In February, Leo Pharma created a buzz by announcing the success of its JAK-inhibitor cream, delgocitinib, in a phase 3 trial for treating chronic hand eczema. This achievement cast a competitive shadow on Incyte’s approved topical solution, Opzelura. Now, Leo Pharma is providing a closer look at the results.
The late-stage DELTA 2 trial revealed that 29.1% of patients using Leo’s delgocitinib cream twice daily experienced significant improvements in their moderate to severe chronic hand eczema within 16 weeks. In contrast, only 6.9% of those who received a placebo cream saw a similar improvement, as assessed by investigators.
Leo Pharma presented these detailed findings at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin. The company shared several presentations at the event, including a pooled analysis examining delgocitinib cream’s impact on health-related quality of life.
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Beyond meeting its primary endpoint, delgocitinib also outperformed the secondary measures of success in DELTA 2. Nearly 50% of patients using Leo’s product achieved at least a 75% improvement on the Hand Eczema Severity Index, while only 18.2% of those using a placebo cream achieved the same level of improvement.
These results align with those from Leo’s DELTA 1 study, which shared the same design and also achieved its primary objective of clearing or significantly reducing signs and symptoms of chronic hand eczema in 16 weeks. Secondary goals related to reducing itch and pain were also met.
“There is a high unmet need for a topical treatment tailored specifically for CHE. Through assessment of the DELTA 1 and DELTA 2 trial results, we aim to assess the efficacy and safety of delgocitinib cream in adults living with this hard-to-treat disease.”
– Dr Jacob Pontoppidan Thyssen, Executive Vice President and Chief Scientific Officer at LEO Pharma
Leo Pharma is currently investigating the long-term effects of delgocitinib in a third phase 3 trial named DELTA 3.
Notably, delgocitinib cream has already received approval in Japan at two different dosage strengths for the treatment of atopic dermatitis. Following its approval in 2020, it also secured pediatric approval in 2021.
“This latest collection of clinical data for delgocitinib cream supports LEO Pharma’s unwavering commitment to addressing the critical unmet need in CHE. We strive to better support this vastly underserved patient population by investigating a potential new treatment option to treat CHE.”
– Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma
Also Read: Incyte Launches Eczema Awareness Campaign Featuring Actor And Teen Patient On Opzelura
Should delgocitinib obtain FDA approval, it would likely enter a competitive arena with Incyte’s Opzelura. Currently, Incyte’s product is the sole FDA-approved JAK-inhibitor cream, with approvals for treating both eczema and nonsegmental vitiligo. Leo Pharma’s advancements in the field of dermatology present promising alternatives for patients and may foster healthy competition in the market.
