LEO Pharma files investigational new drug application

“As the single-dose study for Koreans has been completed smoothly, LEO Pharma was able to apply for this study plan in the U.S.,” notes S.Y Lee, Senior Executive Vice President, Chief of Corporate Development Division.

LEO Pharma has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for the study of an oral atopic dermatitis treatment, JW1601/LP0190, according to a company announcement. The study is set to take place in the U.S. in 2020.

Korean company, JW Pharmaceuticals, out-licensed the drug to LEO Pharma in August 2018. The drug was originally developed by JW Pharmaceuticals, and was investigated in January 2019 as a single dose in a phase 1 clinical trial conducted in Korea.

“As the single-dose study for Koreans has been completed smoothly, LEO Pharma was able to apply for this study plan in the U.S.,” notes S.Y Lee, Senior Executive Vice President, Chief of Corporate Development Division.

JW1601 is a H4R antagonist designed to block the activation and migration of immune cells that contribute to atopic dermatitis. It is expected to have anti-pruritic and anti-inflammatory effect in patients with the disease.

“We are excited to see the progress of our collaboration with JW Pharmaceuticals that is now enabling us to file the IND application to the FDA and take the next step towards making an oral treatment for atopic dermatitis available,” says Kim Kjoeller, Executive Vice President, Global Research & Development at LEO Pharma. “The unmet needs in this disease area are huge and an oral treatment will add substantially to the treatment options to the benefit of the many people living with this disease.”