Fispemifene Failed to Achieve Statistical Significance in Key Clinical Benefit Endpoints Despite Increase in Testosterone Levels
Company Will Focus on Internal Pipeline, Including Expanding Market Share for Vitaros® in Europe and NDA Re-Submission in the U.S. in Q3 2016
Conference Call / Webcast Today, Monday, March 28, 2016 at 9:00 a.m. ET
SAN DIEGO, CA, USA I March 28, 2016 I Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today 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 approximately 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.
While fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo (P < 0.0001 at both 4 and 8 weeks), the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint. Erectile function was assessed using the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire and Sexual Encounter Profile (SEP) diaries and low libido/desire was assessed using the Psychosexual Daily Questionnaire (PDQ).
Fispemifene was generally well-tolerated, and no new or significant safety issues arose from this study. Rates of adverse events were similar between groups with the majority of adverse events being mild or moderate. There were no serious adverse events experienced on fispemifene and there were very few discontinuations. There were no elevations in testosterone above the normal range, and no concerns related to consistent increases in hemoglobin, hematocrit or prostate-specific antigen.
“We are obviously disappointed with these results,” said Richard Pascoe, Chief Executive Officer of Apricus. “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.”
“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,” said Barbara Troupin, MD, Chief Medical Officer of Apricus.
The Company will host a conference call on Monday, March 28, 2016, at 9:00 a.m. Eastern Time to discuss the top-line results and the Company’s focus moving forward. To participate by telephone, please dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850. The live audio webcast can be accessed via the Investors section of the Company’s website at www.apricusbio.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for thirty days following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. 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. In September 2015, Apricus 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. Apricus currently has two product candidates, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon and fispemifene, a selective estrogen receptor modulator for the treatment of male urological conditions.
SOURCE: Apricus Biosciences
Post Views: 104
Fispemifene Failed to Achieve Statistical Significance in Key Clinical Benefit Endpoints Despite Increase in Testosterone Levels
Company Will Focus on Internal Pipeline, Including Expanding Market Share for Vitaros® in Europe and NDA Re-Submission in the U.S. in Q3 2016
Conference Call / Webcast Today, Monday, March 28, 2016 at 9:00 a.m. ET
SAN DIEGO, CA, USA I March 28, 2016 I Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today 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 approximately 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.
While fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo (P < 0.0001 at both 4 and 8 weeks), the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint. Erectile function was assessed using the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire and Sexual Encounter Profile (SEP) diaries and low libido/desire was assessed using the Psychosexual Daily Questionnaire (PDQ).
Fispemifene was generally well-tolerated, and no new or significant safety issues arose from this study. Rates of adverse events were similar between groups with the majority of adverse events being mild or moderate. There were no serious adverse events experienced on fispemifene and there were very few discontinuations. There were no elevations in testosterone above the normal range, and no concerns related to consistent increases in hemoglobin, hematocrit or prostate-specific antigen.
“We are obviously disappointed with these results,” said Richard Pascoe, Chief Executive Officer of Apricus. “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.”
“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,” said Barbara Troupin, MD, Chief Medical Officer of Apricus.
The Company will host a conference call on Monday, March 28, 2016, at 9:00 a.m. Eastern Time to discuss the top-line results and the Company’s focus moving forward. To participate by telephone, please dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850. The live audio webcast can be accessed via the Investors section of the Company’s website at www.apricusbio.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for thirty days following the live call.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. 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. In September 2015, Apricus 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. Apricus currently has two product candidates, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon and fispemifene, a selective estrogen receptor modulator for the treatment of male urological conditions.
SOURCE: Apricus Biosciences
Post Views: 104
