SURFACE LOGIX'S TRIAL ACHIEVES TARGET PROFILE
Surface Logix has announced the successful completion of the first clinical
trial for SLx-2101. The Phase I study was designed to assess the safety and
tolerability of SLx-2101, establish the pharmacokinetic profile, and to provide
evidence of activity in two pharmacodynamic models. The results of this study
will be presented at the upcoming Sexual Medicine Society of North America meeting
in New York City.
In a double-blind, randomized, placebo-controlled study, healthy male volunteers received single oral doses of SLx-2101 or placebo. Five dose levels were included and subjects were monitored for adverse events and pharmacokinetic sampling was performed up to 48 hours post-dose. Two methods of assessing pharmacodynamic activity were included in the study. Erectile response was assessed over 24 hours using the Rigiscan Plus system and peripheral arterial tone was assessed using the Endo-PAT2000 device.
The results from the trial confirm the ability of the Pharmacome Technology Platform to design specific pharmacokinetic performance into a molecule while optimizing potency and selectivity. The design of SLx-2101 and its preclinical program was directed to differentiate SLx-2101 from other PDE5 inhibitors based on the combined features of potency and duration of action in excess of 24 hours. The development plan for SLx-2101 includes a number of conditions related to endothelial dysfunction including male erectile dysfunction, pulmonary arterial hypertension, and congestive heart failure.