Resverlogix Corp has announced that dosing has commenced in a Phase 1 PK study with lead drug candidate apabetalone (RVX-208) in patients with severe renal impairment. While the Company's Phase 3 BETonMACE trial, designed for high-risk cardiovascular disease patients with type 2 diabetes and low HDL is enrolling as planned, this Phase 1 trial has been initiated and designed in accordance with the Company's strategy to expand into new indications such as renal (chronic kidney disease) and orphan diseases with our lead candidate, apabetalone.
This trial has the potential to create increased value for apabetalone in new high-risk patient segments which have shorter development paths to product registration and market adoption. The primary objective of the Phase 1 study, based in New Zealand, is to determine if apabetalone treated patients with severe renal impairment have the same favorable PK traits as has been witnessed in previous apabetalone trials. Results are expected in the second half of 2016, and if successful, will allow for more advanced renal impairment and dialysis trials to proceed.
The study will also explore acute changes in biomarkers relevant to Bromodomain and Extra-Terminal (BET) inhibition in subjects with severe renal impairment. Two cohorts, each comprised of eight subjects, will be evaluated in the study. Cohort one will include subjects with end-stage renal disease (ESRD) not on dialysis, with an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m2 while cohort two will include healthy individuals whose age, weight and gender will be matched to the renal impaired subjects. All subjects will receive a single oral administration of 100mg of apabetalone.
Dr. Kamyar Kalantar-Zadeh, Chairman of the Renal Clinical Advisory Board, and member of the BETonMACE Clinical Steering Committee stated, "The results from this study will further assist the Company in advancing planned Phase 2 trials into expanded renal indications. Additionally, potential effects on novel biomarkers and pathways affected by select BET inhibition in patients with severe renal impairment may be elucidated and provide insight for the pre-specified subgroup in Resverlogix's Phase 3 clinical trial BETonMACE, where is it anticipated that approximately 15 percent of subjects will have moderate renal impairment."