EADV 2024 Late Breaking Ne

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

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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

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

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

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