Atopic Dermatitis

LXR Program Overview

Vitae Pharmaceuticals is developing VTP-38543 as a topical treatment for eczema, or atopic dermatitis. VTP-38543 is a Liver X Receptor (LXR) selective agonist. VTP 38543 is expected to improve barrier function and decrease inflammation, in this case in damaged skin tissue. VTP-38543 works by decreasing inflammation in damaged skin tissue and repairing the damaged outer layer of skin by forming new cells and cementing the new cells together with secreted lipids.

VTP-38543 is different from other atopic dermatitis drugs commonly used which have already been approved. In addition to decreasing inflammation, VTP-38543 repairs the outer layer of skin, improving the barrier function. In preclinical studies, VTP-38543 proved to be a novel approach with the potential to demonstrate clinical superiority to existing therapy. VTP-38543 is currently in a Phase 2a proof-of-concept clinical trial assessing the safety, tolerability and efficacy of VTP-38543 in patients with mild to moderate atopic dermatitis. We anticipate clinical trial results in the fourth quarter of 2016.

About Atopic Dermatitis

Atopic dermatitis, also known as eczema, is a common inflammatory skin disease characterized by a loss of barrier function of the skin and skin inflammation. The National Eczema Association reports that there are approximately 31.6 million people in the United States with symptoms of atopic dermatitis. The National Institute of Arthritis and Musculoskeletal and Skin Diseases estimates that the prevalence of infant and children atopic dermatitis in the United States is approximately 7-17%.

Activation of LXR in skin keratinocytes, or the most common cell type in the outermost layer of “normal” skin, plays an important role in maintaining skin function. LXR activity is critical for maintaining the impermeable barrier of skin. LXR activation also has an anti-inflammatory effect in skin.

Vitae Pharmaceuticals believes LXR agonists’ ability to both improve skin inflammation and improve the barrier function of the skin is unique.

The two most commonly used classes of topical therapies for atopic dermatitis are glucocorticoids and calcineurin inhibitors. Though effective, they both have been shown to have serious side effects in some patients. Vitae Pharmaceuticals believes there is a significant opportunity to develop a new therapy for eczema that may be effective with a better safety profile.

Vitae Pharmaceuticals is advancing its wholly-owned atopic dermatitis drug, VTP-38543, through clinical trials

Vitae Pharmaceuticals believes VTP-38543 can be developed as an effective therapy that controls inflammation and improves the skin barrier function in atopic dermatitis patients while avoiding the side effects associated with existing treatments.

VTP-38543 has been shown to increase LXR activity and decrease skin inflammation in an in vivo mouse model of skin inflammation. In this model, VTP-38543 demonstrated equal or superior efficacy versus a high potency topical corticosteroid, the current standard of care for the treatment of atopic dermatitis.

VTP-38543 is in a phase 2a proof-of-concept trail assessing the safety, tolerability and efficacy of VTP-38543 in patients with mild to moderate atopic dermatitis. We anticipate topline clinical trial results in 4Q 2016.

Read more about Vitae Pharmaceuticals’ Pipeline.