Zynerba Pharmaceuticals Inc. (NASDAQ:ZYNE) has announced the launch of the second phase of its INSPIRE trial evaluating the company’s lead candidate Zygel which is a transdermal cannabidiol gel that treats emotional and behavioral symptoms of 22q11.2 deletion symptoms.
22q11.2 deletion condition is an inherited pediatric condition whose symptoms range from mild behavioral issues to psychological and physical abnormalities such as cleft palate, speech development issues, immune issues, and heart problems. The disorder results from the defects on chromosome 22 which can lead to defects on the body system.
Zygel, which was previously referred to as ZYN002, is a non-psychoactive cannabinoid that is created as a permeation gel for skin delivery. The INSPIRE trial will evaluate the safety, potency, and tolerability of Zygel for treatment of 22q11.2 deletion syndrome symptoms. The company expects to release top-line data from the study in the first half of next year.
The INSPIRE trial will run for fourteen weeks and it is an open label multi-dose clinical trial that will evaluate the safety and potency of the gel in 20 children with 22q. Subjects will be dosed with 250mg or 500mg of Zygel daily.
Chairman and CEO of Zynerba Armando Anido said that children with genetically confirmed disease usually need surgeries to correct the acute defects such as palate and heart abnormalities and once they have been corrected they develop various behavioral symptoms that need to be managed. Parents of children with 22q report considerable rates of withdrawal behaviors, pervasive development challenges, affective disorders and anxiety in the children.
The CEO stated that there is a possibility of such patients developing psychoses like Schizophrenia in later stages of life. Armando added that they were glad to launch the INSPIRE trial to assess the effectiveness of Zygel in the management of the symptoms in these children and adolescents.
The efficacy assessments of the gel will include the Columbia Suicide Severity Rating Scale (C-SSRS), Aberrant Behaviour Checklist-Community (ABC-C), Depression and Mood Scale (ADAMS) the Anxiety, Clinical Global Impression-Severity and Improvement, and the Qualitative Caregiver Reported Behavioural Problem Survey.
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