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

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.

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Barbara Troupin, M.D., chief medical officer of Apricus, added:

While we did see statistically meaningful changes in testosterone levels into the low normal ranges with fispemifene, the compound’s ability to increase those levels sufficiently to demonstrate clinical benefit is limited, and may be an issue with the entire SERM class. The regulatory benchmark for approval of a compound in secondary hypogonadism in men is the achievement of a symptomatic clinical benefit, using patient-reported outcome (PRO) measures in a defined patient population. Achievement of biochemical or PK normalization of testosterone into the low normal range is not sufficient for regulatory purposes.

Shares of Apricus were last seen down 49% at $0.68, with a consensus analyst price target of $2.67 and a 52-week trading range of $0.61 to $1.99.