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Nasal & Pulmonary Drug Development
Novo Nordisk 20 March 2024, 11:21
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Positive data from LEO Pharma’s delgocitinib cream trial

The study involves the treatment of adults with moderate-to-severe chronic hand eczema.

LEO Pharma – a company focused on medical dermatology has revealed positive results from its DELTA 2 trial.

The research is the second of two phase 3 clinical trials incorporating delgocitinib cream – an investigational topical pan-Janus kinase (JAK)-inhibitor – which treats adults with moderate-to-severe chronic hand eczema (CHE).

During the research, the treatment met its primary and secondary endpoints with a significant improvement in CHE following 16 weeks of treatment, compared to the vehicle. Furthermore, the treatment was well-tolerated, and all or most of the symptoms were cleared early on.

Key secondary endpoints also included a reduction of pain and pain scores measured by the ‘hand eczema symptom diary’ from baseline to week 16, as well as at least a 75% improvement from baseline and at least 90% improvement from baseline on hand eczema.

Meanwhile, patients who completed 16 weeks of treatment in both DELTA 1 or DELTA 2 trials were offered participation in the DELTA 3 extension trial to evaluate the long-term effects of delgocitinib cream.

Continued analysis of the data set will be conducted to determine the overall potential of delgocitinib cream – again, in the treatment of adults with moderate-to-severe CHE.

Jörg Möller, executive vice president, of global research and development at LEO Pharma, was encouraged by the latest results: “It is incredibly exciting to see the level of consistency that our DELTA 2 results show in line with the positive DELTA 1 results announced late last year.”

He added: “CHE is a condition that we know can have a hugely negative impact on patient quality of life, physical functioning, and ability to work. 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.”

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