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.
--ENDS--
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.
Kontakter
Henrik Heskjær
Tlf:+45 3140 6180hdtdk@leo-pharma.comJes Broe Frederiksen
Tlf:+45 5360 5948jebfe@leo-pharma.comAbout
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.
Følg pressemeddelelser fra LEO Pharma
Skriv dig op her, og modtag pressemeddelelser på e-mail. Indtast din e-mail, klik på abonner, og følg instruktionerne i den udsendte e-mail.
Flere pressemeddelelser fra LEO Pharma
LEO Pharma announces topline results of phase 3 trial in China for Enstilar® (LEO 90100) demonstrating superiority in adult Chinese subjects with stable plaque psoriasis7.5.2024 20:00:00 CEST | Pressemeddelelse
Enstilar® (LEO 90100) showed superiority over Daivobet® ointment in primary and both secondary endpoints in the testing hierarchy showing improved efficacy in reducing the severity and extent of stable plaque psoriasis. Overall, both Daivobet ointment and Enstilar – each of them LEO Pharma products – were well tolerated. Safety profiles were consistent with previous trial findings and as expected with no new safety concerns identified. The trial is a commitment of LEO Pharma’s expanding presence in China, making a fundamental difference for Chinese patients living with psoriasis through additional treatment options. Enstilar – a unique cutaneous foam formulation built on the active ingredients of Daivobet – is a global market leader in topical psoriasis.
Solid start to the year: 13% revenue growth driven by strong performance in dermatology3.5.2024 09:00:00 CEST | Pressemeddelelse
Q1 2024 Trading Update (Unaudited): In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER). The dermatology portfolio saw accelerated growth in revenue of 16%. The acquisition of TMB-001 to the treatment of congenital ichthyosis added a late-stage asset to LEO Pharma’s medical dermatology pipeline, and delgocitinib for chronic hand eczema (CHE) is on track for its planned European launch in Q4 2024. Full-year outlook has been revised slightly upwards.
Annual report 2023: LEO Pharma delivers 10% revenue growth and returns to positive EBITDA29.2.2024 14:00:00 CET | Pressemeddelelse
Ballerup, February 29, 2024. – LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and an EBITDA uplift of DKK 2.1 billion, corresponding to a 20%-points margin improvement. LEO Pharma exceeded our profitability guidance and hit the upper range of our revenue growth guidance provided in March 2023.
LEO Pharma announces positive phase 3 head-to-head data results from DELTA FORCE trial comparing delgocitinib cream with alitretinoin capsules in adults with severe chronic hand eczema (CHE)24.1.2024 08:00:00 CET | Pressemeddelelse
Delgocitinib cream demonstrated a superior reduction in Hand Eczema Severity Index (HECSI) score from baseline to Week 12 compared to alitretinoin capsules as its primary outcome measure. Delgocitinib cream also demonstrated superiority to alitretinoin capsules in all key secondary outcome measures, including Investigator’s Global Assessment (IGA)-CHE treatment success, health-related quality of life (HRQoL), and a lower number of treatment-emergent adverse events. DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and topical treatment for CHE.1 With only one treatment option currently approved for severe CHE and no approved optionsfor more moderate forms of the disease, there is a considerable unmet need for patients living with CHE.
LEO Pharma finalizes acquisition of key assets from Timber Pharmaceuticals23.1.2024 12:30:00 CET | Pressemeddelelse
Strategic acquisition to expand pipeline, accelerate growth, and meet unmet needs in medical dermatology.
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter samt finde vores kontaktoplysninger.
Besøg vores nyhedsrum