Resverlogix Corp. has announced that it has received approval by the US Food and Drug Administration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in the USA. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL.
ApoA-I is regarded as the critical cardioprotective protein for the treatment of cardiovascular diseases.
The Phase I clinical trial is taking place at a leading US contract research organization. The trial consist of three arms, an ascending single dose, a fed and fasted dose effect study, and a 7-day ascending multiple dose that will enroll a total of 70-80 healthy volunteers. The primary objective of the trial is to evaluate oral RVX-208 in healthy adult subjects for safety, tolerability, and pharmacokinetics. Results from this Phase 1a trial will be used for optimizing dosing for future trials including our Phase 1b trial.
Gregory S. Wagner, PhD, Senior Vice President, Preclinical Development of Resverlogix, stated that, "RVX-208 possesses a very favorable pharmacological and pharmaceutical profile. This compound is an excellent choice to be the first drug candidate from our preclinical pipeline, our research and development team has worked aggressively to rapidly advance it into clinical development."
"This field has been developing for 50 years. In multiple human and animal studies over-expression or repeated infusion of ApoA-I inhibit progression and induce regression of atherosclerosis in both animals and humans," stated Dr. Jan Johansson, MD, PhD. Senior Vice President of Clinical Affairs of Resverlogix. "We have identified a way to increase the endogenous production of ApoA-I via a small molecule drug. The initiation of this clinical trial is a milestone for the field of ApoA-I research," confirmed Dr. Johansson.