Calgary, Alberta (ots/PRNewswire) - The commencement of this Phase 1 pharmacokinentic (PK) trial in patients with severe renal impairment is the first in a series of planned clinical trials designed with value creation in mind.
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today 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/1.73m 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."
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is the first and only BET inhibitor selective for the second bromodomain (BD2) within the BET protein called BRD4. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with diseases such as high-risk cardiovascular disease (CVD), diabetes mellitus (DM), chronic kidney disease, Alzheimer's disease, Orphan diseases, and peripheral artery disease, while maintaining a well described safety profile. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials, currently in a Phase 3 trial BETonMACE in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL).
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
For further information please visit http://www.resverlogix.com.
Follow us on Twitter: @Resverlogix_RVX (https://twitter.com/resverlogix_rvx) (https://twitter.com/resverlogix_rvx), or on our blog at http://www.resverlogix.com/blog
This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company's Phase 3 clinical trial and the potential role of apabetalone in the treatment of CVD, DM, chronic kidney disease, Alzheimer's disease, Orphan diseases, and peripheral artery disease. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at http://www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.