Spectrum Pharmaceuticals announced positive, statistically significant data from the company’s Phase 1 clinical trial evaluating the safety and tolerability of RenaZorb in healthy volunteers. RenaZorb is an orally available, lanthanum-based nanotechnology compound with potent phosphate-binding properties that is being developed for the potential treatment of hyperphosphatemia (high phosphate levels in the blood) in patients with stage 5 chronic kidney disease. The Phase 1 clinical findings showed that (1) RenaZorb is well-tolerated up to the maximum administered dose of 6000 mg/day, showing no serious adverse events, low systemic exposure, and no discontinuations of therapy, (2) RenaZorb resulted in statistically significant reductions in daily urinary phosphorous excretions at all four dose levels compared to placebo. The double-blind, dose-ranging, Phase 1 study in healthy volunteers was designed to evaluate the safety, PK and the phosphate-binding capacity of RenaZorb. The primary endpoint is safety and tolerability. Secondary endpoints are pharmacokinetics (measurements of serum lanthanum levels) and phosphate binding capacity (capacity to bind phosphorous ingested with food, evaluated by comparing the difference in urine and fecal phosphorus levels measured before and after RenaZorb dosing).
- Pharmaceuticals & Drug Trials
- Spectrum Pharmaceuticals