TWi Biotechnology has enrolled patients in its Phase 2 clinical trial of AC-203 for the treatment of inherited Epidermolysis Bullosa (EB).
The treatment will include Epidermolysis Bullosa Simplex (EBS), Dystrophic Epidermolysis Bullosa (DEB) and Junctional Epidermolysis Bullosa (JEB).
The company said in the press release that the Phase 2 clinical trial is the first multi-center, double-blind, randomized, placebo-control, intra-individual comparison study conducted to evaluate the efficacy, safety and tolerability of AC-203 in different EB sub-types. Launched in October 2018, enrollment was completed within 3 months with 9 subjects randomized at 2 sites in Hsinchu and Tainan. The company expects to report top-line results in second quarter of 2019. The trial results will help support TWIB’s global development partner, Castle Creek Pharma (CCP), to extend the indication in both US and EU.
Calvin Chen, Chief Executive Officer of TWiB said that EB doesn’t ahve any effective or FDA-approved treatment. He said that completing patient enrollment for AC-203-EBS-005 at such a short time is an important milestone for TWiB.