Announces publication of accompanying JAMA editorial highlighting important secondary endpoints including congestive heart failure
Apabetalone development program moving toward next study to enable a New Drug Application filing
CALGARY, Alberta, March 30, 2020 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the recent publication of an article titled: “Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes,” in the high-impact, peer-reviewed Journal of the American Medical Association (JAMA).
The publication can be viewed using the following LINK.
“The results published in JAMA bode well for the future development of apabetalone,” said Professor Kausik Ray, Professor of Public Heath, Imperial College London, and the lead author of the study. “We have learned a great deal from the data generated in BETonMACE, which is being applied to the design of Resverlogix’s next study to address an unmet need in a high-risk patient population.”
As commented by Dr. Jorge Plutzky, MD, Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, in a JAMA Editorial published March, 27, 2020, titled: “Epigenetic Therapeutics for Cardiovascular Disease Writing, Erasing, Reading, and Maybe Forgetting,” Dr. Plutzky stated, “Exploratory analysis of secondary end points […] suggested that apabetalone was associated with a reduced risk of first (29 vs 48, P=.03) or first and recurrent congestive heart failure (CHF) hospitalizations (35 vs 70).” Dr. Plutzky further commented that ‘the possible effects of apabetalone on heart failure outcomes suggests an expanded CHF end point might have reached significance’. The full online editorial can be accessed HERE.
“We are very encouraged by the results presented in JAMA and the accompanying editorial – which is based on the large Phase 3 trial, BETonMACE – the first ever testing a BET inhibitor for a cardiovascular disease indication,” said Dr. Michael Sweeney, Senior Vice President, Clinical Development of Resverlogix. “The addition of apabetalone to standard of care therapy in the trial’s high-risk patient population showed a strong trend towards a reduction in major adverse cardiac events (MACE) and hospitalization for heart failure. Apabetalone’s strong safety profile, along with the latest published results, allows us to move this novel therapy into a subsequent study under US FDA granted Breakthrough Therapy Designation to enable a New Drug Application filing.”
JAMA Publication Highlights include:
- Apabetalone recently completed the first ever Phase 3 clinical trial of a BET inhibitor for a cardiovascular disease indication
- Although not reaching significance in its primary outcome measure, apabetalone treatment provided a promising trend towards reduction in MACE (10.3% in apabetalone-treated and 12.4% in placebo-treated patients, hazard ratio 0.82, 95% CI 0.65-1.04), among type 2 diabetic patients with acute coronary syndrome (ACS) and low HDL cholesterol
- Clinically significant reduction in the risk of hospitalization due to CHF was observed
- Clinically significant reductions in the primary endpoint were observed in pre-specified subgroups of the trial population, including those with a baseline estimated glomerular flow rate (eGFR) of less than 60 mL/min/1.73 m2
- Apabetalone continued its long proven safety record in this trial, with the treatment group reporting similar rates of adverse events to the placebo group
Publication Background and Conclusions:
Apabetalone is an inhibitor of BET proteins, which has been shown in a number of applications to target markers and pathways associated with cardiovascular disease progression. In previous clinical trials, apabetalone reduced the incidence of major adverse cardiac events (MACE) by up to 62% in various cardiovascular disease patient populations. Although treatment did not produce a statistically significant hazard reduction in the primary outcome measure, there was a strong trending hazard reduction – comparable with that of other cardiovascular outcome trials that led to approvals – and the authors of the publication and editorial suggest a larger trial with expanded endpoints may yield a different result.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. Apabetalone is the first therapy of its kind to have been granted US FDA Breakthrough Therapy Designation – for a major cardiovascular indication – to help facilitate a time-efficient drug development program including planned clinical trials and plans for expediting the manufacturing development strategy.
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.
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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 related to data from Phase 3 Clinical Trial BETonMACE, further supporting the potential and on-going development of apabetalone, the potential of a larger subsequent trial to BETonMACE with expanded endpoints that may yield different results and the potential role of apabetalone in the treatment of patients with cognitive disorders, high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, 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.