Apricus Biosciences Completes Enrollment in Phase 2b Clinical Trial for Fispemifene in Men with Symptomatic Secondary Hypogonadism

SAN DIEGO, Oct. 28, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced completion of enrollment in the company's Phase 2b clinical trial to evaluate its novel product candidate, fispemifene, a selective estrogen receptor modulator ("SERM"), for the treatment of symptomatic male secondary hypogonadism also known as "low testosterone." The study enrolled 161 patients across 15 sites in the United States. Consistent with previous guidance, Apricus remains on track to report top-line Phase 2b data during the first quarter of 2016.

The primary endpoint of the study will measure improvements in erectile function from a baseline measurement period, with key secondary endpoints assessing additional sexual symptoms using Patient Reported Outcome ("PRO") measures. The study will also assess safety and tolerability along with relevant pharmacodynamic and pharmacokinetic parameters to evaluate the ability of fispemifene to endogenously increase the serum testosterone level. 

"I am very pleased with the enthusiasm and hard work by our investigators and their site staff, which has enabled us to remain on track with our enrollment goals, and puts us in a position to have top-line data sometime before the end of first quarter next year," said Barbara Troupin, MD, Chief Medical Officer of Apricus Biosciences. "Apricus' development goals for fispemifene are focused on demonstrating symptomatic benefits in men with secondary hypogonadism. This current trial is focused on improving sexual symptomatology, but subsequent trials will look at other prevalent symptoms in this patient population as well. We seek to demonstrate that fispemifene's novel mechanisms of action will provide additional and innovative treatment options to symptomatic men suffering from this condition to support one or more regulatory applications in the U.S. market. The multi-indication development program is designed to explore additional clinical benefits of fispemifene in other urological conditions where there is currently an unmet need."

Dr. Troupin continued, "Since inappropriate use of testosterone replacement products is of concern to the FDA, we believe our development strategy, which characterizes an appropriate patient population and a treatment approach based on alleviating prevalent symptoms in men with androgen deficiency, positions fispemifene favorably from both a clinical and a regulatory perspective. If successful, the ability to demonstrate meaningful clinical benefits, in a well-tolerated oral formulation, would represent a significant treatment benefit and an attractive alternative to existing treatments."

Phase 2b Trial Design

The Phase 2b proof-of-concept clinical trial is a randomized, double-blind, placebo-controlled, parallel arm, multi-center study in 160 hypogonadal men aged 18 to 64 who present with sexual dysfunction related to secondary hypogonadism, or low levels of testosterone. The study will evaluate the safety and tolerability of oral fispemifene, and will assess the effects of treatment on the sexual symptoms using PRO endpoints. The study will also assess relevant pharmacodynamic and pharmacokinetic parameters to evaluate the ability of fispemifene to endogenously increase the serum testosterone level. 

About Male Hypogonadism

Male hypogonadism or low testosterone is identified as total testosterone less than 300 ng/dL in healthy men. Based on the Hypogonadism in Males (HIM) study, hypogonadism is estimated to affect up to 39% of men over the age of 45 in the United States of which 66% present with one or more symptoms, including erectile dysfunction, decreased libido, weakness, decreased bone density, fatigue and decreased lean body mass. Currently approved treatment options include topical and injectable testosterone replacement therapies.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus recently completed enrollment in its Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus has completed a Phase 2a trial for RayVa, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. Apricus' lead commercial product, Vitaros®/™, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals) and Mylan NV. Apricus' second-generation room temperature Vitaros is currently under development.

For further information on Apricus, visit http://www.apricusbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: Apricus' development activities for fispemifene, including a development pathway and its ability to move fispemifene into later stage clinical development; the timing and results of the Phase 2b clinical trial to evaluate fispemifene for the treatment of symptomatic male secondary hypogonadism; the size of the patient population suffering from symptomatic male secondary hypogonadism; and the potential timing of any new drug application, or NDA, submission. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the timing and results of the ongoing Phase 2b clinical trial of fispemifene, Apricus' ability to receive feedback from the FDA on the development of fispemifene and, based on such feedback, further develop fispemifene for the treatment of symptomatic male secondary hypogonadism or other urological conditions, as well as the timing of such events; Apricus' ability to carry out further clinical studies for fispemifene, as well as the timing and success of the results of such studies; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; Apricus' ability to obtain the requisite governmental approval for fispemifene; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.

CONTACT: Matthew Beck
         mbeck@troutgroup.com
         The Trout Group
         (646) 378-2933

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