JW Jungwoo's 'Technology Export' Atopy New Drug Candidate Enters Global Phase 2b Clinical Trial

JW Pharmaceutical's atopic dermatitis drug candidate 'JW1601' (Photo by JW Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] JW Pharmaceutical's atopic dermatitis drug candidate 'JW1601' (Leopharma project name: 'LEO 152020'), which was licensed out to the global dermatology company Denmark Leo Pharma, has entered global Phase 2 clinical trials.

According to JW Pharmaceutical, Leo Pharma announced on the 15th that it has enrolled the first patient in the Phase 2b clinical trial of JW1601, a new drug candidate for treating moderate to severe atopic dermatitis.

JW1601 was licensed out to Leo Pharma in the preclinical stage in 2018. At that time, the non-refundable upfront payment was $17 million (approximately 20.2 billion KRW), and including milestone payments for clinical development, approval, and commercialization, the total could reach up to $420 million (approximately 476.5 billion KRW). After commercialization, royalties of up to double-digit percentages based on net sales will be paid.

JW1601, being developed as an oral drug, selectively acts on the histamine H4 receptor and has a dual mechanism of action that suppresses inflammation and itching. Histamine is a major mediator of allergic inflammation, and unlike H1 to H3 receptors, the H4 receptor, when bound to histamine, induces itching and regulates the activation and migration of immune cells that cause atopy.

This clinical trial targets adults with moderate to severe atopic dermatitis. After 16 weeks of oral administration, the efficacy and safety will be evaluated by comparing the treatment group and the placebo group. The primary endpoint is the change in Eczema Area and Severity Index (EASI) from baseline to week 16. EASI is a key measure used to assess the severity of atopic dermatitis.

Leo Pharma initiated this Phase 2b trial after completing a dietary effect evaluation clinical trial based on the Phase 1 clinical data conducted by JW Pharmaceutical. The clinical trials will be conducted in Europe, North America, Japan, and Australia.

George Mueller, Senior Vice President of Global Research and Development at Leo Pharma, said, "JW1601 showed promising results for itching in preclinical trials," adding, "We will continue to develop innovative treatments that can improve the lives of patients who need a broader range of treatment options and administration routes for skin diseases."

This content was produced with the assistance of AI translation services.