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Aquinox begins Phase II trial of AQX-1125 to treat atopic dermatitis

Canada-based Aquinox Pharmaceuticals has started a Phase II clinical trial (KINSHIP) of its lead drug candidate AQX-1125 to treat patients with atopic dermatitis (AD).

AQX-1125 is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway.

The randomized, double-blind, multicenter, placebo-controlled Phase II KINSHIP trial is being conducted at clinical research centers in Canada.

The trial is designed to evaluate the efficacy and safety of AQX-1125 in about 50 adult patients with mild to moderate AD.

Primary endpoint of the trial is change from baseline in Total Lesion Symptom Score (TLSS) after 12 weeks of treatment.

The company said that TLSS is a comprehensive assessment of AD symptoms where AQX-1125 may have a beneficial effect.

The trial’s secondary endpoints include safety, pharmacokinetics and additional parameters for evaluating AD.

Aquinox senior vice-president of Clinical Development and chief medical officer Dr Stephen Shrewsbury said: "We believe AQX-1125’s ease of administration as a once daily, oral, anti-inflammatory medicine, and its ability to reduce immune cell migration to inflamed surfaces, could provide a clinically meaningful benefit to AD patients.

"The KINSHIP trial has been designed to first evaluate AQX-1125’s safety and efficacy in mild to moderate AD patients. Our eventual interest is AQX-1125’s potential as an effective, oral therapy for moderate to severe AD patients."

The company said that by increasing SHIP1 activity, AQX-1125 accelerates a natural mechanism that has evolved to maintain homeostasis of the immune system and reduce immune cell activation and migration.

In multiple preclinical studies and clinical trials, AQX-1125 has showed preliminary safety and favorable drug properties.

Currently, the company is exploring AQX-1125 as a once-daily oral treatment in several Phase II trials.