Resverlogix said it will move ahead with its Phase 2a kidney dialysis trial following a Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA). The trial, to take place this year, will assess whether a combination treatment with apabetalone and standard of care (SoC) in patients receiving hemodialysis decreases alkaline phosphatase (an enzyme related to kidney damage) when compared a placebo and SoC combination.
This update, announced in a press release, follows the Type B meeting with, and Resverlogix’ receipt of the meeting’s minutes. Type B meetings are routinely held at predefined endpoints between the FDA and a sponsor — in this case, Resverlogix. Meetings typically take place right after or before the submission of clinical data or a new drug filing.
In keeping with FDA guidance, the Phase 2a study design will have two distinct parts. In part A, researchers will evaluate the drug properties (pharmacokinetics) of single-dose of apabetalone in eight patients receiving hemodialysis.
The results from Part A will be used to select the appropriate doses for Part B — a double-blind, randomized and placebo-controlled study with apabetalone. Part B will assess the safety and biomarker changes with apabetalone compared to placebo in up to 30 patients with end-stage renal disease treated with hemodialysis.
Resverlogix, headquartered in the Canadian city of Calgary, said it plans to submit an Investigational New Drug (IND) application to the FDA.
Apabetalone belongs to a group of compounds called BET bromodomain inhibitors that bind to a specific region of the BET proteins. It specifically inhibits the BRD4 protein, activating a cascade of events that regulate disease-causing genes and potentially benefit patients with diabetes mellitus, chronic kidney disease, Alzheimer’s disease and other illnesses.
Resverlogix recently reported positive results from a Phase 1 study of patients with severe kidney disease. The data showed that treatment with apabetalone reduced inflamed protein biomarkers in patients with severe kidney impairment versus healthy control patients.
Apabetalone is also being evaluated in a Phase 3 study (NCT02586155) with patients at high risk of cardiovascular disease with Type 2 diabetes and coronary artery disease.