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Galderma Announces New Data Demonstrating the Positive Anti-inflammatory Effect and Mode of Action of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis

Results from transcriptomic (RNA Gene Expression) data now published in the Journal of Allergy and Clinical Immunology:

• Prurigo Nodularis (PN) is a rare, potentially debilitating, chronic neuroimmune skin disease characterized by disfiguring skin nodules covering extensive areas of the body that cause intense itch.

• Nemolizumab is a first-in-class investigational monoclonal antibody that has been shown to block the signaling of IL-31, which plays a key role in the pathogenesis of PN.

• The gene expression data published today provides valuable insight into the mechanism of action of nemolizumab and its positive role in addressing patients with moderate to severe PN.

• The results demonstrate that nemolizumab effectively decreases IL-31 responses in PN skin, leading to suppression of downstream inflammatory responses and improvement in lesions, pruritus and nerve function.

• These data complement previously-published findings from the Phase 2 trial that showed significant improvement of PN lesions and confirmed the rapid onset of action, with over three times greater itch reduction versus placebo within 48 hours of the first dose, and a four-times greater improvement in sleep versus placebo as early as day 4.

December 6, 2021

- Galderma today announced that the Journal of Allergy and Clinical Immunology has published gene expression data that demonstrate the positive anti-inflammatory effect and mode of action of nemolizumab in patients with moderate to severe Prurigo Nodularis (PN), confirming the potential of nemolizumab as a major player in the treatment of PN, effectively reducing both pruritus and severity of skin lesions in PN patients.

“Transcriptome data is an important step in validating the therapeutic effect of nemolizumab through a deeper understanding of the mode of action at a cellular level. With these data, we are advancing dermatology and contributing to improving our understanding of PN. These data emphasize that nemolizumab may have a key role to play for patients with moderate to severe PN. This will be confirmed by our ongoing nemolizumab Phase 3 studies in PN.”

Dr. Baldo Scassellati Sforzolini
Global Head of R&D, GALDERMA

PN is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus. It frequently leads to a severe quality of life impairment. Despite the significant unmet medical needs, there are currently no registered therapeutic options.

The data published today provide the first comprehensive view of the gene expression and transcriptomic changes in PN skin, and characterize the mechanism of action of nemolizumab, supporting previous published data.

The results demonstrate that nemolizumab effectively decreases IL-31 responses in PN skin, leading to effective suppression of downstream inflammatory responses including Th2/IL-13 and Th17/IL-17 responses. This is accompanied by decreased keratinocyte proliferation and normalization of epidermal differentiation and function. The results showed improvement in lesions and pruritus, and stabilization of extracellular matrix remodeling and processes associated with cutaneous nerve function.

“The Journal of Allergy and Clinical Immunology publication demonstrates the broad response to IL-31 receptor inhibition with nemolizumab and confirms the critical upstream role of IL-31 in PN pathogenesis, further supporting the potential benefits of nemolizumab for patients living with this severe, chronic disease.”

Pr. Johann E. Gudjonsson
M.D., Department of Dermatology, University of Michigan, Ann Arbor, MI, U.S.
and lead author of the JACI paper

The full publication is available at www.jacionline.org.

About transcriptomic data
Transcriptomics studies the set of RNA transcripts produced by the genome using high-throughput sequencing and bioinformatics. It can help researchers to gain a deeper understanding of what constitutes a specific cell type, how that type of cell normally functions, and how changes in the normal level of gene activity may reflect or contribute to disease. In clinical drug discovery it provides insight into the mechanism of action of the drug and can help identify possible side effects early in the discovery process.

About nemolizumab
Nemolizumab is a first-in-class humanized monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.i IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and PN, a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus (itching). With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is the bridge between the immune and nervous systems while directly acting on structural cells in the skin. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent under clinical development for the treatment of atopic dermatitis and prurigo nodularis, and its safety and efficacy have not been fully evaluated by any regulatory authority. Nemolizumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis.

About Galderma
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com

i Saleem M. et al. Interleukin-31 pathway and its role in atopic dermatitis: a systematic review. J Dermatology Treat. 2017;28(7):591-599. DOI: 10.1080/09546634.2017.1290205

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