Aquinox Pharmaceuticals, Inc. (Aquinox), a clinical-stage pharmaceutical company, has initiated dosing in a phase 2 clinical trial of AQX-1125 for the treatment of atopic dermatitis (AD).
The KINSHIP clinical 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 KINSHIP trial's primary endpoint 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.
"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," said Dr. Stephen Shrewsbury, senior vice president of clinical development and chief medical officer of Aquinox. "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 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.
AQX-1125, Aquinox's lead drug candidate, is a small molecule activator of SHIP1, which is a regulating component of the PI3K cellular signaling pathway. 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. AQX-1125 has demonstrated preliminary safety and favorable drug properties in multiple preclinical studies and clinical trials. Aquinox is currently exploring AQX-1125 as a once-daily oral treatment in several phase 2 trials.
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology.