Nemolizumab Demonstrates Significant Improvement of AD Symptoms in Phase 2b Trial

In the post-hoc analysis of a phase 2b clinical trial recently published in the Journal of the European Academy of Dermatology and Venereology (JEADV)¹, nemolizumab (Galderma) demonstrated significant improvement in itch, sleep, and skin lesions in adult patients with uncontrolled moderate to severe atopic dermatitis (AD).

Nemolizumab is a humanized monoclonal antibody designed to block signaling from the interleukin (IL)-31 receptor, which is thought to play a role in inflammatory diseases such as AD. The drug is currently being evaluated in clinical trials for AD and prurigo nodularis.¹

“This post-hoc analysis published in [JEADV] further emphasizes the significant potential of nemolizumab in treating moderate-to-severe [sic] atopic dermatitis,” said Baldo Scassellati Sforzolini, MD, PhD, MBA, 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.”

Investigators of the randomized phase 2b trial evaluated the efficacy of nemolizumab compared to placebo in adult patients with moderate to severe AD. Endpoints included a change in Eczema Area and Severity Index (EASI) score at Week 16, Peak Pruritus Numeric Rating Scale (PP‐NRS), Investigator’s Global Assessment (IGA), and changes in sleep and responders with greater than or equal to 4‐point improvement on PP‐NRS.²

Results of the analysis include the following:¹

• Nemolizumab patients had significant itch relief within 48 hours of treatment (-22.8% vs -12.3%; p = 0.005), with a sustained improvement over the trial and achieving 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 3 of treatment (-26.6% vs -9%; p < 0.001) with further improvement by Week 16 (76% vs -36.5%; p < 0.001).
• Reductions of 75% EASI were reported at Week 16 in 50% of nemolizumab patients compared to 15.9% placebo (p < 0.001) and EASI 90 was observed for 36% of nemolizumab patients and 6.8% placebo (p < 0.001).
• Nemolizumab was well-tolerated and safe in this population. The most common adverse events (AEs) observed included nasopharyngitis and upper respiratory tract infection.

"Atopic dermatitis is a chronic and debilitating disease,” said Jonathan Silverberg, MD, PhD, MPH, lead study author, and director of clinical research at George Washington University School of Medicine and Health Sciences. “We particularly need more treatment options for patients with moderate-to-severe [sic] atopic dermatitis. Results from these analyses build on our previous knowledge of nemolizumab’s efficacy in atopic dermatitis and show the potential benefits that it offers for patients with moderate-to-severe [sic] atopic dermatitis.”

References:

1. 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. BioSpace. Accessed April 22, 2021. https://www.biospace.com/article/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/
2. Silverberg JI. et al. Nemolizumab is associated with a rapid improvement in atopic dermatitis signs and symptoms: subpopulation (EASI ≥ 16) analysis of randomized phase 2B study. JEADV. 2021. DOI: 10.1111/jdv.17218