EADV 2024 Late Breaking News Sessions: New Galderma Data Demonstrating Nemolizumab’s Long-term Efficacy and Safety in Atopic Dermatitis and Durability in Prurigo Nodularis to Be Shared During Three Oral Presentations

• New 56-week data from an interim analysis of the phase III ARCADIA long-term extension study will be presented, with nemolizumab demonstrating a continuous improvement in clinically meaningful responses to signs and symptoms of atopic dermatitis for more than one year¹
• Novel biomarker data from the phase III ARCADIA study will also be shared during an oral presentation, with nemolizumab demonstrating a significant effect on various biomarkers linked to core features of atopic dermatitis, including itch, skin lesions, and inflammation²
• Data from the OLYMPIA DURABILITY phase IIIb study demonstrated the clinical benefits of continued use of nemolizumab beyond 52 weeks in clinically responsive prurigo nodularis patients³

ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that it will present new data from the ARCADIA and OLYMPIA clinical trial programs investigating nemolizumab in atopic dermatitis and prurigo nodularis, respectively, at the 2024 European Academy of Dermatology and Venereology (EADV) congress in Amsterdam during three separate oral presentations. These late-breaking data will be presented on Wednesday, September 25, including long-term efficacy and safety results from an interim analysis of the phase III ARCADIA long-term extension study and novel biomarker analyses of nemolizumab in adolescents and adults with moderate-to-severe atopic dermatitis.^1,2 Additionally, encouraging data from the phase IIIb OLYMPIA DURABILITY study documenting durability of response to nemolizumab in adults with prurigo nodularis will also be presented.³

These new data build on previously published results from the robust phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated nemolizumab’s favorable safety profile and efficacy on itch, skin lesions and sleep disturbance in atopic dermatitis and prurigo nodularis, respectively.^4-6 Nemolizumab specifically inhibits IL-31 cytokine signaling, which is known to drive key symptoms, such as skin inflammation, in both of these chronic skin conditions.^7,8

“These late-breaking data further highlight the potential of nemolizumab as an effective, long-term therapeutic option for patients with atopic dermatitis and prurigo nodularis seeking relief from itch and skin lesions. We remain steadfast in our efforts to bring this potential treatment to patients who need it the most across the world.”   BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

Interim results from the ARCADIA long-term extension study at Week 56 demonstrate that continuous nemolizumab treatment leads to clinically meaningful improvements in skin lesions, itch, sleep, and quality of life that increase over time in atopic dermatitis

The ARCADIA long-term extension study enrolled patients from various phase II and phase III studies, including the pivotal phase III ARCADIA 1 and ARCADIA 2 clinical trials (called lead-in studies), to evaluate the long-term safety and efficacy of nemolizumab administered with background topical corticosteroids, with or without topical calcineurin inhibitors, in adolescents and adults with moderate-to-severe atopic dermatitis, over four years of treatment.^1,9

Results from a 56-week interim analysis to be presented at EADV 2024 demonstrate that clinically meaningful improvements in skin lesions continued to increase up to Week 56 for atopic dermatitis patients who were previously exposed to nemolizumab in the lead-in study, compared to when they entered the long-term extension study:¹

• 47% of evaluable patients who were previously exposed to nemolizumab achieved clear or almost clear skin, as defined by an Investigator’s Global Assessment (IGA) score of 0 or 1, respectively, up from 29%.
• 73% of evaluable patients who were previously exposed to nemolizumab achieved a 75% improvement in the Eczema Area and Severity Index (EASI) score from baseline of their lead-in study, up from 38%.

The data also demonstrate that improvements in itch, sleep, and quality of life continued to increase over time up to Week 56, and that nemolizumab’s safety profile is consistent with that previously reported in the ARCADIA clinical trials.^1,6

“Many atopic dermatitis patients struggle to achieve holistic symptom relief with currently available treatments, and the few that do continue to seek treatments with longevity. These new data will add to the growing body of evidence demonstrating the potential long-term benefit of nemolizumab in atopic dermatitis, with patients seeing improvements in skin lesions, itch, and quality of life outcomes that continue to increase over time, for more than a year.”   PROFESSOR DIAMANT THAÇI LEAD INVESTIGATOR OF THE ARCADIA LONG-TERM EXTENSION STUDY UNIVERSITY OF LUBECK, GERMANY

Additional late-breaking data from the core phase III ARCADIA clinical trials demonstrate nemolizumab’s effect on biomarkers that are linked to features of atopic dermatitis

Novel biomarker data from the phase III ARCADIA clinical trials will also be presented, substantiating that targeting of IL-31 signaling with nemolizumab helps to address key features of atopic dermatitis.² The data demonstrate that treatment with nemolizumab results in a significant reduction of various biomarkers involved in itch, skin lesions, and inflammation, which also correlates with improvements in clinical outcomes, and that patients with severe itch show more robust reduction in these biomarkers, indicating that nemolizumab may hold even greater promise in patients who are most impacted by this burdensome symptom.²

OLYMPIA DURABILITY study data demonstrates clinical benefits of continued use of nemolizumab for more than one year in responsive prurigo nodularis patients

OLYMPIA DURABILITY is a 24-week phase IIIb withdrawal study conducted in adults with prurigo nodularis. The study included 34 patients who participated in the OLYMPIA long-term extension study and achieved a clinical response, as defined by an IGA score of 0 (clear) or 1 (almost clear) and an at least four point improvement in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score from baseline of their lead-in study at Week 52.^3,10,11

The study met its primary endpoint; results to be presented demonstrate that clinically responsive patients at Week 52 have significantly lower relapse rates (17%) when continuing nemolizumab therapy than those withdrawn from treatment (75%) after 24 weeks.³ These data support the continued use of nemolizumab beyond 52 weeks for patients who are clinical responders and confirm its long-term efficacy.³ In the study, relapse was defined as an at least four-point increase in the PP-NRS score and/or an at least two-point increase in IGA score from baseline.³

The data also demonstrate that nemolizumab’s safety profile is consistent with that previously reported in the OLYMPIA 1 and OLYMPIA 2 pivotal clinical trials.^3-5

“People living with prurigo nodularis suffer from chronic, severe itch, which disrupts their quality of life, and visible skin lesions, which can impact their self-confidence. These new long-term data demonstrate that nemolizumab’s efficacy on itch and skin lesions in prurigo nodularis is maintained for over one year, and also show that continuous treatment is necessary to ensure that these burdensome symptoms remain controlled.”   PROFESSOR FRANZ LEGAT LEAD INVESTIGATOR OF THE OLYMPIA LONG-TERM EXTENSION AND DURABILITY STUDIES DEPARTMENT OF DERMATOLOGY AND VENEREOLOGY MEDICAL UNIVERSITY OF GRAZ, GRAZ, AUSTRIA

Media can find more information about atopic dermatitis and prurigo nodularis in this media toolkit, and can watch this video to find out more about the burden of itch for people living with these skin conditions.

About nemolizumab

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^12,13

Nemolizumab is approved in the United States (under the name Nemluvio^®) for the treatment of adults with prurigo nodularis, with the U.S. Food and Drug Administration’s (FDA’s) decision on atopic dermatitis expected later this year.¹⁴ Galderma’s marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework.^15,16 Further submissions to other regulatory authorities will continue throughout 2024.

About Galderma

Galderma (SIX: GALD) 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 are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

1. Thaçi D, et al. Nemolizumab long-term safety and efficacy up to 56 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Late-breaking abstract presented at EADV 2024
2. Guttman-Yassky E, et al. Tape-strips transcriptomic analysis from patients with moderate to severe atopic dermatitis treated with nemolizumab. Late-breaking abstract presented at EADV 2024.
3. Legat FJ, et al. Durability of response to nemolizumab in patients with moderate-to-severe prurigo nodularis: Results from a randomized placebo-controlled withdrawal Phase 3b study. Late-breaking abstract presented at EADV 2024
4. Ständer S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1): Late breaking abstract presented at EADV 2023
5. Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333
6. Silverberg JI, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0
7. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
8. Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2
9. ClinicalTrials.Gov. Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis. Available online. Last accessed September 2024
10. ClinicalTrials.Gov. A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed September 2024
11. ClinicalTrials.Gov. A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis. Available online. Last accessed September 2024
12. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Last accessed September 2024
13. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Last accessed September 2024
14. Galderma. Galderma receives U.S. FDA approval for Nemluvio^® (nemolizumab) for adult patients living with prurigo nodularis. Available online. Last accessed: September 2024
15. Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Last accessed: September 2024
16. Galderma. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. Available online. Last accessed: September 2024