Rexahn Pharmaceuticals, a biopharmaceutical company, has reported preliminary results for its sexual dysfunction drug candidate, Zoraxel, from a Phase IIa clinical study for the treatment of erectile dysfunction.
The double blind, randomized, placebo-controlled, dose ranging study found that human subjects treated with Zoraxel demonstrated improved erectile function as measured by changes over the international index of erectile function (IIEF) baseline score within the eight-week treatment period.
The study, which was designed to assess Zoraxel’s safety and preliminary efficacy in male subjects between the ages 18 to 65 with erectile dysfunction (ED), demonstrated a dose dependent treatment effect achieved by Zoraxel as assessed by the IIEF survey. Zoraxel was found to be safe and well tolerated, with no serious adverse events reported.
Furthermore, subjects treated with Zoraxel demonstrated improved erectile function and significant improvement in the quality of life measures. Planning is underway for the Phase IIb trial, which will include the sexual encounter profile survey, IIEF and quality of life study endpoints.
Chang Ahn, CEO of Rexahn, said: These clinical study results are very encouraging, and substantiate our position that the future of ED treatment lies in compounds that act on the brain and address the underlying condition. This is a departure from the current standard of care, PDE-5 inhibitors, which only target end organ erectile function. We believe that Zoraxel has the potential to establish a new standard of care for sexual dysfunction.