Arcutis To Terminate Phase 2a Clinical Trial Evaluating ARQ-252 Cream To Treat Vitiligo

Arcutis Biotherapeutics, Inc. (ARQT), a medical dermatology company, announced Thursday its decision to terminate the recently initiated Phase 2a clinical trial evaluating ARQ-252 cream as a potential treatment for vitiligo (ARQ-252-213).

ARQ-252 is a topical small molecule inhibitor of Janus kinase type 1 or JAK1.

The company noted that the vitiligo study is not being terminated for any safety or tolerability reasons. ARQ-252 has been safe and well-tolerated, and no unexpected safety concerns have been identified.

Arcutis' decision is based on further analyses of the ARQ-252 drug formulation used in both this vitiligo study and the recently completed Phase 2b study evaluating ARQ-252 for the treatment of chronic hand eczema (ARQ-252-205).

The company's Phase 2b chronic hand eczema study did not meet its primary endpoint, with none of the ARQ-252 arms achieving statistical significance versus vehicle. Further analyses of that study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy.

Patrick Burnett, Chief Medical Officer of Arcutis, said, "While we are disappointed to terminate this vitiligo study, we believe topical JAK inhibition remains a promising strategy for the treatment of both chronic hand eczema and vitiligo, and that ARQ-252 has potential as a new treatment for both diseases. Published clinical data for other topical JAK inhibitors have shown encouraging results in both indications."

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.

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