Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE), the leader in 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.
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 poster was presented today (April 29).
Zynerba said 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 US Food and Drug Administration 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; and 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.
“We believe these data demonstrate the ABC-CFXS subscales capture behaviors that are impactful and meaningful in clinical trials of children with FXS,” said Dr Joseph M. Palumbo, chief medical officer of Zynerba, in a statement. “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 and focuses on the findings in the CONNECT-FX study for the 80% of randomized patients whose FMR1 genes were highly methylated.
This poster will be presented in Poster Session II beginning at 1 pm ET.
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