AprilBio announced on February 18 that its interleukin-18 (IL-18) inhibitor, APB-R3, has officially entered Phase 2 clinical trials in the United States. Its licensing partner, U.S.-based Evommune, initiated the first patient dosing on February 17 under the local code name EVO301.

The ongoing clinical trial (NCT06723405) aims to evaluate the safety and efficacy of APB-R3 in approximately 60 patients with moderate-to-severe atopic dermatitis. Over a 12-week treatment period, the study will use the Eczema Area and Severity Index (EASI) score as a primary endpoint to assess therapeutic efficacy.

APB-R3 is a novel drug candidate that treats autoimmune inflammatory diseases by inhibiting IL-18 activity. It was developed using AprilBio’s proprietary SAFA (Sustained Antibody Fc-fusion Approach) platform, designed to enhance drug stability and prolong half-life. 

Evommune acquired the global development rights to APB-R3 in a licensing deal worth approximately KRW 660 billion (~$500 million) in June 2023.

J. Mark Jackson, Vice President of Evommune, stated, “The demand for more potent treatments in the atopic dermatitis market continues to grow. APB-R3 has the potential to provide a new therapeutic option for patients who do not respond to currently available treatments.”

An AprilBio representative added, “With the SAFA platform proving its safety and extended half-life, our pipeline is now entering the critical stage of validating therapeutic efficacy. Alongside our thyroid eye disease (TED) treatment APB-A1, the smooth progress of APB-R3’s clinical trials is expected to further enhance the value of our pipeline.”