Dive Brief:
- Resverlogix, a Canadian biotech, said Feb. 23 it had met with the Food and Drug Administration about a Phase 2a kidney dialysis trial. It aims to evaluate whether treatment with its lead candidate apabetalone (RVX-208) and standard-of-care decreases alkaline phosphatase in comparison to placebo and standard-of-care.
- After getting FDA guidance at a Type B meeting, which Resverlogix described as "positive," the biotech said it will redesign its study, separating it into two parts.
- Resverlogix, which trades on the Toronto Stock Exchange, said it intends to file an official investigative new drug (IND) application and move ahead on the planned Phase 2a clinical trial in 2017.
Dive Insight:
Resverlogix said the purpose of the meeting, held with the FDA’s cardiovascular and renal products division, was to request written comments, recommendations and feedback on the proposed protocol for its Phase 2a kidney dialysis trial.
Under the redesign, Part A will be a single-dose pharmacokinetic (PK) study in eight patients on hemodialysis. The PK results from Part A will influence dose selection for Part B, a double-blind, randomized, placebo-controlled study aiming to evaluate biomarker changes and safety parameters with apabetalone in up to 30 patients with end-stage renal disease on hemodialysis.
This is the latest of multiple announcements in recent weeks about Resverlogix’s apabetalone, a small-molecule selective BET bromodomain inhibitor. The company says the BET inhibitor offers a strong safety profile and potentially important benefits for patients with illnesses including cardiovascular disease, diabetes, chronic kidney disease, orphan diseases, peripheral artery disease and Alzheimer's disease.
On Feb. 13, Resverlogix said third-party academic research had identified two potentially new indications for apabetalone: in degenerative diseases of the eye, and a rare condition called Facioscapulohumeral muscular dystrophy. The company described both indications as "areas of interest and licensing potential for Resverlogix."
On Jan. 23, the biotech reported preliminary results from a New Zealand-based Phase 1 trial with severe kidney-impaired patients that found several key proteins driving renal disease and dialysis risk were down regulated after a single dose of apabetalone.
In the fall of 2015, Reverlogix launched a Phase 3 clinical trial, BETonMACE to evaluate the use of apabetalone for high-risk cardiovascular disease patients with type 2 diabetes and low HDL. The primary endpoint is time to first occurrence of Major Adverse Cardiac Events (MACE).
Previously, the company had initiated nine Phase 1/2 clinical trials of apabetalone, completing the first in 2008.