Latest news with #LEOPharma
Business Wire
5 days ago
- Health
- Business Wire
LEO Pharma Initiates Phase 2a DELTA NEXT Trial of Delgocitinib Cream in Adults with Mild to Severe Palmoplantar Pustulosis (PPP)
BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced the initiation of the phase 2a proof-of-concept DELTA NEXT trial. The trial aims to evaluate the efficacy and safety of delgocitinib cream compared to cream vehicle in the treatment of adults with mild to severe Palmoplantar Pustulosis (PPP). PPP is the first disease for which LEO Pharma will investigate delgocitinib cream since completion of the Phase 3 DELTA trials in Chronic Hand Eczema (CHE). ' The DELTA NEXT trial in PPP represents an exciting new chapter in the clinical development journey of delgocitinib cream,' said Christophe Bourdon, Chief Executive Officer, LEO Pharma. 'PPP is a disease with few treatment options that can severely affect quality of life. We are hopeful that this therapy could potentially provide much-needed help for patients suffering from this devastating condition.' PPP is an uncommon, chronic, inflammatory, relapsing skin disease characterized by repeated episodes of sterile pustules alongside erythema, blistering and scaly skin on the palms and/or soles of the feet. 3,4 PPP is associated with a high patient burden, resulting in significant impairment of quality of life. Patients often experience pain, fatigue, and the condition can be triggered by factors such as smoking, infections, and stress. PPP is associated with comorbidities such as thyroid dysfunction and metabolic syndrome. 4 There are currently no approved advanced systemic treatments for PPP in the U.S. or Europe. 5 PPP is associated with complex T-cell activation patterns, which may be why many biologics that target individual T helper cell populations have shown limited efficacy in clinical trials. 6 Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor shown to inhibit the activity of all four JAKs, which are involved in inflammatory signaling. 1,2 Using delgocitinib cream's mechanism of action, the trial will investigate the potential benefit of inhibiting multiple JAKs to treat PPP. 'I've seen firsthand how PPP can severely disrupt patients' lives, making it painful to walk, perform activities of daily living and impacting their ability to work,' said Dr. Robert Bissonnette, international coordinating investigator (ICI) on the DELTA NEXT trial and Chairman at Innovaderm Montreal, Canada. 'Despite the significant burden it places on patients, treatment options remain limited. There is a real and urgent need for effective therapies." The DELTA NEXT trial plans to recruit up to 135 patients with active, chronic, mild to severe PPP for whom topical corticosteroids are inadequate or inadvisable. Participants will be recruited across 40-45 sites in the United States, Canada, the United Kingdom, Germany, and Poland. Currently, delgocitinib cream is approved for adults in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate, and is under review in other markets, including the United States. For more information on the DELTA NEXT trial, go to Notes to editors About Delgocitinib Cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor. It prevents the activation of the JAK-STAT pathway by blocking the signaling of several inflammatory cytokines, thereby suppressing the inflammatory cascade and preventing the downregulation of important barrier genes. 7 Delgocitinib cream is currently approved in the European Union, the United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. It is under review in other markets, including the United States. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About the DELTA NEXT Trial DELTA NEXT is a phase 2a, randomized, double-blind, two-arm, vehicle control, adaptive design proof-of-concept trial to assess the efficacy and safety of twice-daily delgocitinib cream compared with cream vehicle in adult subjects with mild to severe PPP. The DELTA NEXT trial plans to recruit up to 135 patients with active, chronic, mild to severe PPP for whom topical corticosteroids are inadequate or inadvisable. Participants will be randomized into a 2:1 ratio to receive either delgocitinib cream or cream vehicle. Participants will be recruited across 40-45 sites in the United States, Canada, the United Kingdom, Germany, and Poland. About Palmoplantar Pustulosis (PPP) Palmoplantar Pustulosis (PPP) is an uncommon chronic, inflammatory, relapsing skin disease characterized by repeated episodes of sterile pustules alongside erythema, blistering and scaly skin on the palms and/or soles of the feet. 3,4 The disease is more common in females, with the estimated prevalence ranging from 0.01% to 0.05%. 3,4 The mean age of patients ranges from 40 to 58 years and is often associated with smoking, thyroid-gland abnormalities, and nickel sensitivity. 4,8 PPP is associated with a significant clinical burden. Patients often experience pain, fatigue, and the condition can be associated with hyperlipidemia and high blood pressure. 8 The condition has been shown to have a greater impairment on work and daily life than plaque psoriasis. 8 About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit References Tanimoto A, Ogawa Y, Oki C, et al. Pharmacological properties of JTE-052: a novel potent JAK inhibitor that suppresses various inflammatory responses in vitro and in vivo. Inflamm Res. 2015;64(1):41-51. Tanimoto A, Shinozaki Y, Yamamoto Y, et al. A novel JAK inhibitor JTE-052 reduces skin inflammation and ameliorates chronic dermatitis in rodent models: Comparison with conventional therapeutic agents. Exp Dermatol. 2018;27(1):22-29. Kharawala S, Golembesky AK, Bohn RL, Esser D. The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review. Expert Rev Clin Immunol. 2020;16(3):239-252. Misiak-Galazka M, Zozula J, Rudnicka L. Palmoplantar Pustulosis: Recent Advances in Etiopathogenesis and Emerging Treatments. Am J Clin Dermatol. 2020;21(3):355-370. Xu JM, Wang HM, Jin HZ. An update on therapeutic options for palmoplantar pustulosis: a narrative review and expert recommendations. Expert Rev Clin Immunol. 2023;19(5):499-516. McCluskey D, Benzian-Olsson N, Mahil SK, et al. Single-cell analysis implicates TH17-to-TH2 cell plasticity in the pathogenesis of palmoplantar pustulosis. J Allergy Clin Immunol. 2022;150(4):882-893. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges [published correction appears in Ther Clin Risk Manag. 2021 Mar 18;17:233.]. Ther Clin Risk Manag. 2020;16:1319-1332. Lebwohl MG, Medeiros RA, Strober B, et al. Palmoplantar Pustulosis has a Greater Disease Burden than Plaque Psoriasis: Real-World Evidence From the CorEvitas Psoriasis Registry. J Psoriasis Psoriatic Arthritis. 2023;8:56–65.
Business Wire
15-05-2025
- Business
- Business Wire
Three-month interim report (Q1) 2025 (Unaudited): LEO Pharma Delivers 9% Revenue Growth at Constant Exchange Rates and Doubles Adjusted EBITDA Margin to 16%
BALLERUP, Denmark--(BUSINESS WIRE)--In Q1, LEO Pharma continued its robust growth, driven by dermatology, and made significant strategic progress. This included expanding the launch of Anzupgo® to five markets, advancing innovation through the newly formed strategic partnership with Gilead for the STAT6 program, and significantly improving profitability with a return to a positive net profit. Q1 2025 highlights LEO Pharma's revenue increased by 10% year-on-year to DKK 3,373 million, and by 9% at constant exchange rates (CER). The revenue growth was led by North America (+45% at CER), with Europe (+2% at CER) and Rest of World (+5% at CER) also contributing to the overall growth. Dermatology portfolio revenue grew by 10% (CER) year-on-year, driven by the Strategic brands, Adtralza®/Adbry® and Anzupgo®, which together saw a revenue increase of 73% (CER). Sales in the Thrombosis portfolio declined by 1% (CER) year-on-year, negatively impacted by order timing. Operating profit improved significantly, with adjusted EBITDA reaching DKK 545 million in Q1 2025, reflecting a margin of 16% (Q1 2024: 8%) excluding the upfront payment from Gilead and other non-recurring items. Net profit for the quarter was DKK 1,742 million (Q1 2024: negative DKK 366 million), including non-recurring items. Free cash flow was positive DKK 1,386 million for Q1 2025 (Q1 2024: negative DKK 571 million), and net interest-bearing debt was reduced to DKK 9,750 million (YE 2024: DKK 11,115 million). Excluding one off M&A-related payments, free cash flow in Q1 2025 was negative DKK 241 million. In Q1, LEO Pharma reported positive results from the DELTA TEEN and DELTA China trials, marking the fifth and sixth consecutive successful phase 3 trials for delgocitinib (brand name: Anzupgo®) in chronic hand ezcema. Additionally, in January, LEO Pharma announced a strategic partnership with Gilead Sciences to accelerate the pre-clinical STAT6 program. The 2025 financial outlook for revenue growth of 6-9% (CER) and an adjusted EBITDA margin of 15-18% is unchanged and confirmed. "We have seen a good start to 2025, with encouraging progress in the ongoing launch of Anzupgo® and key milestones achieved for our innovation pipeline. A significant highlight is the acceleration of the STAT6 program through our new partnership with Gilead. Additionally, the return to a positive net result marks another key milestone for the quarter, as we continue to develop the foundations for LEO Pharma's long-term financial strength,' says Christophe Bourdon, CEO of LEO Pharma. Q1 2025 Financial overview About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit
Business Wire
09-05-2025
- Health
- Business Wire
LEO Pharma announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis
BALLERUP, Denmark--(BUSINESS WIRE)-- NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, today announced positive topline results of the phase 2b trial with temtokibart, an investigational IL-22RA1 antagonist, for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD). The study was a phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, also called LEO 138559, in adult subjects with moderate-to-severe AD. 1 The phase 2b trial achieved positive results for the primary endpoint based on percentage change in EASI (Eczema Area and Severity Index) from baseline to Week 16 for 3 highest doses in adults with moderate-to-severe AD. The treatment was generally well-tolerated, with no dose dependency, and the majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related. ' Atopic dermatitis is a complex immunological condition, and patients living with this debilitating disease still face unmet needs. LEO Pharma is committed to making a fundamental difference for these patients, and we are encouraged by the results of this phase 2b trial, which has explored how to target the disease from a different angle with a different mechanism of action, compared to what is commonly used today to treat AD,' said Dr Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. ' These results further add to the understanding of the mode of action of temtokibart and its potential abilities to address unmet needs in diseases where the IL-22 pathway is known to play a key role – in medical dermatology and beyond.' Temtokibart is an investigational monoclonal antibody for the treatment of moderate-to-severe AD, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with atopic dermatitis. 2-4 LEO Pharma and argenx, a global immunology company, formed a strategic alliance in 2015 to develop innovative antibody-based solutions for the treatment of chronic inflammation that underlies many skin conditions. LEO Pharma and argenx jointly developed temtokibart under this research agreement and LEO Pharma has subsequently obtained the exclusive license to develop and commercialize temtokibart. LEO Pharma is currently collecting and evaluating the full data set. Detailed results from the phase 2b trial are planned to be submitted for scientific presentation and publication at a later date. For more information on the trial (NCT05923099) go to About the Phase 2b trial The temtokibart phase 2b trial (NCT05923099) is a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitits. 1 Patients were randomized to receive one of four doses of temtokibart or placebo. 1 The primary endpoint is percent change in EASI from baseline to Week 16. 1 The key secondary endpoint is number of treatment-emergent adverse events from baseline to Week 16 per subject. 1 About atopic dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 6 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 7,8 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 9,10 About investigational temtokibart Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis. 3,4 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signaling. 3,4 Temtokibart does not bind to the IL-22 cytokine itself. 3,4 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit References NCT05923099. Available at: Accessed September 2024. Bangert C, et al. Presented at European Academy of Dermatology & Venereology (EADV) 2024 Annual Meeting, Amsterdam, 25–28 September 2024. Thaçi D, et al. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, 17–21 March 2023. Thaçi D, et al. Presented at European Academy of Dermatology and Venereology (EADV) 2023 Annual Meeting, Berlin, 11–13 October 2023. Weidinger S, et al. Lancet 2016;387:1109–1122. Boguniewicz M, et al. Immunol Rev 2011;242:233–246. Tubau C, Puig L. Immunotherapy 2021;13:327–344. Bieber T. Allergy 2020;75:54–62. Gittler JK, et al. J Allergy Clin Immunol 2012;130:1344–1354. Nograles K, et al. J Allergy Clin Immunol 2009;123:1244–1252.
National Post
24-04-2025
- Health
- National Post
LEO Pharma Announces Publication of Head-to-Head DELTA FORCE Study Results in The Lancet
Article content DELTA FORCE is the first head-to-head phase 3 trial comparing a systemic and investigational delgocitinib topical treatment for Chronic Hand Eczema (CHE). 1 Article content Article content TORONTO — LEO Pharma A/S, a global leader in medical dermatology, is pleased to share that The Lancet, which is considered one of the most influential peer-reviewed medical journals in the world, has published an article discussing the findings of the DELTA FORCE trial for investigational delgocitinib cream. Article content The publication summarizes the results of DELTA FORCE, a phase 3, two-arm trial (N=513) that compares the efficacy and safety of delgocitinib cream with alitretinoin capsules. 1 Alitretinoin is the only treatment currently approved in Canada to treat severe CHE in patients who do not respond to topical corticosteroids. 2 In Canada and the US, delgocitinib cream is currently under review and has not been approved by Health Canada or the FDA. Article content Article content Delgocitinib cream achieved the primary outcome measure of the DELTA FORCE trial, assessing the Hand Eczema Severity Index (HECSI) scores from baseline to Week 12 compared to alitretinoin capsules. Article content Delgocitinib cream also met all key secondary outcome measures, including Investigator's Global Assessment (IGA)-CHE treatment success, a reduction in HECSI scores from baseline to Week 24, and improvement in health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI). Article content Furthermore, patients receiving delgocitinib cream had fewer treatment-emergent adverse events (AEs) compared to those receiving alitretinoin capsules. Article content 'The discussion of delgocitinib and the presentation of DELTA FORCE data in The Lancet is an exciting moment for the LEO Pharma team,' said Robert Spurr, EVP, LEO Pharma, North America and President, LEO Pharma, US. 'We are proud to contribute to the overall understanding of moderate to severe chronic hand eczema, helping uncover potentially new treatment options for those living with skin conditions like CHE.' Article content 'We know that CHE is an under researched condition,' commented Dr. Charles Lynde, Chief Medical Director, The Lynde Institute for Dermatology & Lynderm Research Inc. and Associate Professor, University of Toronto, Department of Medicine. 'We hope that discussions of the DELTA FORCE program, like that published in The Lancet, will continue to raise awareness of the disease, inspire new research, and ultimately help improve the quality of life of those living with CHE.' Article content DELTA FORCE was a 24-week, randomized, assessor-blinded, active-controlled, parallel-group, phase 3, two-arm trial to compare the efficacy and safety of delgocitinib cream twice-daily with alitretinoin capsules once-daily in adult participants with severe chronic hand eczema. 1 Article content The primary endpoint of the trial was the change in Hand Eczema Severity Index (HECSI) score from baseline to Week 12. Participants assigned to receive delgocitinib cream applied the drug to the skin twice a day for 16 weeks. Participants assigned to receive alitretinoin capsules took the drug orally once a day for 12 weeks. All participants were permitted to continue for up to 24 weeks if the doctor considered that they were benefiting from the treatment. 1 Article content Article content About Chronic Hand Eczema Article content Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 5,6 HE is the most common skin disorder of the hands 7 with a prevalence rate of approximately 4.7%. 8 In a substantial number of patients, HE can develop into a chronic condition. 7 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 2 Article content CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 9 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 10 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 11 Article content Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 12 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 13 Article content In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. Article content Delgocitinib cream is currently approved and marketed under the trade name Anzupgo® in the European Union, United Kingdom, Switzerland and the United Arab Emirates for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Delgocitinib is under investigation in Canada and the United States.
