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 evaluating the Social Avoidance,
Irritability, and Socially Unresponsive/Lethargic subscales of the
Aberrant Behavior Checklist Community: FXS Specific (ABC-CFXS) in
relation to the experience of caregivers caring for a child with
Fragile X syndrome. The poster describes data collected via
web-based journals and in-depth interviews of caregivers of
children with Fragile X syndrome (FXS). The data indicate that nine
of ten caregivers reported their children had behaviors
representative of social avoidance, socially
unresponsiveness/lethargic, and irritability and the behaviors
described had strong concordance with individual items of the
ABC-CFXS.
The poster, entitled Content Validity of the ABC-CFXS and
Subscales in Fragile X 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/.
Terri Browning Sebree, Zynerba’s President, is presenting data
providing qualitative evidence of the appropriateness of Social
Avoidance, Irritability, and Socially Unresponsive/Lethargic
subscales of the ABC-CFXS in assessing core symptoms of FXS. In
addition, the data further validate social avoidance, irritability,
and socially unresponsive/lethargic behaviors as core FXS
behavioral symptoms from the perspective of caregivers of children
with the disorder. The Company is utilizing the ABC-CFXS to assess
improvements in core behaviors of FXS in the ongoing 14-week
pivotal CONNECT-FX study of Zygel™ (CBD gel). Ms. Sebree will
present the poster from 12:40 to 1:45 British Summer Time (BST) on
September 5th and 6th, 2019.
“Fragile X syndrome is a complex diagnosis for a child and
his/her family, marked by a myriad of specific behavioral and
emotional symptoms often manifesting as anxiety and social avoidant
behaviors,” said Ms. Sebree. “Through studies like this one, we are
able to not only elucidate the most common core behaviors of FXS,
but also further validate the appropriateness of the ABC-CFXS as an
effective tool for use in clinical studies as a means to measure
improvements in these core and common FXS behaviors.”
Ten caregivers of children formally diagnosed with FXS
participated in this study with assistance from the National
Fragile X Foundation (NFXF) via online invitation through the NFXF
website. The study found that 90% of caregivers reported at least
one behavior that was representative of social avoidance, socially
unresponsive/lethargic, and irritability
Social Avoidance
It was common for their children with FXS to prefer the company
of single family members to groups of people, even friends, and to
seek isolation from others either via physical setting (staying in
their room or in the car) or blocking out the world (using
headphones). Social avoidance had a negative impact on important
activities, such as travel, schooling, or visits to the doctor.
The social-avoidant behaviors reported by caregivers, including
‘seeks isolation from others’, ‘prefers to be alone’, and ‘prefers
solitary activities’ corresponded to items on the Social Avoidance
subscale, including seeks isolation from others and isolates
himself/herself from other children or adults
Irritability
Irritability was associated with a broad spectrum of verbal
(talking back, hollering, articulate yelling, non-verbal screams)
and physical behaviors (hitting siblings, overturning furniture) at
inappropriate times.
Frequently reported aspects of misbehavior and irritability
mapped onto items of the Irritability subscale, specifically
‘aggressive to others’, ‘irritability’, ‘temper
tantrums/outbursts’, ‘screaming/yelling inappropriately’, ‘harming
of others’, and ‘stubbornness’.
Socially Unresponsive/Lethargic
Caregivers frequently reported of ‘lack of interaction’ and
‘lack of attention’ in their children with FXS, which mapped to
subscale items such as ‘preoccupied’, ‘stares into space’,
‘unresponsive to structured activities (does not react)’, and
‘shows few social reactions to others’. Items on the subscale
pertaining to communication were identified as important by
caregivers, particularly with respect to how they may exacerbate
other syndrome-related behaviors.
The authors conclude that these data further validate social
avoidance, irritability, and socially unresponsive/lethargic as
core phenotypic behaviors of children with FXS and show that
caregiver experiences correspond with ABC-CFXS subscales, further
validating the appropriateness of the ABC-CFXS as an effective
assessment tool in clinical trials.
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,”
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“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
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conducting pre-clinical and clinical trials for its product
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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
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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
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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
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