2020-05/04
TWi Biotechnology
Receives Canada Health Approval for AC-1101 Phase 1 CTA
Taipei, Taiwan, May
4th, 2020 -- TWi Biotechnology (TWiB) announced today 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
Company contact:
Mr. Weishu Lu, Vice
President, Product Development
+886-2-26571788 # 300
Weishu.lu@twibiotech.com
