LEO Pharma

LEO Pharma provides update on the development program for izuforant

  • The Phase 2a/b 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 AD did not meet the primary endpoint.
  • As a result, LEO Pharma ends the program for izuforant and terminates the license agreement with JW Pharmaceutical.
  • LEO Pharma remains committed to delivering value for patients living with atopic dermatitis and other skin diseases.

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.


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.



About JW Pharmaceutical Corporation

JW Pharmaceutical Corporation has been leading Korean medicine and medical supplies market over its 70 years of history. The company focuses on the field of research and development of anti-cancer drug and etc.; manufacture and sales of hospital fluid, antibiotic and other ethical pharmaceuticals.

JW Pharmaceutical Corporation was founded in 1945 and is listed on the Korea Exchange Market under the symbol "001060".

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,400 people, serving millions of patients across the world. In 2022, the company generated net sales of DKK 10.6 billion.

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