Correcting & Replacing -- Soleno Therapeutics Announces DCCR Data Presentation at the Foundation for Prader-Willi Research Symposium
04 Outubro 2023 - 7:16PM
Soleno Therapeutics, Inc. (Soleno or the Company) (NASDAQ: SLNO), a
clinical-stage biopharmaceutical company developing novel
therapeutics for the treatment of rare diseases, today announced an
oral presentation at the Foundation for Prader-Willi Research
(FPWR) 2023 Research Symposium, being held October 5-6, 2023, in
Denver, Colorado. The presentation features results from the
recently completed randomized withdrawal period of Study C602, a
long-term treatment study of DCCR (Diazoxide Choline)
Extended-Release tablets for the treatment of Prader-Willi syndrome
(PWS).
Presentation details can be found below:
FPWR 2023 Research Symposium
Title: |
Rationale for and Results from a
Randomized Withdrawal Period Following Long-Term Administration of
Diazoxide Choline Extended-Release Tablets to People with
Prader-Willi Syndrome |
Presenter: |
Jennifer L. Miller, M.D.
(University of Florida) |
Format: |
Oral Presentation |
Date/Time: |
Thursday, October 5, 2023 at 2:00
– 2:20 PM MDT |
Location: |
Westin, Downtown Denver |
Livestream: |
Click Here |
About PWSThe Prader-Willi Syndrome Association
USA estimates that PWS occurs in one in every 15,000 live births.
The hallmark symptom of this disorder is hyperphagia, a chronic and
life-threatening feeling of intense, persistent hunger, food
pre-occupation, extreme drive to food seek and consume food that
severely diminish the quality of life for patients with PWS 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.,
obesity, diabetes, cardiovascular disease) and mortality (e.g.,
stomach rupture, 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 and 92.9% rated body composition as either 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 DCCR (Diazoxide Choline) Extended-Release
TabletsDCCR is a novel, proprietary extended-release
dosage form containing the crystalline salt of diazoxide and 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, diazoxide
choline and DCCR in patients with PWS. The DCCR development program
is supported by data from five completed Phase 1 clinical studies
in healthy volunteers and three completed Phase 2 clinical studies,
one of which was in patients with PWS. In the PWS Phase 3 clinical
development program, 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 other metabolic
parameters. Diazoxide choline has received Orphan Drug Designation
for the treatment of PWS in the U.S. and E.U., and Fast Track
Designation in the U.S.
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 extended-release tablets, a once-daily oral tablet
for the treatment of PWS, recently completed its Phase 3
development program to support a planned NDA submission. For more
information, please visit www.soleno.life.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. All
statements other than statements of historical facts contained in
this press release are forward-looking statements, including
statements regarding the potential receipt of gross proceeds from
the warrant financing under the Securities Purchase Agreement,
management’s assessment of the top-line data results from the
randomized withdrawal period, and the timing and pathway of the
regulatory process and clinical development path for seeking
approval of DCCR for the treatment of PWS. In some cases, you can
identify forward-looking statements by terms such as "may," "will,"
"should," "expect," "plan," "anticipate," "could," "intend,"
"target," “goal,” "project," "contemplates," "believes,"
"estimates," "predicts," "potential" or "continue" or the negative
of these terms or other similar expressions. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions,
including the risks and uncertainties associated with market
conditions, as well as risks and uncertainties inherent in Soleno’s
business, including those described in the company's prior press
releases and in the periodic reports it files with the U.S.
Securities and Exchange Commission. The events and circumstances
reflected in the company's forward-looking statements may not be
achieved or occur and actual results could differ materially from
those projected in the forward-looking statements. Except as
required by applicable law, the company does not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Corporate Contact:Brian RitchieLifeSci
Advisors, LLC212-915-2578
Soleno Therapeutics (NASDAQ:SLNO)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Soleno Therapeutics (NASDAQ:SLNO)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024