[Photo provided by JW Pharmaceutical]
South Korean drug maker JW Pharmaceutical’s investigational oral atopic dermatitis drug has been cleared for a phase 2a clinical trial for the treatment of cholinergic urticaria in Germany.
According to EU Clinical Trials Register on Monday, the phase 2a trial protocol for JW1601 (LEO 152020) filed by LEO Pharma was approved by Germany’s health authorities (BfArM).
LEO Pharma will evaluate the efficacy and safety of JW1601 compared to placebo in 28 adults with cholinergic urticaria.
In August 2018, JW Pharma entered a $402 million global licensing agreement with Denmark-based LEO Pharma to develop and commercialize JW1601.
JW1601 is designed to prevent the activation and migration of immune cells that cause atopic dermatitis by selectively targeting the histamine H4 receptor and inhibiting histamine signaling responsible for itching.
The drug is expected to be developed as an oral formulation that is convenient and cost effective.
LEO Pharma is anticipated to explore the treatment potential of JW1601 in other diseases beyond atopic dermatitis.
Cholinergic urticaria also referred to as heat bumps is a type of skin rash accompanied by pain and itching that occurs in some people when their body gets too warm and sweats after excessive exercise or physical stress.
JW Pharmaceutical’s shares closed Tuesday unchanged at 30,650 won ($27.56).
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