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Top-Line Data Expected September 2019 for BETonMACE Phase 3 Cardiovascular Outcomes Trial for Apabetalone
Message: Resverlogix Provides Update on BETonMACE Phase 3 Epigenetics Trial
Last Treatment Visits Completed; Follow-up Safety Visits Progressing
CALGARY, Alberta, June 12, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) is pleased to announce today that all patients active in BETonMACE, the Company’s event-based, phase 3 registration trial, recently completed their last study visits on treatment. Final, follow-up safety visits are progressing and are expected to be completed by July 4th, 2019. Once safety visits have concluded for all patients, Resverlogix anticipates being in a position to provide an updated projected timeframe for top-line data readout.
The remaining steps are amongst those required to assure an orderly, safe and efficient culmination of BETonMACE:
- Three to four weeks after the last study visit for each patient, a follow-up safety visit will take place either in-person or via phone call to ensure that any safety issues continue to be monitored
- In parallel, the third-party adjudication committee will continue to adjudicate remaining and ongoing potential MACE events
- Additional MACE (over 250) that accumulate during this period will be added to the results while not slowing down the trial’s move towards final database lock
- All patients who have discontinued the study will be contacted for an unscheduled follow-up visit or call to determine medical status
- Database Lock (DBL) will occur sometime 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
- Late-2019 and beyond – full outcomes, pre-specified endpoint data, safety results, and clinical implications are expected to be reported and published
On April 18, 2019, BETonMACE successfully reached 250 projected major adverse cardiac events (MACE), strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke, moving the potentially landmark trial towards completion. Successful data from this trial would enable Resverlogix to proceed towards the regulatory approval and commercialization of its lead drug, apabetalone – a leader in a new class of drugs outside of oncology designed to regulate disease-associated proteins.
Dosing with apabetalone commenced 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, timing expectations for BETonMACE top-line readout 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.
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