Ardelyx Inc. (NASDAQ: ARDX) shares jumped on Tuesday after the firm announced positive results from its late-stage study in dialysis patients who have uncontrolled hyperphosphatemia. Specifically, this was the Phase 3 Amplify study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone.
Overall, the Amplify study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone.
For the primary endpoint, patients treated in the tenapanor arm had a statistically significant mean reduction in serum phosphorus from baseline to the end of the four-week treatment period, as compared to those treated in the binder arm.
During the treatment period, up to 49.1% of patients in the tenapanor arm achieved a statistically significant level of serum phosphorus, compared with up to 23.5% in the binder arm.
With additional positive results from that trial, Ardelyx will complete its New Drug Application (NDA) for tenapanor encompassing two indications: monotherapy and combination therapy for the treatment of hyperphosphatemia. The promising results from Amplify bring the firm one step closer to providing this important medicine to patients with CKD on dialysis.
Mike Raab, president and CEO, commented:
We are thrilled with the positive results from the Amplify study demonstrating that tenapanor can help significantly more patients achieve the established serum phosphorus treatment goal of less than 5.5 mg/dL. This result is striking as serum phosphorus levels above 5.5 mg/dL are associated with increased mortality. For too long, hyperphosphatemia management has been an enormous challenge for patients and clinicians. With tenapanor, patients may finally be able to achieve their treatment goal. We look forward to reporting results from our second Phase 3 monotherapy study, Phreedom, in the fourth quarter of this year.
Shares of Ardelyx were up about 26% on Tuesday to $4.28, in a 52-week range of $1.60 to $4.63. The consensus price target is $10.75.
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