Alexar Therapeutics Initiates Phase IIa Clinical Trial For ALX-101 Topical Gel

Study to Assess Novel Liver X Receptor (LXR) Agonist for the Treatment of Patients with Atopic Dermatitis

MALVERN, Pa.--(BUSINESS WIRE)--Alexar Therapeutics, Inc., a privately held specialty pharmaceutical company dedicated to the development of topical and systemic therapies based on Liver X Receptor (LXR) modulators, today announced the initiation of a Phase IIa clinical trial for its novel LXR agonist ALX-101.

“This important study is the first step in understanding the potential clinical effects of ALX-101 gel in patients with atopic dermatitis”

This trial is designed to evaluate the safety, tolerability, dose-response and pharmacokinetics of two concentrations of ALX-101 gel compared with its vehicle (placebo). Seventy-two adult subjects with mild to moderate atopic dermatitis will be randomized into this double-blind, placebo-controlled trial across six investigational centers within the United States.

“This important study is the first step in understanding the potential clinical effects of ALX-101 gel in patients with atopic dermatitis,” said Dave Pfeiffer, President and Chief Executive Officer of Alexar. “We are excited about gaining a greater understanding of this novel approach for treating atopic dermatitis, and this trial will provide a preliminary assessment of safety and efficacy of ALX-101.”

About ALX-101 Topical Gel

ALX-101 topical gel is a novel and potent LXR agonist developed by Alexar Therapeutics, Inc. and is specifically designed to have its pharmacologic activity limited to the skin. LXR agonists are well established as primary regulators of skin barrier function and cutaneous inflammation. Disordered skin barrier function and an abnormal inflammatory response are the primary etiopathologic mechanisms of atopic dermatitis. ALX-101 topical gel is currently being evaluated to determine if it may reduce or treat the clinical manifestations of atopic dermatitis.

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic, relapsing, inflammatory disease of the skin resulting from a complex interaction of genetic and environmental factors that eventuates in skin barrier dysfunction and a dysregulation of immune responses. Clinical manifestations include areas of pruritus (itching), skin lesions, inflammation and loss of skin integrity.

The prevalence of AD in the United States ranges from 10 to 20 percent in children and approximately 1 to 3 percent in adults. A topical treatment with the potential to relieve the clinical manifestations of AD with a decreased risk of systemic effects would be an important advancement in the treatment of this common skin condition.

About Alexar Therapeutics, Inc.

Alexar Therapeutics, Inc. is a privately held specialty pharmaceutical company founded in January 2014 and based in Malvern, Pennsylvania. The company is developing topical and systemic therapies based on LXR modulators. The initial focus for the company is on developing ALX-101 for the treatment of various cutaneous inflammatory disorders. More information can be found by visiting the company’s website at www.alexartx.com.