Strategic Science and Technologies Initiates Phase 2 Study to Evaluate Topical Sildenafil in Women with Female Sexual Arousal Disorder

SST-6007 is a first-in-class topical sildenafil product candidate in
development as an over-the-counter treatment for Female Sexual Arousal
Disorder

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Strategic
Science and Technologies LLC (SST)
, a clinical stage biotechnology
company developing novel topical formulations of known pharmaceutical
products, announced the initiation of a Phase 2 clinical
proof-of-concept trial of SST-6007, a first-in-class topical product
candidate in development for the treatment of Female Sexual Arousal
Disorder (FSAD). SST-6007 contains sildenafil citrate, the active drug
component in Viagra®, which is currently marketed by Pfizer for the
treatment of erectile dysfunction in men.

“The need for FSAD treatments has never been clearer than it is now,
with the demands for new therapies to treat sexual dysfunction in women
gaining widespread public support. We believe the development of
SST-6007 is a very important step in addressing this critical unmet
need. Following encouraging results from our Phase 1 study, we are
pleased to continue to advance this important treatment that could
positively impact the lives of the many women who suffer from FSAD,”
said Eric T. Fossel, Scientific Founder and Chief Executive Officer of
SST.

The Phase 2, double-blind, placebo-controlled, two-way crossover
clinical trial will evaluate the efficacy and safety of SST-6007 in
women with FSAD following a single 2 gram dose (100 mg sildenafil
citrate) applied to the local vulvar-vaginal target site. The study will
enroll 30 women with FSAD, 15 pre-menopausal and 15 post-menopausal, and
will assess physiological genital response (as measured using a vaginal
photoplethysmograph) and subjective sexual arousal (as measured by a
Likert-scale questionnaire and Arousometer device). Secondary objectives
will include time to onset of action and safety. The single-center study
is being conducted at the Sexual Psychophysiology Laboratory at the
University of Texas Austin. More information about the Phase 2 study
with SST-6007 can be found on ClinicalTrials.gov
under the Identifier number NCT02570282.

Principal Investigator for the study, Cindy M. Meston, Ph.D., Professor,
The University of Texas at Austin, Director, The Sexual Psychophysiology
Laboratory commented, “There are several different types of sexual
problems women experience. The drug that was recently approved by the
FDA aims to help women with desire problems. The drug being tested in my
lab, SST-6007, is designed to help women who have problems becoming
sexually aroused. Many women report wanting to engage in sex but find
that their bodies do not respond sexually like they once did and this
often dramatically decreases their overall sexual pleasure. If SST-6007
works as we expect it will, it could have far-reaching consequences for
women with sexual arousal dysfunction.”

In a recently completed Phase 1 trial in healthy post-menopausal women,
SST-6007 was found to be safe and well tolerated with no dermal
irritation reported following a clinically relevant dose. Systemic side
effects were mild and transient in nature with no clinically meaningful
difference observed between the SST-6007 and topical placebo treatment
groups. The concentration of sildenafil citrate detected in the blood
after a single application of SST-6007 was significantly less than
concentrations reported from oral administration of sildenafil citrate
at comparable dose strengths. These data demonstrate significant
penetration of sildenafil citrate across the vulvar and vaginal
epithelium, supporting a fast onset of action and ‘on-demand’ treatment
indication for SST-6007.

About Female Sexual Arousal Disorder

Female sexual arousal disorder (FSAD) is characterized by a persistent
or recurrent inability to attain or maintain sufficient sexual
excitement or genital lubrication and swelling, causing personal
distress. While FSAD can affect women of all ages, the prevalence of
FSAD is primarily associated with vascular risk factors and menopause,
with an estimated 40% of post-menopausal women experiencing difficulties
with lubrication. Because there are currently no FDA-approved therapies
available for the treatment of FSAD, topical lubricants and estrogen
creams are often recommended to alleviate symptoms; unfortunately
however these remedies are often ineffective in treating women with an
arousal disorder.

About SST-6007

SST-6007, developed with SST’s proprietary KNOSIS™ technology, is a
patented topical cream product containing 5% sildenafil citrate by
weight. The marketed oral formulation of sildenafil citrate, Viagra®, is
a specific PDE-5 inhibitor that enhances nitric-oxide mediated
vasodilation of blood vessels in the corpus cavernosum of the penis, and
is evidenced to act analogously in the smooth muscle cells of the female
clitoris, vagina and labia minora. Viagra® is available as a
prescription drug for men with erectile dysfunction; however it is not
approved for use in women. Its use is contraindicated in some men due to
its systemic vasodilatory properties that result in decreased supine
blood pressure. In patients without these cardiovascular risk factors,
mild and temporary side effects include headache, facial flushing, upset
stomach and nausea. The FDA-approved labeling for PDE-5 inhibitors also
includes warnings about the risk for sudden loss of vision in one or
both eyes and sudden decrease or loss of hearing.

SST is concurrently developing an identical topical sildenafil citrate
preparation (i.e. SST-6006) for men with erectile dysfunction, which is
currently in Phase 2 clinical testing.

About KNOSIS™

SST’s novel topical technology, KNOSIS™, is based on the pioneering work
of its Scientific Founder, Eric T. Fossel, formerly in the Biochemistry,
Biophysics and Radiology Departments at Harvard Medical School. Due to
the skin’s highly protective barrier, the stratum corneum, success with
topical delivery approaches has been mostly limited to smaller,
uncharged molecules. SST’s proprietary topical delivery technology
overcomes these historical challenges through at least two novel
features. First, the KNOSISTM formulation technology produces
a hostile biophysical environment for the active pharmaceutical
ingredient (API), increasing its free energy and creating a positive
chemical potential which drives the API from the delivery vehicle into
the tissue. Second, KNOSIS™ prevents the formation of hydrogen bonds
between the API and the stratum corneum, which can inhibit the API from
permeating into the tissue. These two complementary actions support
SST’s efforts to achieve the desired local therapeutic effect in the
target tissue and, due to the minimal uptake of the drug into the
bloodstream, greatly reduce or eliminate any known side effects
associated with its systemic absorption.

About Strategic Science and Technologies LLC

Strategic Science and Technologies LLC (SST) is a clinical-stage
biotechnology company developing first-in-class topical formulations of
known pharmaceutical products. SST has been successful in delivering
several highly-charged molecules across the skin in therapeutic areas
including pain, dermatology, and men’s and women’s sexual health. By
working only with FDA-approved drugs, SST utilizes the 505(b)(2)
regulatory pathway to accelerate the development of topical formulations
and is advancing a portfolio of both OTC and prescription drug product
candidates. SST remains privately funded by its original private
investors, with a business strategy to partner its products with
experienced pharmaceutical companies prior to initiation of the pivotal
Phase 3 registration trials. www.strategicscience.com

Contacts

Media Contact:
MacDougall Biomedical Communications
Hunter
Marshall, 781-235-3060
hmarshall@macbiocom.com
or
Kari
Watson, 781-235-3060
kwatson@macbiocom.com