Soleno Therapeutics Announces Successful End-of-Phase II Meeting with FDA for DCCR in Prader-Willi Syndrome
February 20 2018 - 8:00AM
Minutes Confirm Alignment on Soleno’s Planned
Phase III Clinical Trial
Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage
biopharmaceutical company developing novel therapeutics for the
treatment of rare diseases, today announced the successful
completion of and receipt of minutes from its End-of-Phase 2
Meeting with the US Food and Drug Administration (FDA) concerning
Diazoxide Choline Controlled-Release (DCCR) for the treatment of
Prader-Willi syndrome (PWS). PWS is a rare and complex genetic
neurobehavioral/metabolic disorder affecting appetite, growth,
metabolism, cognitive function, and behavior. The minutes
confirmed that the FDA and Soleno are aligned on all key aspects of
the Company’s planned Phase III clinical trial for DCCR, which will
be initiated in the near future.
“Alignment with the FDA on our Phase III
clinical trial design of DCCR in PWS allows us to confidently
initiate this study,” said Anish Bhatnagar, M.D., Chief Executive
Officer of Soleno. “If approved, we believe DCCR has the potential
to be a safe and effective treatment for PWS, a rare and
life-threatening disease with significant unmet needs.”
In the fourth quarter of 2017, Soleno raised
aggregate gross proceeds of approximately $15 million
through a private placement of the company’s common stock in order
to conduct the planned Phase III trial of DCCR in PWS.
Diazoxide choline has Orphan Drug Designation
for the treatment of PWS in the US and EU.
About PWSThe Prader-Willi Syndrome Association
USA (PWSA (USA)) estimates that one in 12,000 to 15,000 people have
PWS. The prevalence of PWS is similar across all geographies and
ethnicities. 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. Diazoxide choline has received
Orphan Drug Designation for the treatment of PWS in the US and
EU.
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, as an oral suspension, has been used for
decades in thousands of patients in a few rare diseases in
neonates, infants, children and/or adults, but not 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 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
in early 2018.
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 in early 2018.
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 Form 10-Q filed with the
Securities and Exchange Commission on November 14, 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 Ritchie LifeSci Advisors, LLC 212-915-2578
Soleno Therapeutics (NASDAQ:SLNO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Soleno Therapeutics (NASDAQ:SLNO)
Historical Stock Chart
From Sep 2023 to Sep 2024