Du är här

2015-09-17

Apricus Biosciences, Inc.: Apricus Reports Top-Line Phase 2a Data for RayVa(TM), Its Topical Treatment for Raynaud's Phenomenon

Apricus Reaffirms Plans to Move RayVa Into Late-Stage Clinical Trials in
Patients With Scleroderma Who Also Suffer From Raynaud's Phenomenon

SAN DIEGO, Sept. 17, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc.
(Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in
urology and rheumatology, today announced top-line results from the
RayVa(TM)Phase 2a trial in patients with scleroderma who also suffer from
Raynaud's phenomenon ("Raynaud's"). The primary objective of this clinical
trial was to establish safety and tolerability and to look for
pharmacodynamic effects in this targeted Raynaud's population. The RayVa
Phase 2a trial was a randomized, double-blind, placebo-controlled trial that
enrolled approximately thirty-five subjects across four U.S. sites. The
clinical trial was based on an experimental design wherein subjects were
exposed to a cold challenge to assess blood flow (hemodynamic) and skin
temperature (thermodynamic) changes, by laser Doppler and thermography, as a
result of the vasoconstriction characteristic of Raynaud's. In each case,
subjects were exposed to a dose of placebo and a dose of one of three active
doses, and served as their own control.

Importantly, there were no significant safety or tolerability issues observed
in any dosing cohort. Moreover, while this exploratory study was not designed
or powered to show a statistically significant pharmacodynamics result, there
were subjects who demonstrated improvements in blood flow and/or hand
temperature across all dosing cohorts. Apricus believes that this data,
coupled with previously generated non-clinical data, supports moving RayVa
forward into future clinical trials designed to evaluate symptomatic effects
in subjects with Raynaud's secondary to scleroderma.

"This clinical trial was an important step for the company, and one in which
the company acquired additional pharmacodynamic data that will help inform
the future development of the product candidate. As this was the first in
human study in this patient population, we are pleased to have confirmed
safety and tolerability, as well as improvements in blood flow and skin
temperature in certain subjects. The next steps will be to continue
formulation development activities for at-home dosing, and complete study
planning for our future clinical trials," said Barbara Troupin, MD, Chief
Medical Officer of Apricus. "Looking forward, we will move RayVa into
later-stage clinical trials designed to address the symptoms of an acute
Raynaud's attack, which is an important regulatory endpoint for this
indication, as well as a clinically meaningful outcome for patients who
suffer from this debilitating disease."

"This patient population has been without meaningful treatment options to
address the acute symptoms of Raynaud's, which can include pain and
functional limitations in the hands and feet, impairing work and family
time," said Dr. Elena Schiopu, Professor of Rheumatology at the University of
Michigan in Ann Arbor. "As the lead investigator for this exploratory study,
I was very pleased with the insights we have gained about this novel compound
and how well it was tolerated by my patients, and I look forward to working
with Apricus on future clinical trials to address this unmet medical need."

Apricus intends to move RayVa into a later stage Phase 2 clinical trial in
2016. This clinical trial will be designed to assess safety and efficacy in
an at-home dosing setting evaluating a symptomatic response to the treatment
of an acute episode. To accomplish this, Apricus will complete development of
the clinical protocol for at-home dosing, finalize the RayVa formulation and
delivery system, and complete manufacturing of clinical trial materials.

About Raynaud's Phenomenon

Raynaud's phenomenon is characterized by vasoconstriction of the hands and
feet in response to cold or stress resulting in reduced blood flow and the
sensation of pain, which can be severe. Primary Raynaud's phenomenon, which
is not associated with an underlying medical condition, affects an estimated
3-5% of the U.S. population.1,2Secondary Raynaud's phenomenon is driven by an
underlying medical condition, such as scleroderma, lupus or rheumatoid
arthritis.2Symptoms may be severe and patients risk associated fingertip
ulcerations. There are about 75,000 to 100,000 adult patients with
scleroderma in the U.S.,3of which approximately 90% have secondary Raynaud's
phenomenon2. Approximately 80% of scleroderma patients are women.4Both
primary and secondary Raynaud's phenomenon disproportionately affects
women.5There is currently no approved therapy for Raynaud's phenomenon in the
United States, representing an unmet medical need.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing
innovative medicines in urology and rheumatology. Apricus has initiated a
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' European marketing partners for Vitaros include
Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda
Pharmaceuticals International GmbH and Recordati Ireland Ltd. (Recordati
S.p.A.). Apricus' second-generation room temperature Vitaros is currently
under development.

For further information on Apricus, visithttp://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 RayVa(TM), including a development pathway and its
ability to move RayVa into later stage clinical development; the timing and
results of future studies and clinical trials in any of Apricus' product
candidates; the size of the patient population suffering from primary or
secondary Raynaud's phenomenon; 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: its
ability to receive feedback from the FDA on the development of RayVa and,
based on such feedback, further develop RayVa for the treatment of Raynaud's
Phenomenon in patients with scleroderma, as well as the timing of such
events; Apricus' ability to carry out further clinical studies for RayVa, 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 RayVa; 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 atwww.sec.govor
without charge from Apricus.

References

1N Engl J Med. 2002; 347:1001-1008.

2Drugs 2007; 67: 517-525.

3Curr Opin Rheumatol 2012, 24:165-170. American College of Rheumatology
(http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions...).

4Medicine 2013; 92: 191-205.

5National Institutes of Health
(http://www.nhlbi.nih.gov/health/health-topics/topics/raynaud/atrisk).

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

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Apricus Biosciences, Inc. via Globenewswire

HUG#1952628

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.