TWi Biotechnology (TWiB) has completed patient enrolment in a Phase II clinical trial of AC-203 for the treatment of inherited epidermolysis bullosa (EB).
EB is a genetic skin disease characterised by skin fragility and repeated blister formation.
AC-203 is a topical formulation that contains 1% diacerein. It has the potential to mechanistically inhibit NLRP3 inflammasome activation.
TWiB intends to assess the efficacy, safety and tolerability of AC-203 in different EB sub-types such as epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB).
The multi-centre, double-blind, proof-of-concept trial has enrolled nine subjects.
Subjects have been randomised at two sites in Hsinchu and Tainan in Taiwan.
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They will undergo once daily topical treatment of AC-203 in two designated lesion areas for eight weeks, followed by four weeks of follow-up period without any treatment.
In order to assess efficacy, the trial is expected to measure the change of lesion surface areas in blisters, erythema, erosion and crust within the selected lesion areas from baseline.
The placebo-control, intra-individual comparison study will also evaluate safety, pruritus and pain scale, levels of pro-inflammatory cytokines, as well as daily digital skin images of lesions taken by patients.
Top-line results from the AC-203-EBS-005 trial are expected to be available in the second quarter of this year.
TWi Biotechnology CEO Calvin Chen said: “EB is a debilitating skin disease without any effective or FDA-approved treatment. Some EB sub-types could be lethal and patients are more at risk for developing squamous cell carcinoma.
“It is a huge burden for the patients and families.”
Results from the trial are also set to help support TWIB’s global development partner, Castle Creek Pharma (CCP), to extend the research across the US and European Union (EU).