LEO Pharma

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 announces positive outcome of DELTA 3 open-label extension trial of delgocitinib cream in the treatment of adults with moderate to severe chronic hand eczema (CHE)30.10.2023 10:00:00 CET | Pressemeddelelse

Subjects who completed the 16-week twice-daily treatment regimen of delgocitinib cream or cream vehicle in the phase 3 DELTA 1 or DELTA 2 trials were offered to immediately enroll into the 36-week DELTA 3 extension trial.1 The DELTA 3 trial evaluated the long-term safety of twice-daily as needed treatment with delgocitinib cream for up to 36 weeks in adults with moderate to severe CHE.1 The long-term safety profile of delgocitinib cream was consistent with previous results from the DELTA 1 and 2 trials. Patients who entered the DELTA 3 trial after receiving delgocitinib cream in the DELTA 1 and DELTA 2 trials maintained similar levels of symptom relief and treatment success over an additional 36-week treatment regimen.

LEO Pharma provides update on the development program for izuforant20.10.2023 09:43:02 CEST | Pressemeddelelse

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.

LEO Pharma Presents New Long-Term Data on Use of Adtralza® (tralokinumab) to Treat Moderate-to-Severe Atopic Dermatitis (AD)13.10.2023 10:35:00 CEST | Pressemeddelelse

A post hoc four-year interim subgroup analysis of the ongoing ECZTEND open-label extension trial assessed whether continuous use of Adtralza provided long-term disease control in adult patients with moderate-to-severe AD.1 Evidence of a safety profile consistent with previous study results for Adtralza was further supported by both the above interim ECZTEND results and an integrated analysis of the ECZTEND trial plus seven of the parent trials.1,2 Initial findings from the cohort study of patients with atopic dermatitis to evaluate tralokinumab real-world clinical use (TRACE).3

LEO Pharma Presents Phase 3 Results of Delgocitinib Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE) at EADV 202313.10.2023 10:35:00 CEST | Pressemeddelelse

Phase 3 DELTA 2 results demonstrated that delgocitinib cream provided statistically significant improvements in both patient- and clinician-reported efficacy outcomes compared to cream vehicle, building on the data from the identically designed DELTA 1 trial.1,2 Additional analysis from the DELTA 2 trial concluded that twice-daily application of delgocitinib cream resulted in minimal systemic exposure, further supporting its safety profile.3

LEO Pharma to Reveal New Findings in Moderate to Severe Atopic Dermatitis (AD) and Chronic Hand Eczema (CHE) at the 2023 EADV Congress12.10.2023 11:00:00 CEST | Pressemeddelelse

New Adtralza® (tralokinumab) data examines the long-term safety and efficacy of the drug for the treatment of moderate to severe AD, as well as its real-world clinical positioning.1,2,3 Delgocitinib cream presentations include new data from the DELTA 2 clinical trials, which assessed the safety and efficacy of the topical treatment for moderate to severe CHE.4,5 Phase 2a trial results assessing the efficacy and safety of temtokibart (LEO 138559), LEO Pharma's IL-22RA1 antibody, will also be presented at the conference.6

Temtokibart achieves First Subject First Treatment (FSFT) milestone in Phase 2b trial11.10.2023 14:00:00 CEST | Pressemeddelelse

Temtokibart, LEO Pharma's investigational IL-22RA1 antibody (formerly labelled as LEO 138559), reaches latest trial milestone. Phase 2b initiation follows the completion of the Phase 2a trial, the results of which were presented at the American Academy of Dermatology (AAD) Annual Meeting earlier this year.1 The trial will be overseen by a steering committee featuring a selection of clinical experts.

LEO Pharma signs agreement to acquire Timber Pharmaceuticals21.8.2023 14:01:37 CEST | Pressemeddelelse

(GLOBAL RELEASE – NOT FOR UK USE – NOT INTENDED FOR UK MEDIA) Ballerup, August 21, 2023 – LEO Pharma today announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. (NYSE American: TMBR. Upon closing, this transaction will add an attractive late-stage asset to LEO Pharma’s pipeline in medical dermatology. The deal is subject to certain closing conditions including, but not limited to, Timber Pharmaceuticals’ shareholder approval.

LEO Pharma Receives Positive CHMP Opinion for New Adtralza® (tralokinumab) Injection Device23.6.2023 07:52:03 CEST | Pressemeddelelse

CHMP recommends approval of the Adtralza pre-filled pen. Adtralza is currently available in a 1 ml pre-filled syringe. Administration with the 2 ml pre-filled pen requires half the number of injections, with a single dose given every other week, and simplifies the process with a hidden needle and press-down auto-injection. Following positive opinion from the CHMP, a final decision from the European Commission is pending.

Danish Medicines Council recommends Adtralza® (tralokinumab) as first line biologic treatment option in new treatment guideline for atopic dermatitis27.4.2023 15:33:37 CEST | Press release

• The Danish Medicines Council today published a new treatment guideline for atopic dermatitis • In the guideline Adtralza (tralokinumab) is recommended as a first line treatment for moderate-to-severe atopic dermatitis patients aged 12 years and older who are eligible for biological treatment • Adtralza is now available for eligible patients in 15 countries around the world

LEO Pharma presents late-breaking positive Phase 2a efficacy and safety results of LEO 138559 in moderate-to-severe atopic dermatitis at the 2023 AAD Annual Meeting18.3.2023 21:10:00 CET | Press release

• Results presented at AAD 2023 demonstrated that investigational agent LEO 138559 met its primary endpoint of change in the Eczema Area and Severity Index (EASI) compared with placebo1 • Efficacy analysis showed significant improvement versus placebo across a variety of endpoints including EASI-75, EASI-90, and EASI-100, in adult patients with moderate-to-severe atopic dermatitis1 • These results are the first to be presented for an IL-22 receptor targeting antibody for the treatment of moderate-to-severe atopic dermatitis1

LEO Pharma Presents Late-Breaking Positive Phase 3 Results of Delgocitinib Cream in Adults with Moderate to Severe Chronic Hand Eczema (CHE) at AAD 202318.3.2023 17:40:00 CET | Press release

• Results demonstrated that delgocitinib cream provided statistically significant improvements in primary and all key secondary endpoints, which included both clinician-assessed and patient-reported efficacy outcomes compared to cream vehicle.1 • Delgocitinib cream showed a statistically significant treatment effect compared to cream vehicle as early as four weeks after initiation of treatment.1
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