TWi Biotechnology (TWiB) announced that they have received Clinical Trial 
Application (CTA) approval from the Health Canada to conduct a Phase 1 clinical 
trial with AC-1101 gel. AC-1101 is a topical JAK inhibitor for the potential 
treatment of patients with vitiligo. Currently, there are no U.S. Food and Drug 
Administration (FDA) or European Medicines Agency (EMA)-approved drug therapies 
for the treatment of vitiligo.

The AC-1101 Phase 1 trial is an open-label, fixed-sequence, two-period, 
comparative bioavailability study of AC-1101 from repeated topical applications 
of AC-1101 gel to single oral administration of its oral reference product in 
healthy adult volunteers in Canada and is expected to be completed at the end 
of 2020.

AC-1101 is a repurposing product for topical treatment of inflammatory skin 
diseases including vitiligo. The purpose of this first clinical trial is to 
bridge the pharmacokinetics and safety of our unique topical product with the 
marketed oral product. The Phase 1 study results will support to advance 
AC-1101 to the next Phase 2 dose ranging clinical trial and regulatory 
milestones.

About AC-1101 gel

AC-1101 gel is a topical formulation of a FDA approved-oral JAK inhibitor. 
AC-1101 gel is developed to treat a wide variety of inflammatory skin diseases 
such as atopic dermatitis and vitiligo.

About TWi Biotechnology 

TWi Biotechnology, Inc. is a Taiwan-based clinical stage biopharmaceutical 
company specializing in the development of new drugs for unmet medical needs, 
especially in diseases associated with innate immunity. The company is building 
its product pipeline through in-licensing and internal research. Its product 
development pipeline includes three drug candidates for treating patients with 
epidermolysis bullosa simplex, EGFR inhibitor-related skin rash and vitiligo.

For more detailed information, please visit the website at: 
https://www.twibiotech.com/website

SOURCE TWi Biotechnology, Inc.