MUNICH and CALGARY- Resverlogix Corp. (TSX: RVX) today announced that the BET protein inhibitor RVX-208 significantly increased HDL-C (p=0.001), the primary endpoint of the SUSTAIN trial, a phase 2b clinical study. SUSTAIN also successfully met secondary endpoints, showed increases in levels of Apo-AI (p=0.002) and large HDL particles (p=0.02), both believed to be important factors in enhancing reverse cholesterol transport activity. The SUSTAIN trial also showed that increases in alanine aminotransferase (ALT) reported in previous trials were infrequent and transient with no new increases observed beyond week 12 of the 24-week trial.
The SUSTAIN trial was directed by a clinical steering committee chaired by Dr. Steven Nissen with Dr. Stephen Nicholls serving as Principal Investigator. The committee has approved release of topline findings pending submission of full trial results for publication in a peer-reviewed medical journal.
"Successful completion of the SUSTAIN trial provides Resverlogix with important data regarding improvement in the functionality of the HDL produced by RVX-208," stated Donald McCaffrey, president and chief executive officer of Resverlogix. "Safety data from SUSTAIN reconfirm our belief that early liver signals witnessed in this and previous trials were of a transient nature," Mr. McCaffrey added. "The data support that RVX-208 is suitable for chronic use. The value of this knowledge will benefit our entire epigenetic and bromodomain research program by showing safe versions of epigenetic regulating molecules are indeed achievable. We believe that based on the collective knowledge gained from our recent trials, our company is well positioned as we approach the key plaque regression data expected in our ongoing ASSURE trial."
The phase 2b SUSTAIN trial was conducted in South Africa and led by investigators at the Cleveland Clinic. The study enrolled 176 patients with established atherosclerotic cardiovascular disease (CVD) and low high-density cholesterol (HDL-C). The primary purpose of the SUSTAIN trial was to measure changes in HDL, Apo-AI and other lipid parameters compared with placebo, while also assessing safety over an extended treatment period in the patient population with the largest response to RVX-208 in the phase 2 ASSERT trial. The increase in HDL and Apo-AI observed in the 24-week SUSTAIN trial represents a notable increase over the respective HDL and Apo-AI values reported in the 12-week ASSERT trial.
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