Apricus
Biosciences, Inc. 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(R)/(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.
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