LEO Pharma provides update on the development program for izuforant

BALLERUP, Denmark, October 20, 2023 – LEO Pharma today announced the initial headline conclusions from the recently completed Ph2a/b study of izuforant (LEO 152020) in atopic dermatitis (LP0190-1488).

Izuforant – which LEO Pharma has in-licensed in a global agreement with JW Pharmaceutical – was a novel atopic dermatitis drug candidate intended for oral treatment of atopic dermatitis. Izuforant was expected to maximize efficacy by dual action of anti-pruritus (anti-itch) and anti-inflammation and minimize adverse events by high selectivity on the target.

The study – a phase 2 randomized, triple-blind, placebo-controlled, parallel-group, international trial to evaluate the efficacy and safety of orally administered izuforant tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis did not meet the primary endpoint; i.e. the trial did not demonstrate a statistically significant difference in the mean change from baseline in EASI total score at end of treatment between active treatment arms and placebo.

No new safety issues or concerns were identified.

"At LEO Pharma, we are committed to advancing the standard of care for people living with skin diseases. This also means investing in trials to explore potential new treatments to accommodate the high unmet need these people face every day. But unfortunately, as is the case for all pharmaceutical research, not all trials show the results we hope for," says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. "While we are disappointed with the outcome for izuforant, which represented a potential new kind of treatment for atopic dermatitis – LEO Pharma remains fully committed to innovative research in atopic dermatitis as we strive to make a difference for people living with skin diseases and their families."

As a result of the study outcome, LEO Pharma has decided to terminate the program and end the licensing agreement with JW Pharmaceutical, who will regain all rights to izuforant

Although this study failed to meet its primary endpoints, the partnership with JW Pharmaceutical is a strong example of LEO Pharma’s commitment to delivering innovation in medical dermatology and reflects LEO Pharma’s research model, which aims at driving the early-stage pipeline through externally sourced innovation, that was announced in early 2023.

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About Izuforant (JW1601)

Izuforant is an orally available histamine H4 receptor inverse agonist with anti-pruritic and anti-inflammatory dual effect. It shows anti-chemotactic activity in eosinophil shape change and therapeutic effect in spontaneous NC/Nga AD model. Izuforant was out-licensed from JW Pharmaceutical to LEO Pharma in 2018.