Keryx Biopharmaceuticals (NASDAQ:KERX) has announced positive results from its pivotal 24-week phase 3 study of Ferric Citrate that is will be used to treat iron deficiency anemia in adults who are in the 3-5 stage if non-dialysis dependent chronic kidney disease. The study achieved its primary endpoint all pre-specification of secondary endpoints with statistical significance.
Iron deficiency anemia (IDA) is a common complication of chronic kidney disease (CKD) and its prevalence and severity of IDA increases as the kidney disease progresses. Roughly, around 1.6 million people in the U.S. are in stage 3-5 non-dialysis dependent CKD and IDA. If the Ferric Citrate, which is an iron-based medication,is approved for the treatment of IDA in stage 3-5 NDD CKD patient, it will become the first FDA-approved iron treatment in a tablet form.
During the phase 3 study, Ferric citrate treatment was compared to placebo in 234 patients who had initially had not responded appropriately to or tolerated current oral iron therapies. The primary endpoint of the study was achieved with 52% of the patients who received Ferric Citrate recording a 1g/dL or higher rise in hemoglobin at any point during the whole 16-week randomized efficacy period. This figure was compared to placebo that only achieved 1%. Ferric Citrate result was considered clinically meaningful and statistically significant improvement.
Placebo group had two patient terminate the study and were not included in the efficacy results. One discontinued before being receiving a placebo while the other stopped after taking a dose of placebo but before lab values could be drawn. Statistically significant results were observed in the secondary efficacy endpoint. During the 24 weeks of the study, ferric citrate was well tolerated, and adverse effects were consistent with safety profile. Diarrhea was reported as the most common adverse event.
The phase three result showed that ferric citrate can effectively raise hemoglobin levels in stage 3-5 NDD CKD patient with effect being observed as early as two weeks post-treatment initiation, notes John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals.