Vifor Pharma announced that its hypertension and chronic kidney disease (CKD) drug Veltassa (patiromer) has met its primary endpoint in phase II Amber study.
The study has showed a significantly higher proportion of patients with resistant hypertension (RHTN) and CKD taking Veltassa remained on spironolactone therapy compared against patients taking placebo at week 12.
Veltassa was demonstrated to allow persistent use of spironolactone by controlling blood potassium levels.
According to the company, the safety results are consistent with existing Veltassa data, with no new safety issues identified.
Veltassa is a sodium-free potassium binder secured approval for the treatment of hyperkalaemia. Veltassa, which is available in powder form that includes smooth and spherical beads, is mixed with water and taken once a day with food.
Indiana University School of Medicine professor Rajiv Agarwal said: “Despite the efficacy of spironolactone in patients with RHTN, its use has never been studied in those who also have CKD due to the occurrence or risk of developing hyperkalaemia.
“The AMBER data suggest that patients treated with patiromer may be more likely to stay on spironolactone therapy, a life-saving medicine for those with RHTN.”
Amber is a randomized, double-blind, placebo-controlled, parallel group study of patiromer for the enablement of spironolactone use for blood pressure control in patients with RHTN and CKD.
Spironolactone, which is a renin-angiotensin aldosterone system inhibitor (RAASi), is a major component in the recommended treatment guidelines for patients with resistant hypertension.
The company enrolled around 290 patients in the study at 60 sites in the US, South Africa, the UK, France, Germany, Croatia, Hungary, Georgia, and Ukraine.
The percentage of subjects remaining on spironolactone at week 12 compared between treatment groups is the primary end point of the study.
Vifor Pharma chief medical officer Thierry Teil said: “We are pleased with the AMBER study results and hope these data will support better adherence to guideline-directed treatment for patients with resistant hypertension and chronic kidney disease.
“We look forward to partnering with the community to further validate and explore the promise of Veltassa in fulfilling a clear unmet need among a complex patient population.”