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