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Hand Eczema: LEO Pharma Announces Landmark Phase 3 Data Published in The Lancet

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Hand eczema affects many individuals globally, significantly impacting their quality of life. The publication of the DELTA 1 and DELTA 2 phase 3 clinical trial results by LEO Pharma A/S in The Lancet represents a significant milestone in the treatment landscape for CHE. This is the first time that data on an investigational topical pan-Janus kinase (JAK) inhibitor, specifically delgocitinib cream, has been featured in The Lancet, underscoring its potential importance in dermatological treatments.

The DELTA 1 and DELTA 2 trials were rigorous, randomized, double-blind, multi-center, vehicle-controlled studies designed to evaluate the safety and efficacy of delgocitinib cream compared to a cream vehicle. The trials focused on adult patients with moderate to severe CHE who had either an inadequate response to topical corticosteroids or for whom such treatments were medically inadvisable. Delgocitinib cream, which is still under investigation and not yet approved by any health authority, showed promising results in these trials.

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Hand Eczema Treatment Advances with DELTA Trials

The DELTA 1 trial included participants who used delgocitinib cream or a placebo cream for a specified period. Primary and secondary endpoints were met, indicating significant improvement in CHE symptoms for those using the investigational cream. Similarly, the DELTA 2 trial confirmed these findings, showing consistent efficacy and safety across a broader population of CHE patients. The publication of these results in The Lancet is a testament to the potential of delgocitinib cream to become a new standard of care for CHE.

Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, emphasized the significance of this publication, stating, “Having the DELTA 1 and 2 trial results featured in one of the most highly regarded peer-reviewed medical journals in the world is a vital step on our mission to raise awareness and develop potential new treatment options for those living with CHE.” Madsen also highlighted LEO Pharma’s commitment to pioneering new treatments for skin conditions and the importance of sharing these findings with the broader scientific and medical communities.

The publication of the DELTA trials in The Lancet highlights the increasing focus and quality of research in the field of dermatology, particularly for conditions like CHE that have historically been under-researched. Dr. Robert Bissonnette, Lead Author and MD from Innovaderm Research in Montreal, commented on the importance of these findings, noting that they represent a positive step towards improving the daily lives of individuals with CHE.

Hand Eczema

Hand Eczema Research Gains Traction

The DELTA 1 and DELTA 2 trials met all primary and secondary endpoints, demonstrating the efficacy and safety of delgocitinib cream in treating moderate to severe CHE. These results are particularly significant for patients who have limited treatment options and for whom current therapies may be inadequate. The trials also addressed the chronic nature of CHE, providing long-term data on the benefits and tolerability of delgocitinib cream.

The safety profile observed in the DELTA trials was consistent with expectations for a topical JAK inhibitor, with the most common side effects being mild to moderate and including symptoms such as diarrhea and vomiting. These findings are crucial for understanding the long-term implications of delgocitinib treatment and ensuring its safety for widespread use.

In conclusion, the publication of the DELTA 1 and DELTA 2 trial results in The Lancet represents a significant advancement in the treatment of chronic hand eczema. LEO Pharma’s commitment to developing innovative dermatological treatments is evident in these findings, which have the potential to transform the standard of care for CHE patients. As research continues, the hope is that delgocitinib cream will provide a new, effective treatment option that improves the quality of life for those living with this challenging condition.

Resource: Business Wire, July 19, 2024

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