Two years ago Rockwell Medical had a tough time convincing investors that its lead drug for iron deficiency anemia had a viable future ahead of it when investigators announced that the treatment had failed a Phase IIb trial. But the biotech came back with some upbeat topline results this morning, sending its shares up sharply.
Researchers for Rockwell said that its PRIME study demonstrated that regular administration of Soluble Ferric Pyrophosphate (SFP)-iron via dialysate reduced the use of erythropoietin stimulating agents--ESAs--during hemodialysis by 37.1% while maintaining iron balance and maximizing iron delivery.
In pre-market trading the biotech's shares shot up 24% as investors pondered the implications for this approach to clearing waste and extra fluid from kidney failure patients.
"We are very excited about the results of this well-run study," said Chief Medical Officer Dr. Raymond Pratt. "The 11 microgram/dL SFP dose delivered sufficient iron without increasing iron stores while greatly reducing ESA dose. The safety profile of SFP was similar to placebo and was well tolerated. In this study, a 37% higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase III CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period."
"We look forward to the upcoming efficacy results from the Phase III CRUISE studies, which are expected to read-out in the second-half of this year," says CEO Robert Chioini.
- here's the press release
- read the Reuters piece