MALVERN, PA – May 31, 2017 – Ralexar Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of topical and systemic therapies based on Liver X Receptor (LXR) modulators, announced today that patient enrollment has begun in a Phase 2b clinical study evaluating ALX-101 topical gel as a potential treatment for atopic dermatitis. The clinical study will be conducted at approximately 30 centers across the United States.
“We are pleased that enrollment has begun in this study, which represents an important next step toward our goal of delivering a novel therapy to patients,” said Dave Pfeiffer, President and Chief Executive Officer, Ralexar Therapeutics. “There remains a significant unmet need for new non-steroidal topical agents to improve the treatment alternatives for patients suffering from atopic dermatitis.”
The multicenter, randomized, double-blind, vehicle-controlled Phase 2b study will enroll adults and adolescents with moderate atopic dermatitis. Two concentrations of ALX-101 will be tested (ALX-101 Gel 1.5% & ALX-101 Gel 5%) along with placebo gel. Gel will be applied topically twice daily for six weeks. The primary objective of the study is to evaluate the mean change in Physician’s Global Assessment score from baseline to day 43.
ALX-101 topical gel is a novel and potent LXR agonist developed by Ralexar Therapeutics, Inc. that is specifically designed to have pharmacological activity targeted to the skin with minimal systemic absorption. 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.
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.
Ralexar 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.ralexartx.com.
Mike Beyer, Sam Brown, Inc.