The posters spotlight the corporate’s progress with Zygel, a CBD-based gel to be used as a remedy for Fragile X Syndrome
Inc (), the chief in pharmaceutically-produced transdermal cannabinoid therapies for uncommon and near-rare neuropsychiatric issues, is presenting two posters on the Society of Biological Psychiatry (SOBP) 2021 Virtual Meeting.
Both posters will probably be made obtainable 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 particular person patient-level modifications that the corporate believes are indicative of significant remedy profit for the ABC-CFXS social avoidance, irritability, and socially unresponsive/torpid subscales. The poster was introduced in the present day (April 29).
Zynerba mentioned the authors concluded:
- Responder thresholds for significant within-patient behavioral change on key domains of the ABC-CFXS had been decided utilizing anchor-based strategies based mostly upon US Food and Drug Administration steering for caregiver-reported outcomes.
- The responder thresholds for significant within-patient behavioral change in CONNECT-FX corresponded to the next reductions: 3 or extra factors on the ABC-CFXS Social Avoidance subscale; 9 or extra factors on the ABC-CFXS Irritability subscale; and 5 or extra factors on the ABC-CFXS Socially Unresponsive/Lethargic subscale.
- These thresholds function a foundation for evaluating clinically significant remedy results on the particular person affected person degree in medical trials of youngsters and adolescents with FXS as demonstrated for Zygel (ZYN2) in CONNECT-FX.
- Zygel offered significant enhancements in behavioral signs of FXS in sufferers 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,” mentioned Dr Joseph M. Palumbo, chief medical officer of Zynerba, in an announcement. “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 probably be introduced on April 30 and focuses on the findings within the CONNECT-FX research for the 80% of randomized sufferers whose FMR1 genes had been extremely methylated.
This poster will probably be introduced in Poster Session II starting at 1 pm ET.
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