LEO Pharma files IND application to FDA for a clinical study of JW1601/LP0190 in the US

Ballerup, Denmark, and Seoul, Korea, August 27^th, 2019: LEO Pharma, a global leader in medical dermatology, and Korean JW Pharmaceutical today announced that LEO Pharma has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a pharmacokinetics study in the US.

The filing is based on the two companies’ ongoing collaboration on the development of JW1601/LP0190, an oral treatment for atopic dermatitis for which JW Pharmaceutical out-licensed their investigatory drug to LEO Pharma in August 2018. JW Pharmaceutical has since January this year conducted phase 1 clinical trial consisting of a single dose and repeated dose studies in healthy adults. Recently the single dose phase for Koreans was successfully completed with acceptable safety and tolerability observed up to the highest dose, 5^th cohort. Based on this trial LEO Pharma has now filed a protocol for a pharmacokinetics study in US – a small clinical trial with healthy volunteers to further evaluate the pharmacokinetics of JW016/LP0190.

“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. 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”, says Kim Kjoeller, Executive Vice President, Global Research & Development at LEO Pharma.

S.Y Lee, Senior Executive Vice President, Chief of Corporate Development Division said, “As the single-dose study for Koreans has been completed smoothly, LEO Pharma was able to apply for this study plan in US.” He also added that “JW Pharmaceutical will further strengthen our partnership with LEO Pharma in the future and develop JW1601 as a new drug for treatment of atopic dermatitis that will play a pivotal role in the global market.”

JW1601 is a H4R antagonist expected to have anti-pruritic and anti-inflammatory effect in atopic dermatitis. The new drug candidate is developed as an oral treatment, a more convenient route of administration with the potential to improve the compliance for the patient.