Apricus Biosciences Completes Enrollment in Phase 2b Clinical Trial for Fispemifene in Men with Symptomatic Secondary Hypogonadism
(Thomson Reuters ONE) -
Apricus Expects to Report Top-Line Phase 2b Data in Q1 2016
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((TM)), 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(®/(TM)), 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(at)troutgroup.com
The Trout Group
(646) 378-2933
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apricus Biosciences, Inc. via GlobeNewswire
[HUG#1961937]
Unternehmensinformation / Kurzprofil:
Datum: 28.10.2015 - 12:00 Uhr
Sprache: Deutsch
News-ID 430096
Anzahl Zeichen: 9038
contact information:
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