Galderma Announces New Data Demonstrating Positive Anti-Inflammatory Effect and Mode of Action of Nemolizumab in Patients with Moderate to Severe Prurigo Nodularis | New


ZUG, Switzerland – (BUSINESS WIRE) – Dec.6 2021–

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

“The transcriptome data is an important step in validating the therapeutic effect of nemolizumab through a deeper understanding of the mode of action at the cellular level. With this data, we advance dermatology and help improve our understanding of PN. These data highlight that nemolizumab may have a key role to play in patients with moderate to severe PN. This will be confirmed by our ongoing phase 3 studies of nemolizumab in PN. “

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

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

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

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

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

Prof. Johann E. Gudjonsson
MD, Department of Dermatology, University of Michigan, Ann Arbor, MI, USA
and main author of the JACI article

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. This can help researchers better understand what constitutes a specific cell type, how that cell type normally functions, and how changes in the normal level of gene activity may reflect or contribute to disease. In clinical drug discovery, this 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-class humanized monoclonal antibody directed against the IL-31 receptor alpha which blocks IL-31 signaling. i IL-31 plays a key role in multiple disease mechanisms in atopic dermatitis and PN, a rare, potentially debilitating chronic skin condition with thick skin nodules covering large areas of the body and associated severe itching ( itching). With its unique role in directly stimulating itch-related sensory neurons and contributing to inflammation and barrier dysfunction, IL-31 is the bridge between the immune and nervous systems while directly acting on structural cells of the the skin. Nemolizumab, originally developed by Chugai Pharmaceutical Co., Ltd., was later licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent in clinical development for the treatment of atopic dermatitis and lumpy prurigo, and its safety and efficacy have not been fully evaluated by any regulatory authority. Nemolizumab received breakthrough therapy designation from the United States 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, with operations in approximately 100 countries. Since our inception in 1981, we have been driven by total dedication to dermatology. We offer an innovative and scientific portfolio of sophisticated brands and services in the fields of aesthetics, consumer care and prescription medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior results. Because we understand that the skin we are in shapes our life stories, we advance 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 treatment. 2017; 28 (7): 591-599. DOI: 10.1080 / 09546634.2017.1290205

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CONTACT: Galderma media contact

Christian Marcoux, M.Sc.

Head of communications

[email protected]

+41 76 315 26 50 Rachel Mooney

Global Franchise Communications

[email protected]

+41 76 261 64 41

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SOURCE: Galderma

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PUB: 12/06/2021 4:00 a.m. / DISC: 12/06/2021 4:02 a.m.

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