Ministry OKs P1 clinical trials for JW’s atopy treatment

Lee Han-soo  Published 2018.11.07  16:06  Updated 2018.11.07 16:06


JW Pharmaceutical said Wednesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) to go ahead with phase 1 clinical trials for “JW-1601,” its atopy treatment candidate.

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.

Also, it has high selectivity for the H4 receptor, which in turn, will reduce the incidence of side effects, the company said.

With the approval, the company plans to evaluate safety and tolerability, drug effects, and biological responses in a total of 88 healthy Koreans and Caucasian at Severance Hospital from the start of next year.

The company also concluded a licensed out agreement with Leo Pharmaceutical, a Denmark-based multinational pharmaceutical company, in August.

Leo Pharma plans to conduct a global phase 2 clinical trial on the drug from 2020.

“It has been confirmed that the drug has a very high safety margin in the preclinical toxicity test (GLP) and a successful clinical trial is expected,” a company official said. “We will develop JW1601 as a therapeutic agent that can cure atopic dermatitis together with Leopama, a global leader in dermatology.”

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