JW Pharmaceutical said that LEO Pharma, its Denmark-based partner, has started the global phase 2b clinical trial of JW1601, an oral atopic dermatitis treatment.

The clinical trial aims to evaluate the efficacy and safety of JW1601 by comparing the drug with a placebo in adults with moderate to severe atopic dermatitis for 16 weeks.

The trial's primary endpoint measures changes in the eczema area and severity index (EASI) from baseline to Week 16. Additional exploratory endpoints will evaluate patient-reported symptoms such as itching and sleeplessness.

LEO Pharma plans to conduct the trial in Europe, North America, Japan, and Australia.

"The results on itch in pre-clinical studies with this investigational medicine for patients who prefer oral treatment options were encouraging," LEO Pharma's Executive Vice President for Global Research and Development Jörg Möller said." The company commits to developing innovative therapies that may help improve the lives of patients who need a wider range of treatment options and routes of administration for skin diseases."

JW Pharmaceutical CEO Lee Sung-yeol said, "The announcement is significant that LEO Pharma, a global leader in the field of skin diseases, is conducting global clinical trials of JW1601."

JW Pharmaceutical will strengthen cooperation with LEO Pharma so that an innovative H4 receptor-targeting atopic drug development can be successful, Lee added.

JW Pharmaceutical exported JW1601 to LEO Pharma for $402 million in 2018. JW1601 has a dual mechanism of action that selectively acts on histamine H4 receptors to suppress inflammation and itchiness.

Histamine is a major mediator of allergic inflammation. Unlike H1~3, H4 receptors cause itching when combined with histamine and regulate the activity and migration of immune cells that cause atopic dermatitis.