LEO LABORATORIES LIMITED

FDA approved tapinarof cream 1% for atopic dermatitis in ages 2 and older, representing a non-steroidal option with a new mechanism of action. It improves skin barrier and reduces inflammation, showing a remittive effect. Over 80% of participants aged 2-17 in ADORING 3 trial achieved clear or almost clear skin, with 52% reporting completely clear skin.

Another market opens for Leo Pharma's Anzupgo, treating moderate-to-severe chronic hand eczema.

The November Chronic Hand Eczema supplement of Dermatology Times covers psychosocial and socioeconomic burdens, LEO Pharma’s CHECK study, and the complexities of CHE, including the lack of FDA-approved treatments. LEO Pharma presented CHECK study data on CHE prevalence and severity, and the European Commission granted marketing authorization for delgocitinib for moderate to severe CHE.

The article introduces Daniel Beck and Karson Putt as authors, detailing their extensive backgrounds in medicinal chemistry and drug discovery, respectively. It also mentions reviewers Pablo Martín-Gago and Ravi Kurumbail, highlighting their significant contributions to the field, particularly in hit discovery and structural biology.

Samuel Simmons, with ichthyosis, spends hours daily scrubbing dry, scaly skin. Research for a cure is slow, with dermatologists repurposing drugs for other skin conditions. Ichthyosis, a family of genetic skin diseases, causes skin cell turnover issues, leading to dry, cracked skin. Despite some progress with retinoids, a cure remains elusive. Dermatologists like Amy Paller and Joyce Teng are exploring immunomodulatory drugs used for psoriasis, revealing shared immune signatures. Clinical trials with IL-17-targeting drugs have shown mixed results, highlighting the need for personalized treatments due to ichthyosis's diversity. Simmons, frustrated but hopeful, keeps an eye on ongoing research.

LEO Pharma announces Swissmedic approval for delgocitinib (Anzupgo) cream, the first topical pan-JAK inhibitor for moderate to severe chronic hand eczema (CHE) in Switzerland. The approval is based on phase 3 DELTA trials, demonstrating efficacy and safety in reducing symptoms. This marks a significant advancement in CHE management, offering a non-systemic, targeted therapy option.

Jasmina Jankicevic discusses how emerging technologies like blockchain, IoT, and AI are transforming clinical trials, emphasizing the importance of real-world evidence and patient-reported outcomes. She predicts decentralized trials will shift CRO roles to more technology-focused services, with AI and machine learning influencing the division of responsibilities between sponsors and CROs. The trend toward precision medicine will lead smaller biotech firms to seek specialized CRO partnerships.

The 2024 Elevate-Derm West Conference reported minimal systemic exposure and favorable safety profile of delgocitinib cream in treating moderate to severe chronic hand eczema, based on the phase 3 DELTA 2 trial. The cream achieved only minimal systemic exposure, with a mean geometric plasma concentration of 0.21 ng/mL at week 1, 0.20 ng/mL at week 4, and 0.17 ng/mL at week 16. Adverse events were minimal, with no cases of malignancy or major cardiovascular events reported.

At the EADV Congress, a poster presented patient experiences of chronic hand eczema (CHE) burden, based on interviews from the DELTA 1 trial. Patients reported significant impacts on daily activities, emotional well-being, and social functioning, with symptoms like cracking leading to pain and bleeding. The study highlighted the high disease burden on quality of life.

LEO Pharma's long-term extension study of Adbry (tralokinumab-ldrm) for atopic dermatitis showed sustained efficacy and safety over five years, with 92.9% of patients achieving a 75% reduction in Eczema Area and Severity Index and 66.7% achieving clear or almost clear skin.