Renal drug developer Rockwell Medical (RMTI) tried hard to put a positive spin on new Phase IIb data for its lead renal drug therapy, but its failure to hit the primary efficacy endpoint for the treatment of iron deficiency anemia clawed a big chunk out of the company's share price this morning.
"We're very pleased by the Phase II results," insisted CEO Robert Chioini in a conference call with analysts this morning. The drug--dubbed SFP--demonstrated safety in the trial and also delivered the insight into the therapy that the company needed to design and conduct a Phase III trial, now scheduled to launch in the third quarter.
The primary efficacy target, though, was a minimum 1 gram decrease in baseline in hemoglobin, and the data missed that target. The company cited a variety of issues for the endpoint failure, including a group of placebo patients who were more iron-loaded than SFP patients and ESA dose changes that violated the trial protocols.
The drug is intended to treat or prevent iron deficiency anemia, traveling to the bloodstream and avoiding the liver and reticuloendothelial system and delivering iron much the way healthy people gain iron from their daily diet. Wixom, MI-based Rockwell, which raised $22 million from a stock sale last fall, says that it plans to push ahead into Phase III in the third quarter. Investors weren't quick to buy into the upbeat talk, though. Its stock plunged 26 percent in pre-market trading.
- check out Rockwell's release
- here's the report from Reuters