Resverlogix Officially Attains Phase 3 Status with a European Regulatory Authority

CALGARY, Resverlogix Corp. today announced that following recent meetings with various European regulatory bodies, the first confirmation for our Phase 3 clinical plan has officially been received. A further regulatory and protocol design update will be provided to the market post the approval of additional regulatory bodies and the launch of our planned Phase 3 clinical trial entitled BETonMACE.

"This represents a momentous step forward in the clinical development of RVX-208," stated Donald McCaffrey, president and chief executive officer of Resverlogix.  "With this important regulatory confirmation now complete, we expect to launch the upcoming BETonMACE Phase 3 clinical trial this fall. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction (RRR) of Major Adverse Cardiac Events (MACE) in high-risk cardiovascular and diabetes mellitus (DM) patients, as we have seen in previous Phase 2 clinical trials with RVX-208," further stated Mr. McCaffrey.

About RVX-208

RVX-208 is a first-in-class, small molecule selective BET bromodomain inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can turn disease-causing genes off, returning them to a healthier state. RVX-208 is the first and only BET inhibitor selective for BRD4-BD2, producing a nexus of biological effects with potentially important benefits for patients with diseases such as cardiovascular disease (CVD), diabetes mellitus (DM), Alzheimer's disease, peripheral artery disease, and chronic kidney disease while maintaining an excellent safety profile. Resverlogix is planning to study RVX-208 in a proposed Phase 3 clinical trial in CVD patients with DM and low HDL.

Source: Resverlogix Corp.