An anonymous director reports
RESVERLOGIX PROVIDES UPDATE ON BETONMACE PHASE 3 EPIGENETICS TRIAL
All patients active in
BETonMACE, Resverlogix Corp.'s event-based phase 3 registration trial, have completed their last study visits on treatment. Final follow-up safety visits are progressing and expected to be completed by July 4, 2019. Once safety visits have concluded for all patients, Resverlogix anticipates being in a position to provide an updated projected time frame 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 continuing potential major adverse cardiac events (MACE):
- Additional (over 250) MACE that accumulate during this period will be added to the results, while not slowing down the trial's move toward final database lock (DBL).
All patients who have discontinued the study will be contacted for an unscheduled follow-up visit or call to determine medical status.
- Database lock will occur some time after the last patient's final visit and the last query is resolved
Approximately two weeks after DBL, the primary end point as well as additional secondary and exploratory end points are expected to be announced.
Late 2019 and beyond -- full outcomes, prespecified end point 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, strictly defined as cardiovascular death, non-fatal myocardial infarction and stroke, moving the potentially landmark trial toward completion. Successful data from this trial would enable Resverlogix to proceed toward 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 enrolment -- 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 end point 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 per cent 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 eight markets.
About Resverlogix Corp.
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 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.
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