Business Wire

GALDERMA

Share
Galderma @ AAD 2024: New Data Demonstrate the Long-Term Efficacy of Nemolizumab in Prurigo Nodularis and Its Durability in Atopic Dermatitis

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240310697617/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

CapVest and Parquest Agree Terms on IPN’s Acquisition of Sopral8.7.2025 10:00:00 CEST | Press release

Inspired Pet Nutrition (“IPN”), the fast-growing pet food company controlled by CapVest Partners LLP (“CapVest”), and Parquest, a leading investment firm, have agreed terms on the acquisition of Sopral, a prominent branded pet food platform serving the European market, with manufacturing operations based in France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250708134461/en/ Sopral products The transaction is subject to customary regulatory approvals and closing conditions. Financial terms have not been disclosed. Based in Pléchâtel, Brittany, France, Sopral is a leading manufacturer of branded premium dry petfood with a comprehensive range of high-quality nutritional solutions, including Pro-Nutrition Prestige, Pure Life and Protect brands. Sopral has a strong footprint and reputation in France and a fast growing online and international market presence in over 50 countries around the world. Employing over 130 people, th

Thales Reinforces its Leadership in eSIM and IoT Connectivity with a ‘Ready to Use’ Certified Solution8.7.2025 08:00:00 CEST | Press release

At a time when billions of connected objects are reshaping industries, Thales has achieved an essential security certification for its eSIM solution, reinforcing its leadership in trusted connectivity management for the Internet of Things (IoT). The certification, granted by the GSMA under the eSIM Security Assurance (eSA) scheme, marks a significant milestone in enabling large-scale, secure, and efficient IoT deployments across industries including smart metering, healthcare, and automotive. This positions Thales as a trusted partner capable of providing full protection against advanced cyber threats — delivering end-to-end security solutions, from chip to cloud, and ensuring compliance with emerging security standards (e.g., the EU Cyber Resilience Act). With over 5.8 billion IoT cellular connections expected globally by 2030 (GSMA Intelligence), businesses and industries face growing pressure to deploy connected devices at scale — securely and efficiently. The SGP.32 IoT specificati

Invivoscribe Expands Flow Cytometry Services to Accelerate CAR-T Immunotherapy Development and Regulatory Readiness with the Initiation of CERo Therapeutics Phase 1 Clinical Trial8.7.2025 06:00:00 CEST | Press release

Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to support CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms. Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories) have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to supportCERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML. AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chime

Tigo Energy Adds Solar-Plus-Storage Portfolio in Czech Republic to Build on MLPE Success8.7.2025 06:00:00 CEST | Press release

Successful PPDS P4 protocol certification opens full range of three-phase Tigo EI Inverters and the EI Residential product suite for grid connection in second-strongest E.U. market for Tigo. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that the Company’s entire portfolio of three-phase Tigo EI Inverters has successfully passed the certification tests for compliance with the PPDS P4 requirements in the Czech Republic. Compliance with PPDS P4, formally known as Distribution System Operation Rules, Annex 4, is a prerequisite for grid connection of solar inverters in the Czech Republic, validating the compatibility with the technical conditions defined by the European Commission and adopted by local utility companies. In the wake of the proliferation of rapid shutdown requirements across Europe, with installers in the Czech Republic deploying nearly 107MW of Tigo MLPE in 2024, Tigo products ha

Murata Launches World’s First High-Frequency Filter Using XBAR Technology for 5G, Wi-Fi 7, and Future 6G Networks8.7.2025 04:00:00 CEST | Press release

Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has announced the mass production and commercial shipment of the world’s first*1 high-frequency filter using XBAR technology*2. Developed by combining Murata’s proprietary Surface Acoustic Wave (SAW) filter expertise with XBAR technology from Murata's subsidiary Resonant Inc., it enables the extraction of desired signals while achieving both low insertion loss and high attenuation. These features are critical for the latest wireless technologies, including 5G, Wi-Fi 6E, Wi-Fi 7, and emerging 6G technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250707682186/en/ [Murata Manufacturing Co., Ltd.] The world’s first high-frequency filter using XBAR technology The demand for reliable high-frequency communications continues to grow in response to the widespread deployment of 5G and the future development of 6G. Simultaneously, wireless local-area network (W

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye