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 vehicle. Furthermore, the treatment was well-tolerated, while all or most of the symptoms were cleared early on.
Key secondary endpoints also included 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, 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.”
by John Pinching
Source: pharmatimes.com
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