World’s First Phase 3 BET Bromodomain Epigenetics Trial Reaches Events Target
CALGARY, Alberta, April 18, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announces that BETonMACE, the Company’s event-based, phase 3 registration trial has successfully reached 250 projected major adverse cardiac events (MACE), strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke, moving the trial towards completion. Successful data from this trial would enable Resverlogix to proceed towards the regulatory approval and commercialization of its lead drug, apabetalone.
“Resverlogix staff and stakeholders have worked diligently for the past 18 years to attain this extremely exciting goal,” said Donald McCaffrey, President and CEO of Resverlogix. “The trial’s extensive breakthrough clinical data will soon be available to Resverlogix. Successfully meeting the trial’s endpoints, the substantial data set and otherwise new findings would enable the Company to further solidify its apabetalone program as the world leader in epigenetic BET protein inhibition. Resverlogix is well positioned to advance therapies for several multi-factorial diseases with significant unmet need, and confirmation of our epigenetic technology would greatly change both the cost effectiveness and efficacy of future medications.”
The following steps are amongst those that will take place over the next 2 - 4 months to assure an orderly, safe and efficient culmination of BETonMACE:
- Last Study Visits (LSV) will commence immediately. All actively participating patients, still receiving the Investigational Product (IP) or statin, will be contacted to schedule visits to their particular site for a last visit or treatment visit. Those sites with the most patients enrolled will commence first, followed by the others. This will allow additional time to build the overall MACE events to about 260 or greater while not slowing down the trial’s move towards final database lock.
- Three to four weeks after the LSV, a post-IP follow-up visit will take place either in-person or via the phone to ensure that any safety issues continue to be monitored.
- In parallel with the procedures above, the third-party adjudication committee will continue to adjudicate remaining and ongoing potential MACE events. Current adjudicated events exceed 90% of the 250.
- All patients who have discontinued the study will also be contacted for an unscheduled follow-up visit or call to determine medical status.
- Database Lock (DBL) will occur after the last patient’s final visit and the last query is resolved.
- Approximately two weeks after DBL, the primary endpoint and additional secondary and exploratory endpoints are expected to be announced.
“We are nearing completion of this important, potentially transformative study,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development of Resverlogix. “At this time, we’d like to thank all study participants, the clinical sites and the many individuals who have supported the trial every step of the way. We look forward to completing the trial, and reporting the primary cardio/diabetes endpoint as well as other endpoints which include kidney and neurological function in the respective subsets of our patient group.”
Dosing with the Company’s lead compound – apabetalone – commenced in BETonMACE in November 2015 and the trial exceeded full enrollment – with a total of 2,425 study participants – in March 2018. BETonMACE has been reviewed nine times by the trial’s independent Data and Safety Monitoring Board, with no safety issues identified, and has been recommended to continue without any study modifications. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction of narrowly defined MACE for patients who remain on a high-dose statin therapy and top standard of care. Despite maximized use, current statin therapies manage about 30% of cardiovascular disease related events leaving a significant market opportunity for apabetalone. Following a successful BETonMACE trial, the company is focusing on three initial indications – acute coronary syndrome, vascular cognitive dementia and chronic kidney disease – with an addressable market of over 12 million patients in the top 8 markets.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
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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 successful completion and timing of the Company's Phase 3 clinical trial, regulatory approval and commercialization of apabetalone, and the potential role of apabetalone in the treatment of high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases. 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.