CALGARY, AB – Resverlogix Corp. says it has received the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA) for its proposed Phase 2A kidney dialysis trial.
The purpose of the meeting was to request written comments, recommendations and feedback on the trial. The primary objective of the study will be to evaluate if treatment with apabetalone in combination with standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC.
In light of the guidance received from the FDA, the company says the Phase 2a study design will be separated in two parts. Part A will involve a single-dose pharmacokinetic (PK) study in eight patients receiving hemodialysis. The PK results from Part A will influence the dose selection for Part B. Part B will be a double-blind, randomized, 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 official Investigative New Drug (IND) application and proceed with the planned Phase 2a clinical trial in 2017.