The primary objectives of the Phase Ia trial were to examine the safety, tolerability and pharmacokinetics of RVX-208. This study successfully met those objectives. In addition to the completed Phase Ia human clinical trial, RVX-208 has been the subject of 126 preclinical studies to date, comprising safety, toxicity, pharmacokinetics and pharmacology studies. The company has also selected the dosages to be used in the 28-day Phase Ib/IIa study.
Donald McCaffrey, president and CEO of Resverlogix, said: “Initial results from the emerging data are very good. With these successful results in hand we are now planning for our Phase Ib/IIa trial which, pending discussions and approval from the FDA, we expect to start later this year.”