Atopic Dermatitis (AD), often referred to as atopic eczema or just eczema, is an uncomfortable, relapsing, non-contagious, inflammatory skin disorder that is typically characterized by dry, itchy skin and is frequently associated with other allergic disorders, especially asthma and hay fever. AD symptoms manifest as redness, scaling, and loss of the surface of the skin with lesions that have a tendency to weep, crack, swell or crust-over and are at heightened risk for infection. AD has been traced to a defect of the immune system within the skin but the cause of the disease is largely unknown, although a genetic component is well recognized.
The prevalence of AD ranges from 1%-20% worldwide. An estimated 17.8 million Americans are affected by AD, which is considered underdiagnosed by physicians. Approximately two-thirds of Americans with AD suffer from the moderate to severe form of the disease, where existing therapies are often ineffective or unsuitable for long-term treatment. In preclinical studies where SHIP1 was not present, dermatitis-like symptoms were observed.
Our Phase 2 clinical trial, known as the KINSHIP trial, is being conducted at clinical research centers in Canada as a randomized, double-blind, multicenter, placebo-controlled Phase 2 trial evaluating the efficacy and safety of AQX-1125 in approximately 50 adult patients with mild to moderate AD. The primary endpoint of the KINSHIP trial is change from baseline in Total Lesion Symptom Score (TLSS) after 12 weeks of treatment. The TLSS is a comprehensive assessment of AD symptoms where AQX-1125 may have a beneficial effect. Secondary endpoints include safety, pharmacokinetics and additional parameters for assessing AD.
Given our observation of dermatitis symptoms in preclinical studies where SHIP1 was absent, as well as AQX-1125’s demonstrated activity against diseases with a similar etiology (eg. asthma), we believe that SHIP1 activation with AQX-1125 has the potential to reduce inflammation at dermal surfaces and provide a meaningful benefit to patients suffering from AD.