Zynerba Pharmaceuticals Presents Sleep Data from Study of Zygel™ in Children and Adolescents with Both Developmental and Ep...
June 11 2021 - 12:30PM
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders,
presented a poster today at SLEEP 2021, the 35th Annual Meeting of
the Associated Professional Sleep Societies, LLC. A copy of the
poster is available on the Zynerba corporate website at
http://zynerba.com/publications/.
The poster titled “Impact of ZYN002 Cannabidiol Transdermal Gel
on Sleep in Children and Adolescents with Developmental and
Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder,”
shows that in an open-label Phase 2 trial with patients with
developmental and epileptic encephalopathies (DEE), treatment with
Zygel™ was associated with improved sleep in children with
clinically significant sleep disorders at baseline. Furthermore,
the children with both DEE and autism spectrum disorder (ASD)
showed more wide-ranging benefits on sleep compared to those with
DEE alone.
“Epilepsy and sleep disorders have a bidirectional relationship
and co-occur in individuals with ASD. Improvements in sleep may
result in better seizure control and behavior in these medically
fragile children with DEE,” said Joseph M. Palumbo, M.D., LFAPA,
MACPsych, Chief Medical Officer of Zynerba. “While these results
are exploratory in nature, they are encouraging and warrant
confirmation in future clinical trials of Zygel in patients with
DEE and/or ASD.”
In the open-label Phase 2 trial with Zygel in patients with DEEs
aged 3 to ≤17 years, improvements were observed in different
aspects of sleep in the two groups. In patients with ASD (n=5),
improvements compared to baseline were observed over the 26-week
study period in sleep breathing (p=0.018), sleep wake transition
(p=0.006) and the total sleep disturbance scale for children
(p=0.024). In patients without ASD (n=11), improvement was seen in
initiating and maintaining sleep (p=0.033). Zygel was well
tolerated in the trial. Most treatment-emergent adverse events were
characterized as mild or moderate. Over the 26-week study period,
60.4% participants had ≥1 related adverse event, with 93%
mild/moderate severity.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative
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 expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
incentive and other tax credit eligibility, collectability and
timing, and availability of and the need for additional financing;
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; the Company’s expectations regarding its ability to
obtain and adequately maintain sufficient intellectual property
protection for its product candidates; the timing and outcome of
current and future legal proceedings; and the extent to which
health epidemics and other outbreaks of communicable diseases,
including COVID-19, could disrupt our operations or adversely
affect our business and financial conditions. 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 Contact
Peter VozzoWestwicke/ ICROffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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