- LEO Pharma enrolls the first patient for JW1601 phase 2b clinical trial in Europe∙North America∙Japan∙Australia
- Oral type histamine H4 receptor antagonist that suppresses itching and inflammation
2021. 12. 15
The potential new atopic dermatitis drug that was licensed out by JW Pharmaceutical to Denmark-based LEO Pharma, a leader in medical dermatology, is entering global phase 2b dose-ranging clinical trial.
According to JW Pharmaceutical, LEO Pharma has announced on the 15th that they have enrolled the first patient in a phase 2b clinical trial of JW1601 for the potential treatment of moderate-to-severe atopic dermatitis (LEO Pharma project name : LEO 152020).
JW1601 is a new drug candidate for moderate-to-severe atopic dermatitis that was licensed out at a value of 402 million dollars at the preclinical stage by JW Pharmaceutical to LEO Pharma in 2018.
JW1601, which is being developed as an oral dosage form, is believed to have a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching. Histamine is a major mediator for allergic inflammation. The H4 receptor, unlike the H1-H3 receptors, induces itching when combined with histamine, and controls the activation and movement of immunocytes that cause atopic dermatitis.
This clinical trial is targeted at adults suffering from moderate-to-severe atopic dermatitis, and after 16 weeks of treatment, the JW1601 group will be compared with placebo group to evaluate efficacy and safety. The primary endpoint of this trial is the change in (Eczema Area and Severity Index (EASI) from baseline to Week 16. The EASI is a validated scale used globally to assess severity of atopic dermatitis in clinical trials.
LEO Pharma has completed the trial for evaluating food effects based on the data from the phase 1 clinical trial performed by JW Pharmaceutical and is initiating the phase 2b clinical trial. The clinical trial will be conducted in in Europe, North America, Japan, and Australia.
Dr. Jörg Möller, Executive Vice President of Global Research and Development at LEO Pharma, has said that “We have been encouraged by results on itch in pre-clinical studies with this investigational medicine for patients who prefer oral treatment options,” and that “We are committed 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’s CEO Seongyeol Lee said that “there is confidence in the fact that LEO Pharma, a global leader in medical dermatology, is leading the global clinical development of JW1601”, and that “we will strengthen cooperation with LEO Pharma to ensure the development process stays on the path to success.”