Dr. Michael Sweeney reports
RESVERLOGIX ANNOUNCES FOURTH POSITIVE RECOMMENDATION FROM DATA SAFETY MONITORING BOARD FOR PHASE 3 STUDY OF APABETALONE
The independent data and safety monitoring board (DSMB) for Resverlogix Corp.’s phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a fourth planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified, and will conduct additional periodic reviews. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.
“The BETonMACE Phase 3 trial now has approximately 1,600 patients enrolled, representing approximately 67 percent of total planned enrollment. Since the trial commenced in November, 2015, we now have patients that have been on treatment with apabetalone for over 76 weeks, more than three times longer than any treatment duration in any of the Company’s previous Phase 2 trials. This recommendation confirms that apabetalone continues to be safe and well-tolerated and with the addition of clinics in Taiwan and Russia, we remain on track for full enrollment by the fall of 2017″ stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is the first and only BET inhibitor selective for the second bromodomain (BD2) within the BET protein called BRD4. 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 (CVD), diabetes mellitus (DM), 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. Apabetalone is the only selective BET bromodomain inhibitor in human clinical trials. Apabetalone is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2 DM and low high-density lipoprotein (HDL), and is expected to be initiated in a Phase 2a kidney dialysis trial designed to evaluate biomarker changes and safety parameters in up to 30 patients with end-stage renal disease treated with hemodialysis.
We seek Safe Harbor.