotech's CEO says that the company is on track to provide a new standard of care in the field.
"We are perfectly built to succeed in the dialysis market," CEO Rob Chioini told analysts in a conference call this morning. And execs added that an NDA would be filed in the next four to 6 months.
The company's stock ($RMTI) swiftly jumped about 13% on the news.
The new data builds on evidence from a study in February that SFP--soluble ferric pyrophosphate--reduced the need for expensive ESA therapy to build red blood cells in patients, helping build an economic argument for payers. And there was no difference between their drug and a placebo when it came to the safety profile, according to investigators.
"The data again shows that in place of IV iron, SFP appears safe and effective as an iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores," Chioini said in a statement. "The demonstrated efficacy and excellent safety data from each of the two Phase III CRUISE efficacy studies gives us great confidence in obtaining FDA regulatory approval. These successful results, coupled with the recent positive PRIME study data demonstrating SFP's ability to significantly reduce ESA use, support our belief that SFP will establish a new paradigm in iron therapy treatment for hemodialysis patients. We believe that upon FDA approval, SFP will become the new standard of care in iron therapy."
- here's the press release