Brief: Resverlogix says proposed Phase 2A kidney dialysis study design to be separated in two parts

Resverlogix

23/02/2017 12:00

Feb 23 (Reuters) - Resverlogix Corp  RVX.TO : 
    * Resverlogix - study to evaluate if treatment with 
apabetalone with standard of care decreases alkaline phosphatase 
in comparison to placebo and soc 
    * Resverlogix reports positive FDA type B meeting on design 
issues relating to a proposed phase 2A kidney dialysis trial 
    * Resverlogix Corp - in light of guidance received from FDA, 
phase 2A study design will be separated in two parts 
    * Resverlogix Corp - part a of study will involve a 
single-dose pharmacokinetic (PK) study in eight patients 
receiving hemodialysis 
    * Resverlogix Corp - PK results from part a will influence 
dose selection for part B study 
    * Resverlogix Corp - part B study will be a double-blind, 
randomized, placebo-controlled, sequential cross-over study with 
apabetalone 
    * Resverlogix Corp - intends to file an official 
investigative new drug (IND) application and proceed with 
planned phase 2A clinical trial in 2017 
 
Source text for Eikon:  ID:nCNWLcGy9a  
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