LEO LABORATORIES LIMITED

uniQure has appointed Kylie O'Keefe as Chief Customer and Strategy Officer to lead the global commercialization strategy for AMT-130, the company's investigational gene therapy for Huntington's disease.

LEO Pharma has initiated the DELTA NEXT phase 2a trial to evaluate delgocitinib cream versus placebo in adults with mild to severe palmoplantar pustulosis, a rare inflammatory skin condition.

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

LEO Pharma's investigational IL-22RA1 antagonist temtokibart achieved positive results for the primary endpoint at the three highest doses in a Phase 2b trial for moderate-to-severe atopic dermatitis.

The phase 3 DELTA FORCE trial demonstrated superior efficacy of topical delgocitinib cream over oral alitretinoin capsules for severe chronic hand eczema, with results published in The Lancet.

• Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose. • The OX40 ligand-targeting antibody showed durable effects, with two-thirds of patients maintaining clear or almost clear skin 24 weeks after the final dose, positioning it as a potential complement to Sanofi's blockbuster Dupixent. • Despite increasing competition in the atopic dermatitis market from biologics and JAK inhibitors, Sanofi is advancing amlitelimab to Phase 2b trials, emphasizing the need for diverse treatment options for this challenging condition.

Nearly 50% of patients with moderate to severe chronic hand eczema achieved a "deep response" with delgocitinib cream 20 mg/g by week 16, demonstrating significant relief from disease burden.

A new LEO Pharma survey finds 65% of dermatology providers acknowledge significant knowledge gaps in distinguishing chronic hand eczema (CHE) from atopic dermatitis, highlighting a critical need for education.

LEO Pharma's delgocitinib 20 mg/g cream demonstrated significant efficacy in Phase 3 DELTA TEEN study for adolescents aged 12-17 with chronic hand eczema.

Leo Pharma's Anzupgo has been approved in the UK for treating moderate-to-severe chronic hand eczema, expanding its market reach.