Galderma Announces Publication of Phase 2b Trial Results Demonstrating the Rapid and Long-lasting Benefits of Nemolizumab in Clinical Trial Subjects With Uncontrolled Atopic Dermatitis

Atopic dermatitis is the most common type of eczema. Moderate to severe atopic dermatitis is a chronic and incurable condition, severely disrupting patients’ quality of life1
The outcome of a post-hoc analysis of the phase 2b study published in the Journal of the European Academy of Dermatology and Venerology provides new possibilities for patients struggling with uncontrolled atopic dermatitis
Clinical trial subjects treated with nemolizumab demonstrated significant itch relief as early as 48 hours after treatment that persisted throughout the duration of the study (up to week 16)2
Subjects treated with nemolizumab reported significant sleep improvements as early as 72 hours after the first injection which were sustained, and improved further throughout the duration of the trial (up to week 16)2
Subjects treated with nemolizumab demonstrated significant improvement in Eczema Area and Severity Index (EASI) at week 16

LAUSANNE, Switzerland--(BUSINESS WIRE)--Galderma today announced that the Journal of the European Academy of Dermatology and Venereology (JEADV) has published full results from a post-hoc analysis of the phase 2b study of its investigational therapy, nemolizumab, in adult patients with moderate-to-severe atopic dermatitis (MtS AD).2 Published online on March 12, results of the analyses show that nemolizumab led to rapid and sustained improvements in itch, sleep, and skin lesions in adult patients with uncontrolled MtS AD.2

The published analysis evaluated the efficacy of nemolizumab versus placebo in adult patients with MtS AD:2

• Nemolizumab-treated patients experienced significant itch relief within 48 hours of treatment (-22.8% vs -12.3%; p=0.005). This improvement was sustained over the trial, achieving even greater treatment benefit at week 16 (-68.5% vs -30.9%; p<0.001 at week 16).
• Rapid improvement of sleep disturbance for patients treated with nemolizumab (30mg) from day three of treatment (-26.6% vs -9.0%; p<0.001) with further improvement by week 16 of treatment (-76.0% vs -36.5%; p<0.001).
• Clinically meaningful reductions of 75% EASI were observed at week 16 in 50.0% of nemolizumab patients versus 15.9% of placebo patients (p<0.001) and 90% reductions of EASI were observed for 36.0% of nemolizumab patients and 6.8% of placebo patients (p<0.001).
• Nemolizumab was safe and well-tolerated in this population, with nasopharyngitis and upper respiratory tract infection being the most common adverse events observed.

“This post-hoc analysis published today in the Journal of the European Academy of Dermatology and Venerology further emphasizes the significant potential of nemolizumab in treating moderate-to-severe atopic dermatitis,” said Dr Baldo Scassellati Sforzolini, Global Head of R&D at Galderma. “In our continued commitment to advancing dermatology, these findings demonstrate the multitude of potential benefits that nemolizumab could bring to people living with this severe and chronic disease.”