Keryx Biopharmaceuticals (NASDAQ:KERX), a biopharmaceutical company focused on bringing innovative medicines to market for people with renal disease, today announced positive top-line results for its pivotal 24-week Phase 3 study of ferric citrate, an oral, iron-based medicine in development for the treatment of iron deficiency anemia (IDA) in adults with stage 3-5 non-dialysis dependent chronic kidney disease (NDD CKD). The study met its primary endpoint and all pre-specified secondary endpoints with statistical significance.
Iron deficiency anemia is a common complication of CKD, and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. If ferric citrate is approved for the treatment of iron deficiency anemia in stage 3 – 5 NDD CKD patients, it would be the only FDA-approved iron treatment in a tablet form available to these patients.
The Phase 3 study compared treatment with ferric citrate to placebo in 234 patients who previously had not adequately responded to or tolerated current oral iron therapies. The study achieved the primary endpoint with 52 percent (61/117) of patients who received ferric citrate achieving a 1g/dL or greater rise in hemoglobin at any time point during the 16-week randomized efficacy period, compared to 19 percent (22/115) in the placebo group (p<0.001), a clinically meaningful and statistically significant improvement. Two patients in the placebo group discontinued the study and were not included in the efficacy analysis – one discontinued after randomization prior to receiving placebo, one discontinued after taking a dose of placebo but before having laboratory values drawn. Statistically significant differences in all pre-specified secondary efficacy endpoints were also observed. During the full 24 weeks of the study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event.
“These Phase 3 results demonstrate that ferric citrate can effectively raise hemoglobin levels in stage 3 – 5 non-dialysis dependent chronic kidney disease patients, with effects observed as early as two weeks post-treatment initiation,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “Based on these results, we plan to submit an sNDA to the FDA in the third quarter, seeking to expand the label for ferric citrate to include the treatment of iron deficiency anemia in people with stage 3 – 5 NDD CKD. We believe that the ability to treat iron deficiency anemia, managing hemoglobin and iron levels, could have an important effect on the way kidney specialists treat these patients.” (Original Source)
Shares of Keryx are up nearly 32% in pre-market trading. KERX has a 1-year high of $13.10 and a 1-year low of $2.80. The stock’s 50-day moving average is $4.16 and its 200-day moving average is $4.35.
On the ratings front, Keryx has been the subject of a number of recent research reports. In a report issued on February 29, FBR analyst Christopher James upgraded KERX to Buy, with a price target of $10, which implies an upside of 119.8% from current levels. Separately, on February 26, J.P. Morgan’s Whitney Ijem downgraded the stock to Hold.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Whitney Ijem have a total average return of -21.6% and -10.3% respectively. James has a success rate of 20.7% and is ranked #3700 out of 3749 analysts, while Ijem has a success rate of 27.3% and is ranked #3166.
Keryx Biopharmaceuticals Inc is a biopharmaceutical company focused on therapies for patients with renal disease. Its first product is the AuryxiaTM (ferric citrate), an oral, absorbable iron-based compound.