Incyte beat Leo Pharma to the punch with an approval last year for the first JAK inhibitor cream, Opzelura, to treat atopic dermatitis.
But Denmark-based Leo is battling back with its JAK inhibitor cream delgocitinib, posting positive results from a study of patients with chronic hand eczema (CHE).
In the phase 3 DELTA 1 trial of 450 CHE patients, delgocitinib met its primary objective, showing significant improvement after 16 weeks. In the study, in which patients applied cream twice daily, all or most signs or symptoms were cleared early in the treatment period in a larger proportion of the subjects treated with delgocitinib than with a control medication. Secondary goals to reduce itch and pain also were met.
The majority of adverse events observed in the trial were mild and not considered treatment related, according to the press release. Safety issues will be closely monitored with JAK inhibitor creams because oral treatments from the drug class—such as Pfizer’s Xeljanz, Eli Lilly’s Olumiant and AbbVie’s Rinvoq—now carry warnings about increased risk of heart attack and stroke.
Effectiveness of delgocitinib was measured by a scoring system. Success was defined by a two-point improvement on the following scale: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).
“In its moderate-to-severe form, CHE can cause unbearable recurring symptoms, which negatively impact quality of life,” Jörg Möller, Leo’s global R&D chief, said in the release. “There are currently no topical treatments specifically developed and approved for the treatment of moderate-to-severe CHE, making it a challenging disease to treat.”
Incyte’s endorsement for Opzelura covers those with mild-to-moderate eczema. In July of this year, the company tacked on an FDA approval for the treatment in another skin condition, vitiligo.
Opzelura, which is the cream version of the company’s blockbuster Jakafi, generated $38 million in sales in the third quarter. Analysts expect that figure to increase significantly in 2023.
Leo entered the topical JAK inhibitor space in 2014, when it licensed delgocitinib for use outside of Japan in dermatological indications. The company is testing the cream in another phase 3 trial, DELTA 2, which also includes 450 participants.
By Kevin Dunleavy
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