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 (9,782,416) from the U.S. Patent and Trademark Office
related to the use of pharmaceutical formulations of diazoxide to
treat hyperphagia in a subject with Prader-Willi syndrome (PWS).
PWS is a rare and complex genetic neurobehavioral/metabolic
disorder affecting appetite, growth, metabolism, cognitive
function, and behavior.
“This patent further strengthens our intellectual property
portfolio in the treatment of PWS,” said Anish Bhatnagar, M.D.,
Chief Executive Officer of Soleno Therapeutics. “Importantly,
it covers the treatment of hyperphagia, one of the highest priority
unmet needs in PWS, and the primary endpoint of our planned Phase
III study of our lead product candidate, DCCR. Moving forward, we
intend to continue pursuing opportunities to protect and expand our
intellectual property estate.”
Soleno expects to initiate the Phase III clinical development
program 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 PWS
PWS 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 live 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 can lead to
significant morbidities (i.e., stomach rupture, obesity, diabetes,
cardiovascular disease) and mortality (i.e., choking, accidental
death due to food seeking behavior, etc.). 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
Tablet
Diazoxide 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 six
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. DCCR has received
Orphan Drug Designation from the US FDA for the treatment of
PWS.
About Soleno Therapeutics, Inc.
Soleno Therapeutics, Inc. (Soleno) 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 devices,
including 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 CoSense 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 Statements
This 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
Soleno’s Form 10-Q filed with the Securities and Exchange
Commission on August 11, 2017, including under the caption titled
"Risk Factors." Soleno expressly disclaims any intent or obligation
to update these forward-looking statements, except as required by
law.
Contact:
Brian RitchieLifeSci Advisors, LLC 212-915-2578
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