Health Canada has granted approval to Edesa Biotech for a Phase II clinical trial of its EB06 monoclonal antibody candidate to treat vitiligo, a life-altering autoimmune disease.
The placebo-controlled, double-blind Phase II trial will assess the efficacy and safety of EB06 against a placebo in moderate to severe non-segmental (generalised) vitiligo adult patients.
It will enrol nearly 120 adult participants at approximately 25 investigational centres in Canada.
In the trial, the participants will receive intravenous infusions of either the antibody or a placebo throughout the treatment period. This will be accompanied by a follow-up period.
Improvement from baseline showed on the Face Vitiligo Area Scoring Index (F-VASI) will be the trial’s primary endpoint.
F-VASI is a quantitative clinical tool that estimates the overall vitiligo patch areas, as well as the degree of macular re-pigmentation in these patches over time.
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Edesa Biotech CEO Par Nijhawan said: “This significant milestone in our vitiligo programme provides us another novel Phase II-ready asset and the opportunity to expand our discussions around partnering and advancing this late-stage biologic asset in our pipeline.
“Despite the high prevalence of vitiligo, there are few effective treatment options and no approved systemic therapeutics targeting the underlying disease.”
EB06 specifically binds to chemokine ligand 10 (CXCL10) and inhibits the CXCL10 interaction with its receptor(s).
The company stated that CXCL10 is highly expressed in both skin and serum in vitiligo patients.
It is implicated in the beginning of the disease, as well as the maintenance of vitiligo lesions.
Data from three previous clinical studies in 65 subjects showed that EB06 produced the pharmacodynamic/biological activity which is required for addressing the dysfunctional immune response that is associated with vitiligo.
The monoclonal antibody candidate was also found to be well tolerated and safe.