Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders, is
presenting data today describing the results of a retrospective
literature review on patients with autism spectrum disorder (ASD),
Fragile X syndrome (FXS), and 22q11.2 deletion syndrome (22qDS)
conducted to determine symptomatic overlap between these disorders.
The data indicate that patients with ASD, FXS, and 22qDS share a
constellation of sociobehavioral symptoms and that the pharmacology
of CBD is broad, continues to be defined, and may prove to be
beneficial in addressing important behavioral symptoms of these
conditions.
The poster, entitled Common Behavioral Features of
Autism, Fragile X Syndrome, and 22q11.2 Deletion Syndrome, is being
presented on September 5th and 6th at the 22nd Society for
the Study of Behavioural Phenotypes (SSBP) Research Symposium
at Aston University in Birmingham, UK. A copy of the poster is
available on the Zynerba corporate website at
http://zynerba.com/publications/.
Honey Heussler, MBBS, FRACP, MRCPCH, PGCAP, DM,
Associate Professor, University of Queensland and Medical Director
Child Development, Children’s Health Queensland is presenting data
showing that patients with ASD, FXS, and 22qDS share a
constellation of sociobehavioral symptoms that includes anxiety,
which may lead to social avoidant behavior, aggression,
irritability, attention deficits, and poor communication. Dr.
Heussler is presenting the poster from 12:40 – 1:45 British Summer
Time (BST) on September 5th and 6th, 2019.
“Those of us who care for patients and families
contending with certain neuropsychiatric dysfunction understand
that there are significant shared sociobehavioral symptoms between
such disorders, though until now no review has been conducted to
examine or clarify the overlap,” said Dr. Heussler. “These data on
the shared behaviors between ASD, FXS and 22qDS are important to
understanding disease impact, patient care, and the development of
potential treatments. One such potential treatment being studied in
well-controlled clinical trials is a proprietary gel formulation of
CBD, which has diverse pharmacologic effects and may prove to be
important in these neuropsychiatric disorders.”
Based on insights from Company data, a search of
the PubMed database was conducted using the terms “behavior,”
“behavioral symptoms,” “autism spectrum disorder,” “ASD,” “Fragile
X Syndrome,” “FXS,” “22q11.2 deletion syndrome,” “parents,”
“caregivers,” and “CBD and treatment of anxiety” with no
restriction on date or publication type. Records were then analyzed
for relevance. The most common behavioral manifestations across all
conditions are anxiety-related, such as social avoidance,
aggression, irritability, attention deficits, stereotypy, poor
communication, and social unresponsiveness.
ASD
Anxiety-related symptoms are common in patients
with ASD with up to 84% of children experiencing some degree of
debilitating anxiety. Rates of physician-diagnosed anxiety
disorders in these patients range from 42% to 55% and may include
simple phobias, generalized anxiety disorder, separation anxiety
disorder, obsessive-compulsive disorder, and social phobias.
Comorbid anxiety disorders can be associated with behaviors such as
aggression/irritability and isolation from same-age peers (due to
bullying/victimization in school). Inattention and hyperactivity
are often present in Attention Deficit-Hyperactivity Disorder and
ASD.
FXS
In FXS, severe cognitive and social impairments are
more common in males than in females. FXS usually has profound
effects on the life of patients (comorbid conditions, social
impairment) as well as their caregivers and families (mental
health, absence from work/school). Anxiety and social avoidance are
considered core features of FXS; further, anxiety can be thought of
as a foundational precipitant to social avoidance. Social avoidance
encompasses behaviors that may include seeking isolation, lack of
interaction, social escape, and gaze avoidance that distance the
individual from his/her social counterparts.
22qDS
The most common behavioral/psychiatric diagnoses in
children with 22qDS were ADHD, ASD, and anxiety. Up to one-third of
patients with 22qDS will develop schizophrenia or schizo-affective
disorder by late adolescent and early adulthood. The emergence of
social deficits during adolescence can represent a major source of
disability in some individuals with 22qDS. Cross-sectional studies
(observational research that analyzes data collected at one given
point of time across a sample population) show that
children with 22qDS are withdrawn and shy, and have social
impairments which may be less of a concern to the individual.
The Potential Role of CBD in Managing Behavioral
Symptoms Associated with ASD, FXS, and 22qDSThe authors conclude
that preliminary evidence, including findings from the Phase 2
open-label FAB-C study in children and adolescents with FXS and a
retrospective literature review based on insights from that Company
data, shows that CBD improves social anxiety and associated
behavioral manifestations suggesting that it may prove to be
effective in managing the spectrum of behavioral symptoms
associated with these conditions.
About Zynerba Pharmaceuticals,
Inc. Zynerba Pharmaceuticals is the leader in
pharmaceutically-produced transdermal cannabinoid therapies for
rare and near-rare neuropsychiatric disorders. We are committed to
improving the lives of patients and their families living with
severe, chronic health conditions including Fragile X Syndrome,
Autism Spectrum Disorder, 22q11.2 Deletion Syndrome, and a
heterogeneous group of rare and ultra-rare epilepsies known as
developmental and epileptic encephalopathies. Learn more at
www.zynerba.com and follow us on Twitter at
@ZynerbaPharma.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. We may, in some cases, use terms such as
“predicts,” “believes,” “potential,” “proposed,” “continue,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “might,” “will,” “should” or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from the Company’s current
expectations. Management’s expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including the following: the Company’s cash and cash
equivalents may not be sufficient to support its operating plan for
as long as anticipated; the Company’s ability to obtain additional
funding to support its clinical development programs; the results,
cost and timing of the Company’s clinical development programs,
including any delays to such clinical trials relating to enrollment
or site initiation; clinical results for the Company’s product
candidates may not be replicated or continue to occur in additional
trials and may not otherwise support further development in a
specified indication or at all; actions or advice of the U.S. Food
and Drug Administration and foreign regulatory agencies may affect
the design, initiation, timing, continuation and/or progress of
clinical trials or result in the need for additional clinical
trials; the Company’s ability to obtain and maintain regulatory
approval for its product candidates, and the labeling under any
such approval; the Company’s reliance on third parties to assist in
conducting pre-clinical and clinical trials for its product
candidates; delays, interruptions or failures in the manufacture
and supply of the Company’s product candidates the Company’s
ability to commercialize its product candidates; the size and
growth potential of the markets for the Company’s product
candidates, and the Company’s ability to service those markets; the
Company’s ability to develop sales and marketing capabilities,
whether alone or with potential future collaborators; the rate and
degree of market acceptance of the Company’s product candidates;
and the Company’s expectations regarding its ability to obtain and
adequately maintain sufficient intellectual property protection for
its product candidates. This list is not exhaustive and these and
other risks are described in the Company’s periodic reports,
including the annual report on Form 10-K, quarterly reports on Form
10-Q and current reports on Form 8-K, filed with or furnished to
the Securities and Exchange Commission and available
at www.sec.gov. Any forward-looking statements that the
Company makes in this press release speak only as of the date of
this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Investor ContactWilliam Roberts,
Vice President, Investor Relations and Corporate
CommunicationsZynerba Pharmaceuticals484.581.7489
robertsw@zynerba.com
Media contactMolly DevlinEvoke
KYNE215.928.2199Molly.Devlin@evokegroup.com
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Apr 2023 to Apr 2024