Eying Incyte's Opzelura, Leo Pharma shares data for JAK cream in hand eczema

Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s approved topical Opzelura. Now, the Danish dermatology specialist is peeling back the layers on those results.

In the late-stage DELTA 2 trial, 29.1% of patients on a twice-daily dose of Leo’s delgocitinib experienced a noticeable improvement in their moderate to severe chronic hand eczema at the trial's 16-week mark. That compared with 6.9% of trial participants who received a dummy cream, according to an investigator’s assessment of eczema clearing.

Leo unveiled the detailed results Friday at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin. The presentation was among several the company made at EADV, including a pooled analysis that reviewed the effect of delgocitinib cream on health-related quality of life.

Aside from achieving its primary endpoint, delgocitinib also won out on DELTA 2's secondary measures of success, with nearly 50% of patients on Leo’s drug achieving at least a 75% improvement on the Hand Eczema Severity Index. By comparison, 18.2% of patients on a placebo cream saw that level of improvement.

The readout confirms the results from Leo’s identically designed DELTA 1 study, which the company is also sharing at the EADV congress.

That trial, which enrolled 450 adults with chronic hand eczema, also met its primary objective, helping clear all or most signs or symptoms of the condition at 16 weeks. Secondary goals to reduce itch and pain were also met.

Leo is also investigating the long-term effects of its drug in a third phase 3 trial, aptly named DELTA 3.

Delgocitinib cream is already approved in Japan at two dose strengths to treat atopic dermatitis. Following the 2020 nod in that country, the med snagged a pediatric approval in 2021.

If delgocitinib wins the FDA’s blessing, the JAK cream would likely enter a pitched battle with Incyte’s Opzelura. Incyte's drug is currently the only FDA-approved JAK-inhibitor cream, boasting approvals to treat eczema and nonsegmental vitiligo.