Surface Logix has commenced a company-sponsored Phase I clinical trial for SLx-2101, a novel, selective, oral PDE -5 inhibitor being evaluated for the treatment of cardiovascular diseases, including endothelial dysfunction and erectile dysfunction.
The Phase I study is a single centre, randomized, double-blind study designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of orally administered SLx-2101 in healthy male subjects.
“This study will assess the safety and tolerability of SLx-2101 and will provide significant information on the potency and duration of action of SLx-2101 across a range of doses. We also hope to establish a preliminary indication of efficacy in established models of endothelial function. Both peripheral arterial tone and erectile function are being evaluated utilizing two non-invasive methods of assessing endothelial function in healthy humans in this study,” notes Dr. William Prince, chief development officer. “Although the Phase I study has just started, the first PK results look quite promising. Even at a dose of 5mg, we can detect a substantial amount of drug in the blood past 36 hours,” adds Dr. Prince.
Dr. Paul Sweetnam, CSO notes, “As demonstrated in numerous preclinical animal models, SLx-2101 is a highly potent and selective compound with rapid cellular and tissue response and an extended duration of action. Our chemistry-based Pharmacomer technology platform permits us to access untapped chemistry space and to bring new functionality to medicinal chemistry. It has allowed us to develop a PDE -5 inhibitor program quite rapidly, from conception to first molecule into the clinic in less than two years.”
SLx-2101 is an oral phosphodiesterase-5 (PDE-5) inhibitor designed using Surface Logix’ proprietary small molecule Pharmacomer Technology.