Rockwell Medical, Inc., a fully-integrated biopharmaceutical company targeting ESRD and CKD, has completed its large-scale, long-term safety study. This final phase III study and the two CRUISE clinical efficacy and safety studies were conducted in support of the New Drug Application (NDA) for marketing approval of Triferic.

Triferic is the company's late-stage investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

"We are thrilled to have achieved this significant milestone event," stated Robert L Chioini, founder, chairman and CEO of Rockwell. "The phase III clinical programme is now complete and we are focused on filing our NDA with the FDA in the near-term. This drug's unique mode of action, its delivery via dialysate and efficient iron delivery directly to the bone marrow, enables it to be used immediately, like dietary iron, and maintain hemoglobin while significantly reducing the need for ESA. These clinical benefits highlight its potential to be the market-leading iron therapy treatment for CKD-HD patients."

"We continue to be impressed with Triferic and its safety profile," stated Dr Raymond Pratt, CMO of Rockwell. "Our clinical programme is easily the largest and longest cohort of any parenteral iron drug. We have dosed Triferic in over 100,000 separate administrations and we have not identified an acute safety signal or anaphylactic reaction. This additional safety data, coupled with the successful phase III CRUISE studies and ongoing open-label study, gives us great confidence that Triferic can provide dialysis patients a safe, effective maintenance iron therapy."

These safety studies were the continuation of the CRUISE efficacy trials and Study SFP-6, a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, phase III study with an enrollment of 718 CKD-HD patients in the US and Canada. Both studies allowed patients to continue to receive Triferic in the open-label extension study for up to one additional year.

Consistent with expectations, a preliminary review of the safety data revealed: Triferic reliably delivers iron via dialysate; there were no specific adverse events directly attributable to Triferic; the adverse events during Triferic administration were those common in CKD-HD patients; no difference in type, frequency, severity or resolution of adverse events between Triferic and placebo; no anaphylaxis or hypersensitivity attributable to Triferic; no evidence of changes in hepatic enzymes between Triferic and placebo; no evidence of first use events or an increase in intradialytic hypotension.

Triferic is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron that is lost during every dialysis treatment. Triferic is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic, which is subsequently mixed into dialysate. Once in the dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose.