Clinical Phase 3 success for topical JAK drug by Leo...

Phase 3 success for topical JAK drug by Leo Pharma


Leo Pharma’s delgocitinib cream has successfully met primary and secondary outcomes in a late-stage medium to severe chronic hand eczema trial, according to the Danish company.

According to the measurement of an investigator’s evaluation of eczema clearing, the drug succeeded in delivering a statistically significant enhancement in chronic hand eczema compared to a placebo ointment. In secondary outcomes, delgocitinib relieved patients of their itch scores as well as pain scores that are measured on the Hand Eczema Symptom Diary.

The EVP (executive vice president) as well as the global R&D head, Jörg Möller stated, “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.”

According to Leo Pharma, the results validate the readout of the recent DELTA 1 trial. The primary and secondary outcomes were also met in the DELTA1 trial. The company now intends to assess the long-term results of delgocitinib in another phase 3 trial.

The drug got approval to treat atopic dermatitis at two dosage potencies in Japan over two years ago in 2020. One year following the approval, the pediatric approval was also received.

If Leo Pharma succeeds in getting an FDA approval for its cream, it would rival the only FDA-approved JAK inhibitor cream in the market that is approved for the treatment of non-segmental vitiligo and atopic dermatitis; Opzelura, which is a product of Incyte.

JAK inhibitors have been thoroughly inspected for safety and frequently come with warnings on the box. Incyte’s Opzelura comes with a list of warnings like a risk of cancer, serious infections, blood clots, heart-related events, and death. Having said that, a GlobalData survey revealed that key opinion leaders are not too bothered about topical JAK medicines’ safety.

Biotech giant Pfizer also announced that its once-daily, oral JAK1 inhibitor called Cibinqo (abrocitinib) has been approved by the FDA for refractory medium to severe eczema (also called AD (atopic dermatitis)) in adolescents. The approval is for adolescents aged between 12 and 18 who did not have the desired response to treatments done using other systemic drugs like biologics. Cibinqo can also be used when other treatments are not suggested.

This approval was as a result of the data from JADE TEEN, a phase III study that examined 100mg and 200mg doses of Cibinqo in patients between the age of 12 and 18 years who were suffering from moderate to severe atopic dermatitis. A total of five studies are done on Cibinqo in the JADE clinical development program and JADE TEEN is one of them. The results from all five studies showed that treatment using Cibinqo resulted in substantial progress in the extent and severity of disease, skin clearance and also fast improvement in itch after 14 days. The results were observed in multiple eczema patients that included adolescents.

There are more JAK inhibitor medications like AbbVie’s Rinvoq, Xeljanz, another drug by Pfizer, and Olumiant by Eli Lilly. However, among these only Rinvoq is approved to treat eczema in adolescents and adults.

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