Just a week after ZS Pharma announced new data analysis concerning ZS-9 (sodium zirconium cyclosilicate) treatment efficacy for patients with hyperkalemia associated with heart failure, the company revealed positive results from their second phase 3 clinical trial, HARMONIZE (ZS004).
“With the completion of the HARMONIZE trial, we remain on track to submit NDA and MAA filings for ZS-9 in the first half of 2015,” stated Robert Alexander, PhD, Chief Executive Officer of ZS Pharma, in a news release from the company. “Importantly, our clinical experience with ZS-9 now includes nearly 1000 patients, some of whom have been treated with ZS-9 for over 5 months.”
Enrollment for ZS004 was completed in July, and treatment was conducted for 28 days. Three doses of ZS-9 were used in the study, and all three doses allowed patients to meet the primary endpoint of preventing hyperkalemia recurrence. The study was placebo-controlled and also identified the safety, tolerability, and adverse event rate of ZS-9 treatment.
Data as strong as this for ZS Pharma’s ZS-9 hyperkalemia therapy is likely to be presented at upcoming scientific meetings in order to inform the research and medical community of the ongoing success in developing the drug. Indeed, according to Dr. Alexander, “We are excited to announce these preliminary results and look forward to having the lead study investigator, Mikhail Kosiborod, MD, share the full data at a late-breaking session at the American Heart Association meeting.” The meeting will be conducted in November, and the presentation will be given during the late-breaking Clinical Science Special Reports Session.
Positive news of ZS-9 comes at a key time for ZS Pharma, as the company recently raised $107 million in a high-profile IPO, thus increasing interest and awareness around their R&D efforts to bring a viable hyperkalemia therapy to market.