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news.Canada-based Aquinox Pharmaceuticals has completed patient enrolment in the Phase II KINSHIP trial of its lead drug candidate, AQX-1125, to treat atopic dermatitis.
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AQX-1125 is a small molecule activator of SHIP1 suitable for oral, once daily dosing and it has been evaluated in multiple preclinical studies and clinical trials.
The randomized, double-blind, multicenter, placebo-controlled KINSHIP trial is being conducted at sites in Canada to evaluate the efficacy and safety of AQX-1125 in about 50 adult patients with mild to moderate atopic dermatitis as a proof-of-concept trial in this indication.
Aquinox president and CEO David Main said: "We are pleased with how enrollment has proceeded in this Phase II clinical trial.
"Our non-clinical studies have led us to a potential link between skin inflammation and SHIP1 and we believe that the mechanism of action and properties of AQX-1125, as a once daily, oral, anti-inflammatory treatment, may provide a benefit to patients with atopic dermatitis."
Primary endpoint of the trial is change from baseline in Total Lesion Symptom Score after 12 weeks of treatment, while secondary endpoints include safety, pharmacokinetics and additional efficacy endpoints, including the analyses of biopsies.
The company intends to report top line data from the KINSHIP trial in the first quarter of 2016.