Soleno Therapeutics Announces Issuance of New U.S. Patent for DCCR in Treatment of Prader-Willi Syndrome
September 13 2017 - 8:00AM
Protection of Associated Claims into
2035
Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of rare diseases, announced today the issuance of a new
patent (9,757,384) from the U.S. Patent and Trademark Office
related to the use of pharmaceutical formulations of diazoxide and
its salts, such as diazoxide choline, to reduce one or more
aggressive behaviors in a subject with Prader-Willi syndrome (PWS)
or Smith-Magenis syndrome (SMS). PWS is a rare and complex
genetic neurobehavioral/metabolic disorder affecting appetite,
growth, metabolism, cognitive function, and behavior. SMS is a rare
disorder with a distinct genetic basis, but a natural history
similar to that of PWS.
“This patent will further strengthen the intellectual property
portfolio for DCCR, our lead product candidate, for the treatment
of PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of
Soleno Therapeutics. “Importantly, this most recent patent
will provide protection of associated claims into 2035. We
expect to leverage additional intellectual property opportunities
for DCCR over the coming months.”
Soleno expects to initiate a Phase III clinical trial of
Diazoxide Choline Controlled Release Tablet (DCCR) in PWS by the
end of 2017. The Company is currently finalizing the
design of a randomized, double-blind placebo-controlled study that
will treat approximately 100 patients. This study is
anticipated to take approximately 9-12 months to complete.
DCCR has Orphan Designation for the treatment of PWS in the
U.S.
About PWSPWS is a rare and complex genetic
neurobehavioral/metabolic disorder affecting appetite, growth,
metabolism, cognitive function and behavior. The committee on
genetics of the American Academy of Pediatrics states PWS affects
both genders equally and occurs in people from all geographic
regions: its estimated incidence is one in 15,000 to 25,000 births.
This disorder is typically characterized by hyperphagia, a chronic
feeling of insatiable hunger, behavioral problems, cognitive
disabilities, low muscle tone, short stature (when not treated with
growth hormone), the accumulation of excess body fat, developmental
delays, and incomplete sexual development. Hyperphagia, in
the absence of effective limitations to access to food, can lead to
morbid obesity. In a global survey conducted by the
Foundation for Prader-Willi Research, 96.5% of respondents (parent
and caregivers) rated hyperphagia, which is the unrelenting hunger
that severely diminishes the quality of life for patients and their
families, as the most important or a very important symptom to be
relieved by a new medicine. There are currently no approved
therapies to treat the hyperphagia/appetite, metabolic, cognitive
function, or behavioral aspects of the disorder.
About Diazoxide Choline Controlled-Release
TabletDiazoxide choline controlled-release tablet is a
novel, proprietary controlled-release, crystalline salt formulation
of diazoxide, which is administered once-daily. The parent
molecule, diazoxide, as an oral suspension, has been used for
decades in thousands of patients in a few rare diseases in
neonates, children and/or adults, but not in PWS. Essentialis
conceived of and is pursuing an extensive patent portfolio relating
to various aspects of the therapeutic use of diazoxide and DCCR in
patients with PWS. The DCCR development program is supported
by positive data from two completed Phase II clinical studies and
five completed Phase I clinical studies in various metabolic
indications, as well as a pilot study in PWS patients. In the
PWS pilot study, DCCR showed promise in addressing the hallmark
symptoms of PWS, most notably hyperphagia
About Soleno Therapeutics, Inc.Soleno
Therapeutics, Inc. is focused on the development and
commercialization of novel therapeutics for the treatment of rare
diseases. The company is currently advancing its lead
candidate, DCCR, a once-daily oral tablet for the treatment of PWS,
into a Phase III clinical development program at the end of 2017.
Soleno, through its wholly-owned subsidiary, Capnia, Inc.,
continues to market Capnia’s innovative medical device, the
CoSense® End-Tidal Carbon Monoxide (ETCO) monitor, which measures
ETCO and is used by hospitals to detect hemolysis in
newborns. It is expected that this product will be monetized
and will not be a focus for the company in the long
term.
For more information, please visit www.soleno.life.
Forward-Looking StatementsThis press release
contains forward-looking statements that are subject to many risks
and uncertainties. Forward-looking statements include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things, our ability
to initiate the Phase III clinical development program of DCCR in
PWS by the end of 2017. We may use terms such as "believes,"
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should," "approximately" or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Although we believe that we have
a reasonable basis for each forward-looking statement contained
herein, we caution you that forward-looking statements are not
guarantees of future performance and that our actual results of
operations, financial condition and liquidity, and the development
of the industry in which we operate may differ materially from the
forward-looking statements contained in this presentation. As a
result of these factors, we cannot assure you that the
forward-looking statements in this presentation will prove to be
accurate. Additional factors that could materially affect actual
results can be found in Capnia’s Form 10-Q filed with the
Securities and Exchange Commission on August 11, 2017, including
under the caption titled "Risk Factors." Capnia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Contact:Brian RitchieLifeSci Advisors,
LLC212-915-2578
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