Resverlogix announced the design of a Phase IIa kidney dialysis study, after in-person meetings with the FDA. The study will evaluate the addition of apabetalone to the standard of care, in comparison to placebo, and its effect on decreasing alkaline phosphatase.
Following FDA guidance, the study design will be separated in two parts, the company said. The first stage will involve a single-dose pharmacokinetic study in eight patients receiving hemodialysis, which will influence the subsequent dose selection stage.
The second part of the trial will be a double-blind, placebo-controlled, sequential cross-over study with apabetalone, and is designed to evaluate biomarker changes and safety parameters with apabetalone in up to 30 patients with end-stage renal disease treated with hemodialysis. Resverlogix intends to file an IND application and proceed with the trial this year.