Zynerba Pharmaceuticals Presents Two Posters at the Society of Biological Psychiatry 2021 Virtual Meeting
April 29 2021 - 2:00PM
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders, is
presenting two posters at the Society of Biological Psychiatry
(SOBP) 2021 Virtual Meeting. Both posters will be made available on
the Zynerba corporate website at the time of their presentations at
http://zynerba.com/publications/.
The first poster titled, “Cannabidiol in Fragile X Syndrome
(FXS): Proposed Mechanism of Action (MOA) Translates Into
Meaningful Clinical Benefits [CONNECT-FX (ZYN2-CL-016)]” describes
responder thresholds representing individual patient-level changes
that the company believes are indicative of meaningful treatment
benefit for the ABC-CFXS social avoidance, irritability, and
socially unresponsive/lethargic subscales. The authors
concluded:
- Responder thresholds for meaningful
within-patient behavioral change on key domains of the ABC-CFXS
were determined using anchor-based methods based upon FDA guidance
for caregiver-reported outcomes
- The responder thresholds for
meaningful within-patient behavioral change in CONNECT-FX
corresponded to the following reductions
- 3 or more points on the ABC-CFXS
Social Avoidance subscale
- 9 or more points on the ABC-CFXS
Irritability subscale
- 5 or more points on the ABC-CFXS
Socially Unresponsive/Lethargic subscale
- These thresholds serve as a basis
for evaluating clinically meaningful treatment effects at the
individual patient level in clinical trials of children and
adolescents with FXS as demonstrated for Zygel (ZYN2) in
CONNECT-FX
- Zygel provided meaningful
improvements in behavioral symptoms of FXS in patients with ≥90%
methylation of the FMR1 gene.
The poster, with submission ID #3010113, will be presented today
in Poster Session I beginning at 12:15 p.m. CT (1:15 p.m. ET).
“We believe these data demonstrate the ABC-CFXS subscales
capture behaviors that are impactful and meaningful in clinical
trials of children with FXS,” said Joseph M. Palumbo, M.D., LFAPA,
MACPsych, Chief Medical Officer of Zynerba. “Therefore, we remain
confident that these subscales are fit for purpose for measuring
clinical trial endpoints in FXS.”
The second poster titled, “A Pivotal Study of ZYN002 Cannabidiol
(CBD) Transdermal Gel in Children and Adolescents With Fragile X
Syndrome [CONNECT-FX (ZYN2-CL-016)]” will be presented on April 30,
2021 and focuses on the findings in the CONNECT-FX study for the
80% of randomized patients whose FMR1 genes were highly methylated.
This poster, with submission ID #3010130 will be presented tomorrow
in Poster Session II beginning at 12:00 p.m. CT (1:00 p.m. ET).
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
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Zynerba Pharmaceuticals (NASDAQ:ZYNE)
Historical Stock Chart
From Sep 2023 to Sep 2024