Confirms BETonMACE database lock; reaffirms September 30, 2019 topline data availability
CALGARY, Alberta, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (RVX.TO) announced today the Late Breaking Science submission, regarding the primary results of the BETonMACE trial, has been accepted by the American Heart Association (“AHA”) for presentation during Scientific Sessions 2019 held in Philadelphia, Pennsylvania. The trial results will be presented at approximately 11:42 am ET on November 16, 2019; additional details can be found HERE.
At this time, the Company, its clinical steering committee, all investigators and the AHA remain blinded to the trial data.
In addition, Resverlogix confirms that, following the Company’s September 16th news release, BETonMACE achieved database lock on September 19, 2019. As a result, the Company reaffirms the expectation that topline data will be announced on or about September 30, 2019.
On April 18, 2019, BETonMACE successfully reached 250 projected MACE events, strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke. Final follow-up patient safety visits were reported by the Company on July 8, 2019 and database lock was achieved on September 19, 2019, marking important steps towards trial 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 only about 30% of cardiovascular disease related events leaving a significant market opportunity for apabetalone to address unmet medical need.
The BETonMACE trial is addressing 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 (RVX.TO).
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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 timing of BETonMACE topline readout, the presentation of BETonMACE data via future conferences including the AHA 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.