—Rockwell Medical, based in Wixom, MI, last week announced successful results from its Phase 3 trials of Soluble Ferric Pyrophosphate (SFP), an iron salt administered to dialysis patients through dialysate to replace the iron lost during dialysis. The data showed that in dialysis patients not receiving IV iron, SFP effectively delivers iron via dialysate and maintains hemoglobin without increasing stored iron (ferritin). There was also strong safety data demonstrating no anaphylactic or hypersensitivity events and no increase in hypotension or infection.
Rockwell’s innovation is the method of SFP delivery. Because it passes to patients as part of the dialysis process, it mimics the way dietary iron is processed by the human body, according to CEO Rob Chioini. Chioini says the company is prepared to disrupt the market with a product that will significantly decrease the need for expensive erythropoietin stimulating agents (ESAs), drugs that treat anemia in kidney dialysis patients.
This long-term study is the first of two identical Phase 3 efficacy trials required before the company can file a new drug application with the FDA. Results from the second Phase 3 study will be released in the fall.
—The Kalamazoo, MI-based company Metabolic Solutions has published data in the scientific journal PLOS ONE on a new drug target for type 2 diabetes located in the inner mitochondrial membrane. This new drug target, called mTOT, functions as a “sensor switch,” controlling metabolic processes that are out of balance in patients with type 2 diabetes, such as the processing of carbohydrates, lipids, and amino acids.
Stephen Benoit, CEO of Metabolic Solutions, says the company has completed Phase 2b trials on MDSC 0160, and is now redirecting it for use in patients with Alzheimer’s and Parkinson’s Disease. With funding from the Michael J. Fox Foundation, Metabolic Solutions has been able to “really drill down into the mechanism of how the drug works.”
“We should be able to move the first of our compounds into the clinic by the end of 2014,” Benoit adds.
Metabolic Solutions is also preparing for a Phase 2b trial of a second diabetes drug, called MSDC 0602, that Benoit says can control glucose in insulin-sensitive patients without side effects. Benoit says Metabolic Solutions is pursuing fundraising to continue to move these drugs to market.
