LEO Pharma announces positive phase 3 topline results from DELTA 1 trial with delgocitinib cream in adults with moderate to severe chronic hand eczema (CHE)

BALLERUP, Denmark, December 6 -- LEO Pharma A/S, a global leader in medical dermatology, today announced positive results of the DELTA 1 trial. DELTA 1 is the first of two pivotal phase 3 clinical trials with delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate to severe chronic hand eczema (CHE).

The trial met its primary endpoint with a statistically significant improvement in CHE after 16 weeks of treatment compared to vehicle and the treatment was generally well-tolerated. All or most of the signs and symptoms of CHE were cleared early in the treatment period in a significantly larger proportion of subjects treated with delgocitinib cream compared to subjects treated with vehicle.

“In its moderate to severe form, CHE can cause unbearable recurring symptoms, which negatively impact quality of life, physical functioning and ability to work”, said Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “There are currently no topical treatments specifically developed and approved for the treatment of moderate to severe CHE, making it a challenging disease to treat. We are encouraged by these top-line phase 3 trial results, which show that delgocitinib cream provided fast symptom-relief and could be an efficacious and well-tolerated treatment solution, helping adults suffering from moderate to severe CHE to regain their social and occupational lives.”

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 1 are planned to be submitted for scientific presentation and publication at a later date. In addition to the DELTA 1 trial, delgocitinib cream is also being investigated in the second pivotal trial DELTA 2, which is still ongoing.

For more information on the DELTA 1 trial (NCT04871711) go to clinicaltrials.gov.

About DELTA 1 and DELTA 2
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 vehicle in the treatment of adults with moderate-to-severe CHE.[i]^,[ii]

The primary endpoint of the trials is the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a two-step improvement from baseline. Additional IGA-CHE scores include 2 (mild), 3 (moderate) and 4 (severe).

Key secondary endpoints at Week 16 include reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 defines the key safety endpoint of the trials.  

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year[iii] [iv]. HE is the most common skin disorder of the hands[v] that affects an estimated 1 – 5% of the general population[vi] with a one-year prevalence rate of approximately 9%[vii]. In a substantial number of patients, HE can develop into a chronic condition6 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[viii].

About delgocitinib

Delgocitinib is a first-in-class investigational topical pan-Janus kinase (JAK)-inhibitor that inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases[ix][x]. LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults.

In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights.

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References:

[1] A Elsner P, Agner T. J Eur Acad Dermatol Venereol. 2020;34(Suppl. 1):13–21

[2] ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04871711?term=delgocitinib&draw=1&rank=8 (Accessed May 2021).

[3] ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04872101?term=delgocitinib&draw=1&rank=7 (Accessed May 2021).

[4]Lynde C, et al. Canadian Hand Dermatitis Management Guidelines. J Cutan Med Surg. 2010;14:267–84.

[5] Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.

[6] Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.

[7] Christoffers WA, et al. Interventions for hand eczema. Cochrane Database Syst Rev. 2019;4:CD004055.

[8] Thyssen, et al. The epidemiology of hand eczema in the general population – prevalence and main findings. Contact Dermatitis. 2010;62:75-87.

[9] Thyssen JP, et al.2022: Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis 2022;86:357–378;

[10] Damsky W, et al. JAK inhibitors in dermatology: The promise of a new drug class. Journal of American Academy of Dermatology (JAAD); 2017;76(4):736-744.

[11] Virtanen AT, et al. Selective JAKinhibs: Prospects in Inflammatory and Autoimmune Diseases. BioDrugs. 2019;33:15–32.