Apricus Bio Top-Line Results Don't Stand Up to Expectations

Health and Healthcare

Published: March 28, 2016 10:55 am

Last Updated: January 13, 2020 11:28 am

Apricus Biosciences Inc. (NASDAQ: APRI) led the bears in Monday’s trading session when top-line results did not stand up to expectations. The company announced top-line results from the Phase 2b proof-of-concept study of fispemifene in men with secondary hypogonadism and sexual dysfunction.

This study was a randomized, double-blind, placebo-controlled study enrolling roughly 160 men to assess safety and tolerability, as well as the ability of fispemifene to improve the sexual function outcomes of erectile function and low libido compared to placebo in men with secondary hypogonadism.

At 450 mg fispemifene demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo. However, the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

Richard Pascoe, chief executive of Apricus, commented:

We are obviously disappointed with these results. As a consequence of these results, we will discontinue all development of fispemifene in symptomatic secondary hypogonadism, and focus our resources on our other homegrown pipeline assets. Specifically, we will focus on growing ex-U.S. Vitaros revenues, seeking U.S. Vitaros approval in 2017, and advancing RayVa with a Phase 2 clinical development program. We believe that focusing on these higher return assets, along with streamlining the organization and reducing our operating expenses, is in the best interest of shareholders.