The Company previously announced that it is planning to conduct a Phase II clinical trial spearheaded by principal investigator, Dr.
The primary objective of the clinical trial is to evaluate the efficacy, safety and tolerability of GCANRx’s proprietary therapeutic in pediatric patients (between 4 and 13 years of age) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either GCANRx’s therapeutic or a matched placebo. The primary efficacy objective of the study will be to assess the effect of the neuroprotective therapeutic compared to placebo on behavioral problems, using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I) score - change from baseline to week 12. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for therapeutic and placebo groups. The main secondary objective is to assess the effect of the neuroprotective therapeutic compared to placebo on the core ASD symptoms using the Vineland TM Adaptive Behavior Scales (3rd edition, VABS3)- 2-Domain Composite Score, and Social Responsiveness Scale 2nd edition (SRS-II) total score - change from baseline to week 12. The study, which will be conducted in
ASD is a life long condition with no cure that affects 7 million people in the US (about 5.4 million adults), and over 75 million people globally. Current pharmaceutical therapies are only minimally effective and have significant side effect profiles including obesity and altered hormone production. The cost of caring for autistic Americans reached
“We are excited to announce that GCANRx has received a final official approval to embark on its Phase II Clinical Trial for our therapeutic aimed at treating ASD and other neuropsychiatric disorders. This significant milestone marks another pivotal moment in our path to develop innovative therapeutic solutions for patients suffering from complex neurological disorders”, said
ENDS
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