Resverlogix Reports Filing of New Intellectual Property on Key Renal Protection and Glucose Control Markers

Significantly Strengthens Intellectual Property Portfolio and Apabetalone’s Commercial Runway Position Through 2040

BETonMACE Results Show Significant Improvement of Key Markers of Diabetes and Renal Function in the Combination of Apabetalone and SGLT2 inhibitors

CALGARY, Alberta, Nov. 02, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX) is pleased to announce today highly significant findings on synergy on improved renal function, as measured by estimated glomerular filtration rate (eGFR), and glucose control, as measured by glycated hemoglobin (HbA1c), when apabetalone is combined with sodium-glucose cotransporter-2 (SGLT2) inhibitors, a leading oral anti-diabetic therapy class. These unexpected findings in the BETonMACE Phase 3 trial resulted in the filing of two additional provisional patent applications, further strengthening Resverlogix’s intellectual property portfolio.

The combination of apabetalone and the SGLT2 inhibitors, in addition to standard of care medicines, resulted in a significant improvement of key renal function marker eGFR compared to SGLT2 inhibitors and placebo (p=0.05). Additionally, a significant reduction of plasma Hb1Ac was also observed in patients receiving the combination of apabetalone and the SGLT2 inhibitors, on top of standard of care treatment, compared to placebo (p<0.001). Details of these findings are planned to be submitted to a leading peer review journal in the near future.

“The robust safety and efficacy demonstrated by the combination of apabetalone and SGLT2 inhibitors greatly assists us in our strategic partnership discussions and significantly enhances our intellectual property portfolio and commercial runway position through 2040,” stated Donald McCaffrey, President and CEO. “These important findings – coupled with the significant MACE reduction effects previously highlighted for this patient group – positions the combination of apabetalone and SGLT2 inhibition as a truly novel approach in the treatment for millions of high-risk diabetes and CKD patients worldwide.”

“Plasma eGFR and Hb1Ac are critical markers used to evaluate renal function and glucose control in high-risk patients with kidney disease and diabetes,” stated Kenneth Lebioda, Senior Vice President of Business & Corporate Development. “Control of these markers play a key role in CVD risk reduction as observed in the BETonMACE study, including heart attack, heart failure and CVD death in these patients. These novel and unexpected findings are now patent protected and allow for Resverlogix to explore additional important indications for the combination of apabetalone and SGLT2 inhibitors with an accelerated path to commercialization.”

About eGFR and CKD

According to the National Kidney Foundation, renal function, as measured by eGFR is the strongest non-invasive way to assess renal function and the stage of chronic kidney disease (CKD) in patients. Using a patient’s blood creatinine level, age, body size and gender, physicians can determine the stage of CKD and the optimal treatment plan to improve the likelihood of reducing kidney disease and associated-disorders progression. In the Global Burden of Disease Study, CKD is estimated to affect nearly 700 million people worldwide, many of them still undiagnosed. CKD and worsening renal function impact several other high-risk patient disease groups, and serves as a comorbidity for diabetes, while also indirectly

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‘Modest’ Benefit for Post-MI Flash Glucose Monitoring in T2D

Following a heart attack, there appears to be a “modest” benefit of using flash glucose monitoring over fingerstick testing to monitor blood glucose levels in patients with type 2 diabetes being treated with insulin or a sulfonylurea, according to investigators of the LIBERATES trial.

The results showed a nonsignificant increase in the time that subjects’ blood glucose was spent in the target range of 3.9-10.00 mmol/L (70-180 mg/dL) 3 months after experiencing an acute coronary syndrome (ACS).
At best, flash monitoring using Abbott’s Freestyle Libre system was associated with an increase in time spent in range (TIR) of 17-28 or 48 minutes per day over self-monitoring of blood glucose (SMBG), depending on the type of statistical analysis used. There was no difference in glycated hemoglobin A1c levels between the two groups, but there was a trend for less time spent in hypoglycemia in the flash monitoring arm.

Viewers Underwhelmed

“My overall impression is that the effects were less pronounced than anticipated,” Kare Birkeland, MD, PhD, a specialist in internal medicine and endocrinology at Oslo University Hospital, Rikshospitalet, Norway, observed after the findings were presented at the virtual annual meeting of the European Association for the Study of Diabetes.

Others who had watched the live session seemed similarly underwhelmed by the findings, with one viewer questioning the value of devoting an hour-and-a-half session to the phase 2 trial.

However, the session chair Simon Heller, BA, MB, BChir, DM, professor of clinical diabetes at the University of Sheffield, and trial coinvestigator, defended the detailed look at the trial’s findings, noting that it was worthwhile to present the data from the trial as it “really helps explain why we do phase 2 and phase 3 trials.”

Strong Rationale for Monitoring Post-MI

There is a strong rationale for ensuring that blood glucose is well controlled in type 2 diabetes patients who have experienced a myocardial infarction, observed Robert Storey, BSc, BM, DM, professor of cardiology at the University of Sheffield. One way to do that potentially is through improved glucose monitoring.

“There’s clearly a close link between diabetes and the risk of MI: Both high and low HbA1c are associated with adverse outcome, and high and low glucose levels following MI are also associated with adverse outcome,” he observed, noting also that hypoglycemia was not given enough attention in post-ACS patients.

“The hypothesis of the LIBERATES study was that a modern glycemic monitoring strategy can optimize blood glucose levels in type 2 diabetes patients following MI with the potential to reduce mortality and morbidity and improve quality of life,” Storey said. “The main research question of LIBERATES says, ‘Do new approaches in glucose monitoring increase the time in range and reduce hypoglycemia?’ ”

Pragmatic Trial Design

LIBERATES was a prospective, multicenter, parallel group, randomized controlled trial, explained the study’s statistician Deborah Stocken, PhD, professor of clinical trials research at the University of Leeds. There was “limited ability to blind the interventions,” so it was an open-label design.

“The patient population in LIBERATES was kept

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