Leo Pharma's topical JAK drug posts phase 3 win in chronic hand eczema

Watch out, Incyte: Leo Pharma’s topical JAK inhibitor is catching up.

In a late-stage trial in moderate to severe chronic hand eczema, Leo Pharma's delgocitinib cream met its primary and secondary endpoints, the Danish dermatology specialist said Friday.

Specifically, the drug delivered a statistically significant improvement in chronic hand eczema versus a placebo cream as measured by an investigator's assessment of eczema clearing. As for secondary endpoints, the drug helped relieve patients itch and pain scores as measured on the Hand Eczema Symptom Diary.

“These results bring us one step closer towards establishing delgocitinib as a best-in-class innovative topical treatment for patients affected by this hard-to-treat disease,” Jörg Möller, executive vice president and head of global R&D at Leo, said in a company statement.

The results confirm the recent readout of the DELTA 1 trial, which also met its primary and secondary endpoints, Leo said. Next up, the company aims to evaluate the long-term effects of the drug in a third phase 3 trial.

Back in 2020, the drug won approval in Japan at two dosage strengths to treat atopic dermatitis. A pediatric approval came one year later.

If Leo can score an FDA approval, the treatment would go up against Incyte’s Opzelura, the only FDA-approved JAK inhibitor cream, which is approved to treat atopic dermatitis and nonsegmental vitiligo.

JAK inhibitors have been heavily scrutinized for safety and often come with a boxed warnings. As for Opzelura, that drug's warning lists threats of serious infections, death, cancer, heart-related events and blood clots. However, according to a GlobalData survey, key opinion leaders are not as worried about safety of topical JAK medicines.