April 2024
News
GM-XANTHO Phase 2a Clinical Progress
GM-XANTHO is a botanical new drug for treating atopic dermatitis (AD) and the patient enrollment progress of the phase 2a clinical trial (NCT04369846) has reached 80%. It is expected that the patient recruitment will be completed at the end of 2024, and the unblinded clinical data and clinical statistical analysis will be available in the first half of 2025.
GM-XANTHO is a topical drug for modulating the imbalance of the immune system in atopic dermatitis. The drug also contributes to the repair of skin barrier defects, achieving a comprehensive therapeutic effect. GM-XANTHO is now being studied in a USFDA and Taiwan FDA approved, multi-center, randomized, placebo-controlled phase 2a clinical trial, to evaluate the efficacy and safety profiles of GM-XANTHO in the treatment of atopic dermatitis.The study includes the well-recognized clinical endpoints for AD, the IGA (Investigator Global Assessment), EASI, and SCORAD scores, to evaluate AD severity and BSA of AD involvement. Mild-to-moderate AD patients (with IGA 2 and 3) at the baseline are recruited in the study. Following the completion of phase I study in 2021 Feb at NTUH, the phase 2a study was initiated in April 2021. To speed up the recruiting process, the study has become a multi-center study in 2023, by collaborating with study teams at new sites including TMUH (2023 Jul.), SHH (2023 Aug.) CGMH-LK (2023 Dec.).
