Soleno Therapeutics Announces Issuance of New U.S. Patent for DCCR Covering Treatment of Low Lean Body Mass in Prader-Willi S...
September 04 2018 - 8:00AM
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 (No. 10/058,557) from the U.S. Patent and Trademark Office
related to the use of pharmaceutical formulations of diazoxide and
diazoxide choline to increase lean body mass and the lean body
mass/fat mass ratio in patients with Prader-Willi syndrome (PWS).
PWS is a rare and complex genetic neurobehavioral and metabolic
disorder affecting appetite, body composition, growth, metabolism,
cognitive function, and behavior.
“This patent further strengthens Soleno’s intellectual property
portfolio in the treatment of PWS,” said Anish Bhatnagar, M.D.,
Chief Executive Officer of Soleno Therapeutics. “Low lean body mass
is a significant challenge for PWS patients, impacting both
physical activity and metabolism. We hope that treatment with DCCR
will result in increases in lean body mass, and are currently
evaluating this as an outcome measure in our ongoing Phase III
trial.”
Low muscle mass, reflected in low lean body mass and weak
muscles (hypotonia), are universal characteristics of PWS.
Together, these limit the ability of PWS patients to carry
out day-to-day activities and lead active lifestyles. Since
PWS patients have lower muscle mass, they use less energy at rest
and when active, and therefore need to consume fewer calories per
day to meet their energy needs than do others. In Soleno’s
Phase II study of DCCR in PWS patients, statistically significant
improvements in lean body mass were observed.
Enrollment in Soleno’s Phase III clinical trial for DCCR in PWS
has commenced at multiple sites in the U.S. The U.S. Food and
Drug Administration has designated the investigation of DCCR for
the treatment of PWS a Fast Track development program. In addition,
Diazoxide choline has received orphan drug designations in the U.S.
and E.U.
About PWS The Prader-Willi Syndrome Association
USA estimates that one in 12,000 to 15,000 people in the U.S. have
PWS. The hallmark symptom of this disorder is hyperphagia, a
chronic feeling of insatiable hunger that severely diminishes the
quality of life for PWS patients and their families. Additional
characteristics of PWS include behavioral problems, cognitive
disabilities, low muscle mass and 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 (e.g., stomach
rupture, obesity, diabetes, cardiovascular disease) and mortality
(e.g., choking, accidental death due to food seeking behavior). In
a global survey conducted by the Foundation for Prader-Willi
Research, 96.5% of respondents (parent and caregivers) rated
hyperphagia 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. Diazoxide choline
has Orphan Drug Designation for the treatment of PWS in the U.S.
and E.U.
About Diazoxide Choline Controlled-Release
Tablet Diazoxide choline controlled-release tablet is a
novel, proprietary extended-release, crystalline salt formulation
of diazoxide, which is administered once-daily. The parent
molecule, diazoxide, has been used for decades in thousands of
patients in a few rare diseases in neonates, infants, children and
adults, but has not been approved for use in PWS. Soleno conceived
of and established extensive patent protection on the therapeutic
use of diazoxide and DCCR in patients with PWS. The DCCR
development program is supported by positive data from five
completed Phase I clinical trials in various metabolic indications
or in healthy volunteers and three completed Phase II clinical
trials, one of which was in PWS patients. In the PWS Phase II
clinical trial, DCCR showed promise in addressing hyperphagia, as
well as several other hallmark symptoms of PWS.
About Soleno Therapeutics, Inc. Soleno is
focused on the development and commercialization of novel
therapeutics for the treatment of rare diseases. Soleno’s lead
candidate, DCCR, a once-daily oral tablet for the treatment of PWS,
is currently being evaluated in a Phase III clinical development
program.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 complete the Phase III clinical development program of DCCR in
PWS in 2019.
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 press release will prove to be accurate. Additional factors
that could materially affect actual results can be found in
Soleno’s annual and quarterly reports filed with the Securities and
Exchange Commission, 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.
Corporate Contact:Brian Ritchie LifeSci
Advisors, LLC 212-915-2578
Media Contact: Allison Blum, Ph.D.LifeSci
Public Relations646-627-8383
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