interim results show efficacy of ZS 9 (sodium zirconium cyclosilicate) in hyperkalemia- ZS Pharma

ZS Pharma has presented interim results from ZS005, a long-term safety and efficacy study of ZS 9 (sodium zirconium cyclosilicate), an investigational treatment for hyperkalaemia. Results show that in patients with hyperkalaemia, ZS 9 rapidly normalised serum potassium levels and maintained serum potassium levels at 4.6 mEq/L with once daily treatment for up to 52 weeks, with more than 90% of patients maintained with 5 or 10 grams of ZS 9. In addition, improvement in metabolic acidosis was observed and consistent with previous studies and exposure corrected oedema rates were consistent with HARMONIZE placebo group and do not increase with duration of ZS 9 therapy. Rates of oedema and hypertension were consistent with the patient population over this time frame and there was a low rate (less than 5%) of gastrointestinal adverse events with ZS 9 treatment. Data were presented at the American Society of Nephrology's Kidney Week 2015.

Comment: AstraZeneca announced that it has entered into a definitive agreement to acquire ZS Pharma, giving AstraZeneca access to ZS 9. ZS 9 is under regulatory review by the FDA with a Prescription Drug User Fee Act goal date of 26 May 2016. A submission for European Marketing Application Authorisation is planned by the end of 2015. Current estimates for global peak year sales of ZS 9 exceed $1 billion.