The Patient Enrollment Progress of Phase 2a Clinical Trial of GM-XANTHO has reached 80 %
GM-XANTHO is a botanical drug for treating atopic dermatitis (AD) and the progress of the patient enrollment of its phase 2a clinical trial (NCT04369846) has reached 80%. It is expected that the patient recruitment process 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 balance 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 in addition to NTUH, the study has become a multi-center study in 2023, by collaborating with study teams at the following new sites, TMUH (2023 Jul.), SHH (2023 Aug.), and CGMH-LK (2023 Dec.).
The Market of Botanical new drug for Atopic dermatitis
Recent studies have shown that the global prevalence rate for atopic dermatitis (AD) has been increasing, with the highest prevalence rate of up to 15%-20% in children, and prevalence rate of 1%-3% in adults. AD is a recurring immune disease and a novel medication with less side effects which is safe for long term use for AD treatment is needed to overcome the relapsing scenarios of the disease.
To resolve the difficulties faced in AD treatment, Xantho Bio. is dedicated to the development of botanical new drug for the treatment of AD, GM-XANTHO. The drug is anticipated to become an alternative for steroids with serious side effects and costly biologics, serving as a new option for doctors and AD patients in the future.
The botanical extracts which are mixtures can have multiple clinical effects in treating diseases. Botanical extracts have lower side effects in clinical applications as usually the safety profile of their natural sources have been proven in the long history of human use experience in traditional medicine. There has been a growing attention to such medications in modern-day drug development, providing opportunities for developing novel therapies with improved clinical effectiveness and safety profile.
Xantho Bio. is dedicated to the development of botanical new drugs suitable for long term use with low side effects, focusing on the regulation of immunity and the repair of the skin barrier defects. Currently, the GM-XANTHO has entered phase 2 clinical trial for AD. In addition, the drug has shown potential in the treatment of other immune diseases in dermatology and wound healing, which may reduce treatment cost significantly, solving a major issue in therapies now available.
Disclaimer
This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change.