DCCR treatment resulted in statistically
significant decreases in body fat in subjects with Prader-Willi
Syndrome
Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of rare diseases, today announced that clinical data from
a Phase II study (PC025) of diazoxide choline controlled release
(DCCR) investigating the effects of DCCR treatment on hyperphagia
and fat loss in patients with Prader-Willi Syndrome (PWS) were
delivered today in a poster presentation at the Obesity Society
Meeting 2018, taking place this week in Nashville, TN.
“While the hallmark characteristic of PWS is hyperphagia, PWS
patients also experience ectopic accumulation of body fat, obesity
and associated cardiometabolic complications, which is the leading
cause of death of PWS patients,” said Anish Bhatnagar, M.D., Chief
Executive Officer of Soleno. “The clinical data presented at the
Obesity Society Meeting demonstrates that in addition to improving
hyperphagia, treatment with DCCR also leads to statistically
significant reductions in body fat in PWS patients. These data
provide further clinical evidence that DCCR has the potential to
treat both the behavioral and cardiometabolic symptoms that
challenge PWS patients. We are encouraged by these significant
impacts on body fat and continue to advance our ongoing DESTINY PWS
Phase III trial.”
Jennifer Miller, M.D., Associate Professor in the Division of
Pediatric Endocrinology at the University of Florida College of
Medicine and senior author of the study said, “PWS is complex and
challenging to treat as a neurobehavioral and metabolic disease. By
addressing both hyperphagia and the underlying metabolic disease
manifestations, DCCR has the potential to provide a treatment
option for patients that will simplify disease management and
improve quality of life, particularly as DCCR is suitable for once
daily oral dosing. We look forward to the results of Soleno’s
ongoing DESTINY PWS Phase III trial for DCCR.”
Neil Cowen, Ph.D., Senior Vice President of Drug Development,
Soleno Therapeutics, presented the poster presentation titled,
“Agonizing the KATP Channel with DCCR Results in Fat Loss in
Prader-Willi Syndrome Patients.”
Presentation highlights:
- Patients who received 10 weeks of treatment with DCCR
demonstrated statistically significant loss of total body fat mass,
without additional caloric restrictions.
- Treatment with DCCR resulted in a statistically significant
reduction in waist circumference, consistent with the loss of
visceral fat.
- The 4.2mg/kg dose, the high dose in this Phase II study and the
target dose in the ongoing DESTINY PWS Phase III trial, led to
greater loss of body fat compared to lower doses, with the
preferential loss of visceral and subcutaneous fat from the
legs.
An electronic version Soleno Therapeutics’ poster presentation
can be found on the Events & Presentations page of the
Company’s Investor Relations website:
http://investors.soleno.life/events-and-presentations/event-calendar.
About PWSThe 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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