LEO Pharma announced on Friday (February 10) that it has received positive results from its DELTA 2 trial, which is the second of two phase 2 clinical trials with delgocitinab cream.
The cream is an investigational topical pan-Janus kinase (JAK) inhibitor.
Jörg Möller, executive vice president, of European research and development, said: “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.”
The trial met its primary endpoint with a statistically significant improvement in CHE after 16 weeks of treatment with delgocitinib cream compared to cream vehicle, and the treatment was well-tolerated. All or most of the signs and symptoms of CHE were cleared early in the treatment period for a significantly larger proportion of patients treated with delgocitinib cream compared to subjects treated with cream vehicle. DELTA 2 is the second phase 3 trial to achieve its primary and all key secondary endpoints, confirming the positive results of the DELTA 1 trial.
Möller 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.”
Those who completed 16 weeks of treatment in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 extension trial to evaluate the long-term effects of delgocitinib cream. The purpose of this extension trial is to evaluate the long-term effects of delgocitinib.
Further analyses of the data set will be conducted to determine the full potential of delgocitinib cream in the treatment of adults with moderate to severe CHE. Detailed results from DELTA 2 are planned to be submitted for scientific presentation and publication at a later date.
The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) is to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate-to-severe CHE.
CHE is defined as hand eczema that lasts for more than three months or relapses twice or more within a year. It is the most common skin disorder of the hands with a one-year prevalence rate of approximately 9%.
In a substantial number of patients, HE can develop into a chronic condition. CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.
LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society.