Galderma @ WCD 2023: Late-Breaking Phase III Results for Nemolizumab Monotherapy in Prurigo Nodularis Show a Significant Proportion of Itch-Free Patients by Week 4

ZUG, Switzerland -- Businesswire -- Galderma presented the latest data from its pivotal phase III OLYMPIA 2 trial at the 25th World Congress of Dermatology (WCD) in Singapore. The results highlight the rapid onset of action of nemolizumab monotherapy in patients with prurigo nodularis, with significantly more patients receiving the treatment achieving an itch-free state (indicated by a weekly average peak-pruritus numerical rating scale [PP-NRS] score <2) by week 4, vs. placebo (19.7% vs. 2.2%, p<0.0001). These data expand upon those previously reported, namely a fivefold increase in the number of patients who achieved a clinically relevant improvement in itch intensity (PP-NRS reduction ≥ 4 points) at week 4 (41.0% for nemolizumab vs. 7.7% for placebo, p<0.0001).[1]

The OLYMPIA 2 trial evaluated the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with moderate to severe prurigo nodularis. Topline data were presented to the scientific community earlier this year at the American Academy of Dermatology (AAD). The study met all primary and secondary endpoints, demonstrating that nemolizumab monotherapy significantly improved itch, skin clearance and sleep disturbance. The rapid onset of action was also highlighted, with patients experiencing improvement in itch, sleep intensity and skin clearance as early as week 4. The safety profile was consistent with the phase II results.[3]

Galderma also presented the results of two Galderma-sponsored studies on the significant impact of prurigo nodularis and itch on sleep disturbance at WCD. In a retrospective, population-level, matched-cohort study, patients with prurigo nodularis were found to have a significantly increased risk of insomnia at one year and of sleep apnea at 10 years. In a qualitative study designed to understand how patients experience sleep disturbance related to prurigo nodularis, the majority (71%) reported that their sleep disturbance was solely due to itch.[4,5]

Nemolizumab is an investigational drug specifically designed to target IL-31 signaling to address the underlying causes of the disease. This includes directly addressing the source of itch, thereby improving quality of life outcomes such as sleep disturbance. Data from OLYMPIA 2, also presented at AAD, showed that nearly four times as many patients treated with nemolizumab achieved a significant and clinically meaningful improvement in sleep disturbance, measured by a 4-point improvement on the sleep disturbance numerical rating scale (SD-NRS; 37.2% for nemolizumab vs. 9.9% for placebo p<0.0001).[3]

“The itch associated with prurigo nodularis is uniquely intense, causing significant sleep disturbance that substantially reduces quality of life. These data demonstrate once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

About prurigo nodularis Prurigo nodularis is a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch.[6,7,8] Prurigo nodularis affects an estimated 72 out of every 100,000 adults aged 18 to 64 in the United States. It is more common in middle-aged women and, disproportionately, people of African descent.[6,9]

About nemolizumab Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31. IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis, a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch. With its unique role in directly stimulating itch-related sensory neurons and contributing to inflammation and barrier dysfunction, IL-31 bridges the gap between the immune and nervous systems while acting directly on the skin’s structural cells.

Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. 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. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 - worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.

About the OLYMPIA 2 trial OLYMPIA 2 was a randomized, double-blind, placebo-controlled phase III clinical trial designed to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients aged at least 18 with prurigo nodularis after a 16-week treatment period. The trial also assessed the pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate-to-severe prurigo nodularis.

About Galderma Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story. For further information, please visit www.galderma.com

References: [1] Stander S, et al. Late breaking abstract presented at WCD 2023 [2] Pereira MP, Hoffman V, Weisshaar E, et al. Chronic nodular prurigo: clinical profile and burden. A European cross-sectional study. J Eur Acad Dermatol Venereol. 2020;34(10):2373-2383. doi: 10.1111/jdv.16309 [3] Kwatra SG. Poster presented at AAD 2023 [4] Kwatra SG. Poster presented at WCD 2023 [5] Rodriguez D. Poster presented at WCD 2023 [6] Williams KA, Roh YS, Brown I, et al. Pathophysiology, diagnosis, and pharmacological treatment of prurigo nodu-laris. Expert Rev Clin Pharmacol. 2021;14(1):67-77. doi: 10.1080/17512433.2021.1852080 [7] Elmariah S, Kim B, Berger T, et al. Practical approaches for diagnosis and management of prurigo nodularis: Unit-ed States expert panel consensus. J Am Acad Dermatol. 2021;84(3):747-760. doi: 10.1016/j.jaad.2020.07.025 [8] Whang KA, Mahadevan V, Bakhshi PR, et al. Prevalence of prurigo nodularis in the United States. J Allergy Clin Immunol Pract. 2020;8(9):3240-3241. doi: 10.1016/j.jaip.2020.05.051 [9] Huang AH, Canner JK, Khanna R, Kang S, Kwatra SG. Real-world prevalence of prurigo nodularis and burden of associated diseases. J Invest Dermatol. 2020;140(2):480-483.e4. doi: 10.1016/j.jid.2019.07.697

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