PR83949

TAIPEI, Taiwan, May 7, 2020 /PRNewswire＝KYODO JBN/ --

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.