CRANBURY, N.J., Nov. 1, 2016 /PRNewswire/ --
- Both Phase 3 Reconnect Studies of bremelanotide for
hypoactive sexual desire disorder (HSDD) in premenopausal women met
the pre-specified co-primary efficacy endpoints of improvement in
desire and decrease in distress associated with low sexual desire
as measured using validated patient-reported outcome
instruments:
- The Female Sexual Function Index: Desire Domain (FSFI-D)
showed a statistically significant increase for bremelanotide
compared to placebo in both trials
- Study 301: Mean change of 0.54 vs. 0.24, median change of
0.60 vs. 0.00, p=0.0002; and,
- Study 302: Mean change of 0.63 vs. 0.21, median change of
0.60 vs. 0.00, p<0.0001
- The Female Sexual Distress Scale - Desires/Arousal/Orgasm
(FSDS-DAO) Item 13 showed a statistically significant reduction in
distress related to low sexual desire for bremelanotide compared to
placebo in both trials
- Study 301: Mean change of -0.74 vs. ‑0.35, median change of
-1.0 vs. 0.0, p<0.0001; and,
- Study 302: Mean change of -0.71 vs. -0.41, median change of
-1.0 vs. 0.0, p=0.0057
- New Drug Application (NDA) to the FDA targeted for the
second half of 2017
- Conference call and audio webcast at 9:00 am ET tomorrow, November 2
Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical
company developing targeted, receptor-specific peptide therapeutics
for the treatment of diseases with significant unmet medical need
and commercial potential, today announced positive, statistically
significant top-line results from the Reconnect Studies, its Phase
3 clinical trial program of lead drug candidate bremelanotide. The
Reconnect Studies, investigating bremelanotide as an on-demand
treatment for premenopausal women diagnosed with hypoactive sexual
desire disorder ("HSDD"), met the pre-specified co-primary efficacy
endpoints in both Phase 3 clinical trials.
"We could not be more pleased with the bremelanotide Phase
3 co-primary endpoint results. Women with HSDD using
bremelanotide had clinically meaningful and statistically
significant improvements in their desire and associated distress
which are the defining clinical issues for an HSDD diagnosis," said
Carl Spana, Ph.D., President and
Chief Executive Officer of Palatin. "I am especially grateful to
all of the women who volunteered to be a part of these
studies. I would also like to thank Palatin's employees and
the many consultants and third-parties that contributed to the
advancement of bremelanotide."
Johna D. Lucas, M.D., Chief
Medical Officer of Palatin, said, "In Phase 3 trials bremelanotide
was used as needed by premenopausal women with HSDD, with a single
dose self-administered in anticipation of sexual activity. The
Phase 3 studies demonstrated that bremelanotide provided a
meaningful benefit for those patients who responded to the drug
candidate. We look forward to the opportunity to provide a new and
differentiated treatment option to the many women suffering from
HSDD."
"Hypoactive sexual desire disorder is the most prevalent form of
female sexual dysfunction," said Sheryl A.
Kingsberg, Ph.D., Professor of Reproductive Biology at
Case Western Reserve University School
of Medicine, Division Chief, OB/GYN Behavioral Medicine, at
University Hospitals Cleveland Medical Center, and a clinical
investigator in the Reconnect Studies. "The distress
component of HSDD reflects the profound negative impact that this
condition can have on women's self-image, relationships and quality
of life well outside the bedroom. In the Phase 3 trials we saw
significant reduction in distress with use of bremelanotide."
Palatin expects to present additional results from the Reconnect
Studies at future sexual medicine and women's health conferences
and in peer reviewed journal publications.
Reconnect Studies Top-line Results Overview
The Reconnect Studies consist of two randomized, double-blinded,
placebo-controlled Phase 3 studies, comparing the efficacy and
safety of bremelanotide versus placebo in premenopausal women
diagnosed with HSDD. The Reconnect Studies randomized 1,267 women
with HSDD. The primary efficacy analysis population was the
modified intent-to-treat (MITT) patient population, consisting of
1,202 women with HSDD in the United
States and Canada. Patients self-administered either
1.75 mg of bremelanotide or placebo as needed in anticipation of
sexual activity. The double blind or efficacy portion of each study
consisted of a 24-week treatment evaluation period. The open-label
safety extension portion of the Reconnect Studies is ongoing.
Based on discussions with the FDA, it was decided that the
co-primary endpoints for the Phase 3 clinical trials were the
Female Sexual Function Index: Desire Domain (FSFI-D) and Female
Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13.
Satisfying sexual events is a secondary endpoint. The FSFI-D is a
validated patient reported outcome measurement tool of sexual
desire in the context of overall sexual function. The FSDS-DAO Item
13 is a validated patient reported outcome measurement tool of
distress related to sexual dysfunction, measuring personal distress
associated with low sexual desire.
Clinical significance of co-primary endpoint study results was
evaluated by an independent committee using multiple anchors of
patient assessment of benefit, consistent with discussions with the
FDA and guidance documents.
- Clinical Significance for the FSFI-D Subscale: Based on
application of three selected anchors, a median value of 0.6 was
set for defining clinical significance in baseline to endpoints
changes in FSFI-D subscale scores.
- Clinical Significance for the FSDS-DAO Item 13 Score: Based on
application of three selected anchors, a median value of 1.0 point
improvement in FSDS-DAO Item 13 scores was set for defining
clinical significance.
In the preliminary review of the overall safety population
(1,247 patients), bremelanotide appeared to be well tolerated. The
most frequent adverse event was nausea, which was generally mild in
nature. The safety profile of bremelanotide was consistent with
prior clinical experience, and no new or unusual safety issues were
identified.
Conference Call/Audio Webcast Information
Palatin will host a conference call and audio webcast on
Wednesday, November 2, 2016 at
9:00 a.m. Eastern Time. The
live conference call can be accessed by dialing (888) 516-2443
(domestic) or (719) 457-2651 (international), and entering
conference code 7590742. The audio webcast and replay can be
accessed by logging on to the "Investor/Webcasts" section of
Palatin's website at http://www.palatin.com. A telephone and
audio webcast replay will be available approximately one hour after
the completion of the call. To access the telephone replay,
dial (888) 203-1112 (domestic) or (719) 457-0820 (international),
and enter passcode 7590742. The audio webcast and telephone
replay will be available through November 9,
2016.
About Bremelanotide for HSDD
Palatin is developing bremelanotide as a subcutaneous,
on-demand, as needed treatment for premenopausal women diagnosed
with HSDD. Bremelanotide, which is a melanocortin 4 receptor
agonist drug candidate, is a synthetic peptide analog of the
naturally occurring hormone alpha-MSH (melanocyte-stimulating
hormone). In clinical studies bremelanotide is self-administered on
an as-needed (not chronic) basis in anticipation of sexual
activity.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential. Palatin's strategy is to develop products and
then form marketing collaborations with industry leaders in order
to maximize their commercial potential. For additional
information regarding Palatin, please visit Palatin's website at
www.Palatin.com.
Forward-looking Statements
Statements in this press release that are not historical facts,
including statements about future expectations of Palatin
Technologies, Inc., such as statements about clinical trial
results, potential actions by regulatory agencies including the
FDA, regulatory plans, development programs, proposed indications
for product candidates and market potential for product candidates,
are "forward-looking statements" within the meaning of Section 27A
of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private
Securities Litigation Reform Act of 1995. Palatin intends that such
forward-looking statements be subject to the safe harbors created
thereby. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that could cause Palatin's
actual results to be materially different from its historical
results or from any results expressed or implied by such
forward-looking statements. Palatin's actual results may differ
materially from those discussed in the forward-looking statements
for reasons including, but not limited to, results of clinical
trials, regulatory actions by the FDA and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully complete clinical trials, the length
of time and cost required to complete clinical trials and submit
applications for regulatory approvals, products developed by
competing pharmaceutical, biopharmaceutical and biotechnology
companies, commercial acceptance of Palatin's products, and other
factors discussed in Palatin's periodic filings with the Securities
and Exchange Commission. Palatin is not responsible for updating
for events that occur after the date of this press release.
References
Clayton AH et al., Bremelanotide for female sexual dysfunction
in premenopausal women: a randomized, placebo-controlled
dose-finding trial. Women's Health 12(3):325-337 (2016)
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SOURCE Palatin Technologies, Inc.