We are dedicated to providing novel science, clinical and value-based health solutions to key stakeholders such as pharmaceutical, physician, and payer groups. We have taken our knowledge of epigenetics and, through the mechanism of selective BET inhibition, applied it to high-risk cardiovascular patients that are the leading cost drivers of health systems globally. One of our key tenets is to provide a complete solution to key pharmaceutical partners that will drive innovation, strong clinical efficacy and robust health value for reimbursement programs.
Shenzhen Hepalink Pharmaceutical Co., Ltd.
In April 2015, Resverlogix and Shenzhen Hepalink Pharmaceutical Co., Ltd. (“Hepalink”), a leading global life science company, entered into one of the largest ever strategic partnerships for a single molecule – apabetalone (RVX-208) – in high-risk cardiovascular disease patients, including those with diabetes and chronic kidney disease (“CKD”). A definitive agreement was completed in July 2015 where Resverlogix is eligible to receive sales-based milestone and royalty payments.
Medison Pharma Ltd.
On January 08, 2018, Resverlogix entered into a licensing agreement with Medison Pharma Ltd. (“Medison”) for apabetalone in Israel and the Palestine Authority. Under the terms of the agreement, Medison has the exclusive rights to distribute and market apabetalone in Israel. Medison will be responsible for all regulatory, sales and marketing costs for apabetalone in the Israel region.
We are currently focused on bringing apabetalone to market for three key indications: high risk cardiovascular disease & diabetes, chronic kidney disease, and neurodegeneration / dementia. We continue to pursue additional opportunities for collaboration in the fields of muscular dystrophy, pulmonary arterial hypertension, neurofibromatosis and other orphan diseases.
CLINICAL: High-risk Cardiovascular Disease & Diabetes
Apabetalone is the first epigenetic drug to be tested in humans for the reduction of major adverse cardiac events. We are currently running a Phase 3 clinical trial, BETonMACE, in high-risk cardiovascular disease patients with type 2 diabetes mellitus and low high-density lipoprotein, with a primary endpoint of time to first occurrence of Major Adverse Cardiac Events (MACE). Apabetalone treatment could significantly benefit the approximately 2 million high-risk CVD and diabetes patients in the top seven global markets. The patients who have had a recent acute coronary event, with correspondingly low HDL, are at most risk for major adverse events such as cardiac-related death, heart attack, stroke, and peripheral arterial disease.
CLINICAL: Chronic Kidney Disease
Apabetalone is also being evaluated for the treatment of patients with chronic kidney disease (CKD). Estimated glomerular filtration rate (eGFR) will be measured for BETonMACE patients, and a predefined subset of the patients with low baseline eGFR will be evaluated for improvements in renal function versus placebo. A Phase 2a program is also underway for CKD patients on dialysis, which will examine safety and key risk biomarkers.
CLINICAL: Vascular Cognitive Dementia
Both diabetes and CVD have been associated with higher levels of dementia and neurocognitive problems. Moreover, multiple proteomics assessments have revealed significant overlap between processes associated with CVD – vascular inflammation and calcification – and the biological pathways that drive cognitive risk. Our Phase 3 trial, BETonMACE, includes a pre-specified analysis of cognition scores in patients over the age of 70, utilizing the Montreal Cognitive Assessment (MoCA). Changes in MoCA scores for patients undergoing apabetalone treatment will be compared with the placebo arm of two separate groups: those with a baseline MoCA score of 26 or higher (normal cognitive function), and those with 25 and below (mild to moderate cognitive function). An improvement in MoCA scores with apabetalone treatment could signal its efficacy in the treatment of neurodegenerative disorders such as dementia and vascular cognitive impairment.