JW Jungwoo's 'Oral Atopy New Drug' Approved for Phase 2 Clinical Trial in Germany

[Asia Economy Reporter Junhyung Lee] JW Pharmaceutical's oral atopy drug candidate substance (JW1601) has received approval in Germany for a Phase 2a clinical trial plan to confirm its efficacy in treating cholinergic urticaria, a temperature allergy.

On the 19th, according to the European clinical trial registration site 'EU Clinical Trials Register,' the Phase 2a clinical trial plan for JW1601 (Leo Pharma development code name LEO 152020) was approved by the German Federal Institute for Drugs and Medical Devices (BfArM).

Leo Pharma plans to evaluate the efficacy and safety of JW1601 compared to a placebo in 28 adult patients suffering from cholinergic urticaria.

JW Pharmaceutical licensed this substance to Denmark's Leo Pharma in August 2018 during the preclinical stage. The contract was valued at a total of $420 million (approximately 450 billion KRW).

JW1601 selectively acts on the histamine H4 receptor and blocks the activation and migration of immune cells that cause atopic dermatitis. It also suppresses the signal transmission of histamine that causes itching.

This substance is being developed as an oral medication, which is expected to improve patient convenience in administration. With this clinical entry, Leo Pharma is expanding the treatment scope of JW1601 beyond atopic dermatitis to other skin diseases.

Cholinergic urticaria occurs when body temperature rises due to excessive exercise or bathing. Multiple small, millet-like lesions appear, accompanied by stinging pain and itching.

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