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DEVON, Pa., April 29, 2021 (GLOBE NEWSWIRE) -- 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.
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