JW Pharmaceutical said that Leo Pharma, a Denmark-based multinational pharmaceutical firm, has filed an investigational new drug (IND) application for its atopy treatment JW1601 to the U.S. Food and Drug Administration.
|JW Pharmaceutical headquarters in Seocho-dong, Seoul.|
"The IND submission was based on continued cooperation between the two companies in the development of JW1601, the technology of which JW exported to Leo Pharma in August last year," the company said.
JW has been conducting phase 1 clinical trials in healthy adults since January and recently completed the single-dose trial for JW1601 in Koreans.
Clinical results have confirmed the safety and tolerability of the drug up to the fifth stage in its dose-escalation cohort study, which determines the maximum tolerated dose.
Leo Pharma will submit the IND application to the FDA for further research based on phase 1 clinical data performed by JW Pharmaceutical. The trial will be a small clinical trial involving healthy adults and will analyze the pharmacokinetics of the drug.
"We are pleased to see the clinical trial for our atopic dermatitis treatment, which is being developed in oral dosage form, is moving on to the next level," said Kim Kjoeller, Leo Pharma's head of global R&D. "Atopic dermatitis is a disease with very high unmet needs, and the oral treatment JW1601 will substantially affect the quality of life for many patients."
JW Pharmaceutical's head of development Lee Seung-yeol also said, "We were able to smoothly complete the single-dose trial for Koreans and help Leo Pharma in quickly applying for an IND."
JW1601 has a dual mechanism of action that selectively inhibits histamine H4 receptors, which blocks the activity and migration of immune cells that cause atopic dermatitis, and histamine signaling that causes itching. In particular, as an oral agent, the treatment has a new mechanism of inhibiting itching and inflammation caused by atopic dermatitis.
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