ZUG, Switzerland--(뉴스와이어)--Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.[1] Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).[2] These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.

“We’re excited to see the evidence base for nemolizumab continue to build and strengthen for these debilitating diseases, where symptoms such as intense itch can put a significant burden on quality of life. Having already demonstrated nemolizumab’s efficacy and rapid onset of action, these new results show its long-term benefit and durability of response in prurigo nodularis and atopic dermatitis, respectively.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA

Building on the results of OLYMPIA 1 and OLYMPIA 2, the OLYMPIA open-label LTE study is an ongoing 184-week trial to evaluate the long-term efficacy and safety of nemolizumab monotherapy (without topical corticosteroids) in patients with moderate to severe prurigo nodularis who had received nemolizumab in phase II and III lead-in trials as well as those who had previously received placebo (nemolizumab-naïve).[1,4,5]

Results from an interim analysis of the OLYMPIA LTE study demonstrated that nemolizumab treatment provided continuous improvement in skin lesions and itch up to week 52:[1]

· 69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score

· 89% of those who had received continuous nemolizumab treatment and 83% of nemolizumab-naïve patients achieved a significant response on itch intensity as measured by an at least four-point improvement on the peak-pruritus numerical rating scale (PP-NRS)

Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).[1]

Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort. No new safety signals were observed.[1]

Galderma also presented results from an analysis of maintenance data from two pivotal phase III trials of nemolizumab (administered with background topical corticosteroid therapy or topical calcineurin inhibitors) in adolescent and adult patients with moderate to severe atopic dermatitis (ARCADIA 1 and ARCADIA 2).[2,3]

Out of the patients who had clinical responses to skin lesions[*] at week 16 in ARCADIA 1 and 2, the majority maintained skin and itch responses at week 48 when receiving nemolizumab Q4W or Q8W in the maintenance phase:[2]

· 62% of those receiving nemolizumab Q4W and 60% of those receiving nemolizumab Q8W maintained clearance or almost-clearance of skin lesions, when assessed using the IGA score, compared to 50% receiving placebo

· The Eczema Area and Severity Index (EASI)-75 score was also maintained in 76% of those receiving nemolizumab—both Q4W and Q8W—compared to 64% receiving a placebo

· Itch response, as measured by an at least four-point improvement in weekly average PP-NRS score, was similarly maintained in the majority of patients receiving nemolizumab—both Q4W and Q8W—compared to placebo

[*]Defined as patients who achieved an IGA score of clear (0) or almost-clear (1), or a 75% or greater improvement in the EASI score

Response in sleep and quality of life, as measured by the SD-NRS and DLQI scales, respectively, were also well maintained.[2] The safety profile was consistent across treatment arms and most treatment-related adverse events were non-serious and mild/moderate in intensity.[2]

The U.S. Food and Drug Administration (FDA) and European Medicines Agency accepted filing submissions for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis in February 2024. Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis. Further submissions to regulatory authorities in additional countries are planned in 2024.

About prurigo nodularis

Prurigo nodularis is a chronic, debilitating and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas.[6-8]Prurigo nodularis is an underrecognized and underdiagnosed skin disease.[7,9]

About atopic dermatitis

Atopic dermatitis is a common, chronic and flaring inflammatory skin disease characterized by persistent itch and recurrent skin lesions.[10,11] It impacts more than 230 million people worldwide and is the most common inflammatory skin disease.[10]

About the OLYMPIA LTE study

OLYMPIA-LTE is a 184-week open-label study designed to evaluate the long-term efficacy and safety of nemolizumab in patients with moderate to severe prurigo nodularis.[1] The study includes eligible patients with prurigo nodularis from phase II and phase III lead-in studies, including those who received nemolizumab and those who had previously received placebo (nemolizumab-naïve). The study is ongoing.[1]

About the ARCADIA phase III clinical trial program

The ARCADIA program included two identically designed, pivotal phase III clinical trials which enrolled more than 1,700 patients: ARCADIA 1 and ARCADIA 2.[12,13]These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors).[12,13] The trials were conducted in adolescent (12 years and over) and adult patients with moderate to severe atopic dermatitis for an initial treatment phase of 16 weeks, followed by a maintenance treatment phase for up to 48 weeks.[12,13]The two phase III ARCADIA trials met their co-primary endpoints and all key secondary endpoints, demonstrating that nemolizumab rapidly and significantly improves itch, skin lesions and sleep disturbance in patients with moderate to severe atopic dermatitis.[3]

About nemolizumab

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 worldwide, except in Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis. Nemolizumab is under regulatory review for the treatment of patients with prurigo nodularis and moderate to severe atopic dermatitis by the U.S. Food and Drug Administration and European Medicines Agency. Galderma has not received regulatory approval for nemolizumab for any indication in any country to date.

About Galderma

Galderma is the emerging 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] Kwatra, S, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: an interim analysis. Late-breaking abstract presented at AAD 2024.

[2] Silverberg, J, et al. Maintenance of efficacy and safety with nemolizumab at Week 48: results from two global phase III pivotal studies (ARCADIA 1 and ARCADIA 2) in patients with moderate-to-severe atopic dermatitis. Late-breaking abstract presented at AAD 2024

[3] Silverberg J, et al. Nemolizumab improves skin lesions, itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis: Results from two identical phase 3 multinational studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented at EADV 2023

[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. Phase 3 trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. DOI: 10.1056/NEJMoa2301333

[6] Pereira MP, et al. European Academy of Dermatology and Venereology European prurigo project: expert consensus on the definition, classification and terminology of chronic prurigo. J Eur Acad Dermatol Venereol. 2018;32(7):1059-1065. doi:10.1111/jdv.14570

[7] Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183

[8] Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch. 2020;5(4):e42. doi:10.1097/itx.0000000000000042

[9] Kwatra SG, et al. Patient journey and the burden of systemic comorbidities and sequalae in prurigo nodularis. J Drugs Dermatol. 2023;22(12): 12-14. doi:10.36849/JDD.SF365502

[10] Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi:10.1016/S0140-6736(20)31286-1

[11] Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

[12] ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03989349. Last accessed February 2024

[13] ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis. Available online: https://clinicaltrials.gov/study/NCT03985943 Last accessed February 2024

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