Further Analysis of the ASSURE Data Finds a Responder Group for RVX-208 with Statistically Significant Regression of Coronary Atherosclerosis
"In patients with low HDL receiving RVX-208 and Rosuvastatin (Crestor®), plaque regression was twice as pronounced as compared to the pre-specified primary endpoint."
TSX Exchange Symbol: RVX
CALGARY, Sept. 3, 2013 /PRNewswire/ - Resverlogix Corp. (TSX:RVX) today announced the Full Analysis Set (FAS) data from 281 treated patients in its Phase 2b ASSURE clinical trial evaluating RVX-208 using intravascular ultrasound (IVUS) in high-risk cardiovascular patients. Current findings show that the below median HDL (<39 mg/dL) baseline population consisted of 92 patients who were taking either Rosuvastatin (Crestor®) or Atorvastatin (Lipitor®) together with RVX-208. Those patients taking Rosuvastatin and RVX-208 had a highly statistically significant Percent Atheroma Volume (PAV) plaque regression of -1.43% with probability value of p<0.002. This PAV regression exceeded the trial's pre-specified PAV endpoint (-0.6%) by more than two-fold. But those patients taking Atorvastatin (Lipitor®) together with RVX-208 had a PAV plaque progression of +0.19% with a non-significant probability value. The synergistic effect of the Rosuvastatin and RVX-208 combination is the basis for two recent provisional patent applications by Resverlogix.
Ongoing analysis is providing important insights into why the ASSURE topline results, reported previously on June 27, 2013, did not meet its primary endpoint of PAV change of -0.6%. Third party analysis of the ASSURE data showed that Rosuvastatin enhanced the actions of RVX-208 leading to synergistic treatment effects on PAV.
The responder population (i.e. HDL <39 mg/dL taking Rosuvastatin and RVX-208) exceeded the primary endpoint and also surpassed secondary endpoints reflecting regression in coronary atherosclerosis. These measures included total atheroma volume (TAV) and changes in the 10 mm most diseased segment of the coronary arteries, we noted marked regression versus baseline of -12.3 mm3 ( p< 0.0001) and -4.3 mm3 (p<0.0001), respectively. Other secondary endpoints assessed in this population were biomarkers of reverse cholesterol transport (RCT), including: HDLc, ApoA-I and large HDL particles which increased by 18.2% (p<0.0001), 16.4% (p<0.0001) and 74.7% (p<0.0001), respectively, vs. baseline.
"Clearly we have good reason to be very excited given the positive findings of a synergistic effect between Rosuvastatin and RVX-208 on coronary atherosclerosis. We were excited to observe that the RVX-208 responsive group did not differ from the originally intended population, namely those with low HDL receiving standard of care therapy. Our findings identify a statin that is superior when combined with RVX-208. These findings support two filed patent applications, thus potentially enabling patent protection until the year 2033 or beyond," said Donald McCaffrey, president and chief executive officer of Resverlogix.
Dr. Jan Johansson, senior vice president of medical affairs of Resverlogix added, "Plaque composition data recently reported at the European Society of Cardiology, showed significant plaque stabilization by RVX-208. In support of this finding, we noted an important trend in the ASSURE trial in that RVX-208 appeared to reduce major adverse cardiac events (MACE) including death from myocardial infarction (MI), MI without death, and revascularization. When events in ASSURE and the previously completed 24 week SUSTAIN trial were combined the MACE numbers were 46% less in the RVX-208 treated vs. the placebo population (p=0.09). But neither trial was designed or powered for MACE. Furthermore, the safety component of both trials again illustrated that the rare RVX-208 induced rise in the ALT was benign and manageable, i.e.) short in duration and appearing prior to week 12 of dosing. These findings are valuable for the development of RVX-208, the first BET-protein inhibitor to be tested in human clinical trials for cardiovascular disease."
Resverlogix will host a conference call and webcast with Q&A today, September 3rd at 11 am MDT.
Details for the conference call and webcast are as follows:
Link to webcast: http://services.choruscall.ca/links/resverlogix130905.html
Dial in numbers:
Canada & USA Toll Free Dial In: 1-800-319-4610
Outside of Canada & USA call: +1-604-638-5340
RVX-208 is a first-in-class small molecule that inhibits BET bromodomains. RVX-208 functions by removing atherosclerotic plaque via reverse cholesterol transport (RCT), the natural process through which atherosclerotic plaque is transported out of the arteries and removed from the body by the liver. RVX-208 increases production of Apolipoprotein A-I (ApoA-I), the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT. These newly produced, functional HDL particles are flat and empty and can efficiently remove plaque and stabilize or reverse atherosclerotic disease. ApoA-I may also exert beneficial effects in Diabetes Mellitus and Alzheimer's disease.
Resverlogix Corp. (TSX:RVX) is a clinical stage biotechnology company developing compounds involving ApoA-I production. RVX-208 is a first-in-class small molecule in development for the treatment of diseases such as atherosclerosis, Diabetes Mellitus and Alzheimer's disease. RVX-208 is the first BET bromodomain inhibitor in clinical trials. Resverlogix's common shares trade on the Toronto Stock Exchange (TSX: RVX). For further information please visit www.resverlogix.com. We can be followed 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 research and development activities and the potential role of RVX-208 in the treatment of diseases such as atherosclerosis, Diabetes Mellitus and Alzheimer's 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 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.
Donald J. McCaffrey
President and CEO
SVP Business & Corporate Development
SOURCE Resverlogix Corp.