Soleno Therapeutics to Present DCCR Clinical Data at Late Breaking Sessions of the European Society for Paediatric Endocrinol...
September 17 2018 - 8:00AM
Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of rare diseases will present two poster presentations
from studies of Soleno’s lead product candidate, diazoxide chloride
controlled release (DCCR) for the treatment of Prader-Willi
Syndrome (PWS) on September 29 at the 57th Annual European Society
for Paediatric Endocrinology Meeting. The meeting is taking place
September 27-29 in Athens, Greece.
The presentations will consist of clinical data from studies
examining the pharmacokinetics and glycemic impact of long term use
of DCCR in subjects with PWS.
Presentation Details
Title: |
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Pharmacokinetics of Diazoxide Choline Controlled-Release
Tablet, a Once Daily Treatment Being Evaluated for Patients with
Prader Willi Syndrome |
Date/Time: |
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Saturday, September 29,
2018 (12:45-13:45) |
Abstract Number: |
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LB-P8 |
Poster Session: |
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Late Breaking 2 |
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Title:
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Glycemic Impact
of Long Term Use of Diazoxide Choline Controlled-Release (DCCR)
Tablets in Patients with Prader Willi Syndrome or with Very High
Triglycerides |
Date/Time: |
|
|
Saturday, September 29,
2018 (12:45-13:45) |
Abstract Number: |
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LB-P3 |
Poster Session: |
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Late Breaking 2 |
About PWS The Prader-Willi Syndrome Association
USA estimates that one in 12,000 to 15,000 people in the US 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 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 received 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 studies in various metabolic indications
or in healthy volunteers and three completed Phase II clinical
studies, one of which was in PWS patients. In the PWS Phase II
study, DCCR showed promise in addressing hyperphagia, the hallmark
symptom of PWS, as well as several other symptoms such as
aggressive/destructive behaviors, fat mass and abnormal lipid
profiles.
About Soleno Therapeutics, Inc. Soleno is
focused on the development and commercialization of novel
therapeutics for the treatment of rare diseases. The company’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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