Arcutis Announces First Patient Enrolled in Phase 2a Clinical Trial Evaluating ARQ-252 as a Potential Treatment for Vitiligo - Seite 2

Arcutis is also developing ARQ-252 0.3% cream as a potential treatment for chronic hand eczema and expects to report topline data from a Phase 1/2b study in mid-2021. In October 2020, Arcutis announced that enrollment had been completed in this Phase 1/2b study to assess the safety and efficacy of ARQ-252 0.1% cream once daily and ARQ-252 0.3% cream once daily or twice daily versus vehicle applied once daily or twice daily for 12 weeks to patients with chronic hand eczema.

About Vitiligo
Vitiligo is an auto-immune condition that occurs in as much as 1% of the U.S. population and is characterized by the loss of natural skin color or discolored patches on various parts of the body, including hair and mucous membranes. The cause of vitiligo is unknown but results when the skin’s pigment producing cells (melanocytes) are targeted by the body’s immune system. Vitiligo often starts on the hands, feet, or face and is typically progressive. It is a skin disease that affects people of all skin types but may be more noticeable in people with darker skin. Because of the effect on the person’s appearance, vitiligo can be life-altering and can have a substantial negative impact on the psychological well-being of patients and reduce quality of life. Vitiligo can lead to a poor body image, causing individuals to feel embarrassed or anxious about their skin and withdraw from social activities.

About ARQ-252
ARQ-252 is a potent and highly selective topical, small molecule inhibitor of Janus kinase type 1 (JAK1). Many inflammatory cytokines and other signaling molecules rely on the JAK pathway, and specifically JAK1, which plays a central role in immune system function. Inhibition of JAK1 has been shown to treat a range of inflammatory diseases, including rheumatoid arthritis, Crohn’s disease, and atopic dermatitis. The Company believes that due to its high selectivity for JAK1 over JAK2, ARQ-252 has the potential to effectively treat inflammatory diseases without causing the hematopoietic adverse effects typically associated with JAK2 inhibition. In 2018, Arcutis exclusively licensed the active pharmaceutical ingredient in ARQ-252 for all topical dermatological uses in the United States, Europe, Japan and Canada from Jiangsu Hengrui Medicine Co., Ltd. of China. In mid-2019, Hengrui completed a Phase 2b study in rheumatoid arthritis that used the same active pharmaceutical ingredient as in ARQ-252 but dosed orally. The results confirmed that this active pharmaceutical ingredient is a highly potent inhibitor of JAK1 based on the drug’s impact on rheumatoid arthritis, and was generally well tolerated at exposures well above those expected with topical administration of ARQ-252 in patients with chronic hand eczema. In 2020, Reistone Biopharma, a subsidiary of Hengrui, announced positive topline results from a Phase 2 clinical trial evaluating the oral version of the active ingredient in ARQ-252 for the treatment of moderate-to-severe atopic dermatitis. Reistone Biopharma is also studying the oral formulation as a potential treatment for alopecia areata, Crohn’s disease, and ulcerative colitis.