LEO Pharma’s Anzupgo® Meets Phase 3 Endpoint in China for Chronic Hand Eczema
LEO Pharma A/S, a global leader in medical dermatology, has announced positive results from the double-blind treatment period of the DELTA China trial. This phase 3 clinical trial evaluates the efficacy and safety of Anzupgo® (delgocitinib) 20mg/g cream, a topical pan-Janus kinase (JAK) inhibitor, for the treatment of moderate to severe Chronic Hand Eczema (CHE) in Chinese adults and adolescents aged 12 and above. The trial is particularly relevant for individuals for whom topical corticosteroids are inadequate or inappropriate.
The DELTA China trial follows a robust study design, consisting of a 16-week randomized, double-blind, vehicle-controlled treatment phase, followed by a 36-week open-label treatment period. A total of 362 subjects were recruited and randomized in a 2:1 ratio to receive either Anzupgo or a cream vehicle. The primary endpoint of the trial, which assessed Investigator’s Global Assessment for Chronic Hand Eczema Score (IGA-CHE TS) at Week 16, was successfully met. Anzupgo demonstrated a statistically significant improvement in CHE severity compared to the vehicle cream.
This milestone is particularly significant in China, where no approved treatment options are currently available for moderate to severe CHE. Given the debilitating nature of the disease, LEO Pharma aims to bridge the treatment gap by offering an effective solution.
Safety and Pharmacokinetics
The 16-week safety profile of Anzupgo remained consistent with previous pivotal trials conducted in other regions. Additionally, pharmacokinetics (PK) data supported low systemic exposure, reinforcing the topical application’s targeted approach. The ongoing open-label treatment period, which extends from Week 16 to Week 52, will further provide long-term data on safety and efficacy.
Objectives and Study Design
The primary goal of the DELTA China trial was to assess the efficacy of twice-daily applications of Anzupgo compared with a cream vehicle in Chinese patients with moderate to severe CHE.
According to Byron Yin, General Manager for LEO Pharma in China, the positive results from DELTA China further highlight the potential of delgocitinib cream as a viable treatment option for patients. He emphasized that LEO Pharma’s extensive history in innovative topicals aligns with their commitment to addressing dermatological unmet needs. He expressed optimism about the full dataset and its implications for expanding access to treatment in China.
Global Implications
The DELTA China trial follows the structured design of the DELTA 1 and 2 phase 3 trials that were previously conducted in Europe and Canada. Both trials successfully met all primary and secondary endpoints, reinforcing the global efficacy of Anzupgo.
Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma, emphasized that DELTA China demonstrates the company’s global commitment to addressing the unmet needs of patients with moderate to severe CHE. He highlighted that dermatological conditions transcend geographical boundaries, and LEO Pharma remains dedicated to advancing treatment options worldwide.
Currently, Anzupgo is approved for adult patients in the European Union, United Kingdom, Switzerland, and the United Arab Emirates for the treatment of moderate to severe CHE. The cream is also under investigation in several other markets, including the United States. The findings from DELTA China will contribute to the growing body of scientific evidence supporting Anzupgo’s efficacy and safety profile.
Future Prospects
LEO Pharma plans to submit detailed DELTA China results for scientific presentation and publication. These findings will provide critical insights for regulatory authorities and clinicians seeking effective treatment alternatives for CHE.
About Anzupgo® (Delgocitinib) Cream
Anzupgo is a topical pan-Janus kinase (JAK) inhibitor designed for the treatment of moderate to severe CHE. It works by inhibiting the activation of JAK-STAT signaling, a pathway known to contribute to the pathogenesis of CHE. The disease is characterized by skin barrier dysfunction, chronic inflammation, and changes in the skin microbiome.
In 2014, LEO Pharma entered into a licensing agreement with Japan Tobacco Inc. (JT), securing exclusive rights to develop and commercialize delgocitinib cream for dermatological use outside of Japan. JT retains commercialization rights within Japan.
Understanding Chronic Hand Eczema
Chronic Hand Eczema (CHE) is a persistent skin condition affecting the hands and wrists, characterized by symptoms such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures. The disease is defined as hand eczema that persists for more than three months or relapses twice or more within a year.
Hand eczema (HE) is one of the most common dermatological conditions, with an estimated prevalence rate of 4.7%. In a significant proportion of patients, HE evolves into a chronic condition, leading to ongoing discomfort and impairment. CHE is a fluctuating disorder marked by periods of exacerbation and remission, often accompanied by severe itching and pain.
Impact on Quality of Life
The burden of CHE extends beyond physical symptoms. The condition significantly impacts psychological well-being and daily functioning. Studies indicate that approximately 70% of individuals with severe CHE experience difficulties in performing everyday tasks, leading to substantial disruptions in their personal and professional lives. Additionally, the economic burden of CHE is notable, as the condition may affect career prospects and earning potential.
