Soleno Therapeutics Announces Oral Presentation featuring DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome at ENDO 2024
22 Mai 2024 - 10:05PM
Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a
clinical-stage biopharmaceutical company developing novel
therapeutics for the treatment of rare diseases, today announced
that data from the randomized withdrawal period of Study C602 of
DCCR (diazoxide choline) extended-release tablets in Prader-Willi
Syndrome (PWS) will be featured in an oral presentation at the
Annual Meeting of the Endocrine Society (ENDO 2024), being held
June 1-4, 2024 in Boston, Massachusetts.
Details of the presentation are as follows:
ENDO 2024
Title: |
Withdrawal of DCCR (Diazoxide Choline) Extended-Release Tablets
Worsens Hyperphagia and Increases Weight and BMI in a 16-week
Double-blind, Placebo-controlled, Randomized Withdrawal Period in
Patients with Prader Willi Syndrome |
Format: |
Oral Presentation |
Session: |
OR31. Adipose Tissue, Appetite,
and Obesity: Updates on Central Regulation of Appetite and
Feeding |
Date/Time: |
Sunday, June 2, 2024 at 2:45 –
3:00 pm ET |
Presenter: |
Evelien Gevers, M.D., Ph.D.
(Barts Health NHS Trust and Queen Mary University London) |
|
|
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 for 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 and Breakthrough Designations 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 (diazoxide choline)
extended-release tablets, a once-daily oral tablet for the
treatment of Prader-Willi syndrome (PWS), recently completed its
Phase 3 development program to support a planned NDA submission.
For more information, please visit www.soleno.life.
Corporate Contact:Brian
RitchieLifeSci Advisors, LLC212-915-2578
Soleno Therapeutics (NASDAQ:SLNO)
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