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LEO Pharma files IND application to FDA

LEO Pharma and Korean JW Pharmaceutical have 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.

The single dose phase for Koreans was successfully completed

Recently the single dose phase for Koreans was successfully completed with acceptable safety and tolerability observed up to the highest dose, 5th 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.

Anti-pruritic and anti-inflammatory effect in atopic dermatitis

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.

Photo of Kim Kjoeller: LEO Pharma