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 impacting global morbidity and mortality of the leading causes of deaths, such as cardiovascular diseases and diabetes.
About Hb1Ac and Diabetes
The HbA1c test is used to evaluate glucose control. Testing HbA1c is recognized as a standard of care for monitoring diabetes, specifically type II diabetes (T2DM). The American Diabetes Association recommends testing HbA1c for diagnosing diabetes as an alternative to fasting plasma glucose. Nondiabetics usually fall within the 4.0% – 5.6% HbA1c range, prediabetics usually have HbA1c levels of 5.7% – 6.4%, while those with 6.5% or higher HbA1c levels have clinical diagnosed diabetes. T2DM is characterized by chronic elevated blood glucose levels resulting from imbalanced hepatic glucose production and insulin secretion. Normalization of plasma glucose, as measured by HbA1c, in T2DM patients is known to be the target to improve insulin action, and to prevent the development of diabetic complications, including cardiovascular disease.
Current Anti-Diabetic Treatments
SGLT2 inhibitors represent the latest generation of oral anti-diabetic therapies and look to benefit patients with T2DM by reducing blood glucose levels, as measured by HbA1c. The American Diabetes Association states that the glycemic target for adults with T2DM is an HbA1c level that is less than 7.0% and as such the SGLT2 inhibitors are indicated for patients with uncontrolled HbA1c levels greater than 7.0%. First approved by the US FDA in 2013, these breakthrough therapies have demonstrated significant improvements in both renal and cardiovascular outcomes among T2DM patients. The market penetration of these treatments is expected to grow significantly over the next five years, with the potential global market value of approximately US$25 billion by 2024 (Mordor Intelligence 2019). However, no diabetes medication alone (including SGLT2 inhibitors) has been shown to reduce MACE in patients with recent ACS and substantial residual risk remains for this population.
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.
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 related to the strengthening of the Company’s IP portfolio, apabetalone’s commercial pathway position and strategic partnership discussions as a result of the filing of new provisional patent applications, plans to submit new data to a peer review journal and the potential role of apabetalone in the treatment of 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. 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.