Clinical: High-Risk Cardiovascular & Diabetes
Apabetalone, our lead select BET inhibition small molecule, is the first epigenetic drug to be tested in humans for the reduction of major adverse cardiac events (MACE) in high-risk cardiovascular disease (CVD) patients with type 2 diabetes mellitus and low high-density lipoprotein (HDL). Apabetalone treatment is targeted for the 30 million high-risk CVD and diabetes patients who are at most risk for major adverse events such as heart attack, stroke and sudden death. The Company is running a Phase 3 clinical trial, BETonMACE, which is enrolling high-risk diabetes patients with a primary endpoint of time to first occurrence of MACE.
Clinical: High-Risk Renal
Apabetalone is also being developed for expanded indications such as End Stage Renal Disease (ESRD) and Chronic Kidney Disease (CKD) Stages 3-4. The Phase 3 clinical program BETonMACE will test for renal function in a subset population of CKD patients measured by estimated glomerular filtration rate (eGFR). A Phase 2a program is also underway for ESRD patients which will examine safety and key risk biomarkers in this grievous disease.
Multiple proteomics assessments in high risk CVD patients have revealed links between markers connected with inflammation and other biological pathways and cognition. Moreover, both diabetes and CVD have been associated with higher levels of dementia and neurocognitive problems. The Phase 3 BETonMACE program will analyze cognition scores in patients over the age of 70 with the Montreal Cognitive Assessment (MOCA) scoring system. The data will be analyzed for the potential expansion of BET inhibitors in to the treatment of neurodegenerative disorders.
As leaders in the field of epigenetics and BET inhibition, with more than 8 years of clinical experience with apabetalone, Resverlogix continues to discover and evaluate novel roles for BET inhibitors in a variety of indications. With first hand clinical knowledge of BETi effects on the plasma proteome of patients, Resverlogix is a world leader in the field of epigenetic modulation. Our focus and passion is to build effective and mutually beneficial collaborations with partners that deliver breakthrough medicines to improve the outcomes for our patients. We continue to evaluate and offer opportunities for collaboration in the fields of muscular dystrophy, pulmonary arterial hypertension, neurofibromatosis and other orphan diseases.
In April 2015, Resverlogix and Shenzhen Hepalink Pharmaceutical Co., Ltd., a leading global life science company, entered into one of the largest strategic partnerships for a single molecule for high-risk cardiovascular disease patients including those with diabetes and CKD. A definitive agreement was completed in July 2015 where Resverlogix is eligible to receive sales-based milestone payments from Hepalink, each ranging from US$5 million to US$90 million and Royalties based on net sales. In addition, Hepalink will pay Resverlogix a royalty based on net sales. Total sales based milestones and royalty payments have an estimated potential in excess of USD$400 million.
In October 2017, Resverlogix entered into a Right of First Refusal Agreement with Hepalink USA Inc. Under the Agreement, Hepalink USA was granted a right of first refusal in connection with the licensing of the right to develop, manufacture and commercialize pharmaceutical products containing apabetalone in the United States until April 15, 2019. Hepalink USA paid $8 million to Resverlogix in consideration for the right of first refusal granted.
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