Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demonstrate That Nemolizumab Improves Core Signs and Symptoms of Prurigo Nodularis
Full results from the phase III OLYMPIA 1 trial evaluating the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis have been published in JAMA Dermatology, showing the trial met all primary and key secondary endpoints1 Data were consistent with OLYMPIA 2 trial results, reinforcing the potential of nemolizumab monotherapy to demonstrate rapid and sustained improvements in core signs and symptoms of prurigo nodularis: skin lesions, itch and sleep disturbance – at Week 16 and Week 241,2 In the OLYMPIA 1 trial, a significantly higher proportion of nemolizumab-treated patients achieved an itch-free or nearly itch-free state as early as Week 4 compared to those receiving placebo1 Nemolizumab is a first-in-class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that is known to drive key signs and symptoms of prurigo nodularis3,4
Galderma (SWX:GALD) today announced that full results from the phase III OLYMPIA 1 trial, a 24-week study which evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe prurigo nodularis, were published inJAMA Dermatology.1 The trial met both primary and all key secondary endpoints, showing that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo at Week 16, with a rapid and clinically meaningful response on itch and sleep disturbance observed as early as Week 4.1 Nemolizumab was well-tolerated, and its safety profile was generally consistent with previous studies.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241127699136/en/
“These results, alongside the OLYMPIA 2 trial data, formed the basis of nemolizumab’s recent U.S. Food and Drug Administration approval for the treatment of adults with prurigo nodularis. They demonstrate the potential of this treatment to rapidly and significantly provide relief from the most burdensome symptom for people with prurigo nodularis – itch. We are committed to bringing this treatment option to patients in other parts of the world as soon as possible.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA
|
The phase III OLYMPIA 1 trial enrolled 286 adult patients with moderate-to-severe prurigo nodularis.1,5 Results demonstrated that patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically meaningful and statistically significant improvements in both primary endpoints, compared to placebo.1After 16 weeks of treatment, more than three times as many nemolizumab-treated patients:1
- Achieved an at least four-point improvement in itch intensity, as measured by the peak-pruritus numerical rating scale (PP-NRS), when compared to the placebo group (58.4% vs 16.7%; P<0.001).
- Reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (score of 0 or 1 and a ≥2-point improvement from baseline), compared to the placebo group (26.3% vs 7.3%; P<0.01).
The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as Week 4:1
- More than six times as many nemolizumab-treated patientsachieved itch response when compared to the placebo group (41.1% vs 6.3%; P<0.001), as measured by a four-point or greater reduction in PP-NRS score.
- More than twenty times as many nemolizumab-treated patients achieved a PP-NRS score of less than two, when compared to the placebo group (21.6% vs 1.0%; P<0.001). Results improved through to Week 16 (34.2% vs 4.2%; P<0.001).
- Almost six times as many nemolizumab-treated patientsdemonstrated a four-point improvement in sleep disturbance, as measured by the sleep disturbance numerical rating scale, when compared to the placebo group (31.1% vs 5.2%; P<0.001). Results improved through to Week 16 (50.0% vs 11.5%; P<0.001).
These full results reinforce previous findings from the phase III OLYMPIA 2 trial, published in the New England Journal of Medicine, which demonstrated that nemolizumab rapidly and significantly improved itch and skin lesions in patients with prurigo nodularis, with clinically meaningful responses on itch observed as early as Week 4.2 The OLYMPIA trial program is the largest phase III program in prurigo nodularis completed to date, and the only one to include an open-label, long-term extension study.5-7
“The full phase III OLYMPIA 1 trial results add to the extensive body of evidence supporting nemolizumab’s potential to significantly and safely improve some of the most debilitating symptoms for people with prurigo nodularis – chronic itch, skin nodules, and poor sleep quality – which can be all consuming and have a knock-on effect on patients’ overall quality of life and mental health.”
PROF. SONJA STÄNDER LEAD INVESTIGATOR AND PROFESSOR, DERMATOLOGY UNIVERSITY HOSPITAL MüNSTER, GERMANY
|
Based on data from the OLYMPIA clinical trial program, nemolizumab has been approved by the U.S. Food and Drug Administration for the treatment of adults with prurigo nodularis under the name Nemluvio®.8 Galderma also has marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis under review by multiple additional regulatory authorities, including the European Medicines Agency and via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as Canada, Brazil, and South Korea.9,10 Submissions to regulatory authorities in additional countries are ongoing.
Media can find more information about prurigo nodularis in this media toolkit.
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.11 It is an underrecognized and underdiagnosed skin condition, and while there are limited studies investigating its prevalence, current estimates indicate that up to 181,000 people are living with prurigo nodularis in the United States.4,12-14 The majority of patients report that the persistent itch negatively impacts their quality of life.15 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life.16,17
About nemolizumab
Nemolizumab is a monoclonal antibody developed by Galderma. Under the name Nemluvio®,it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of prurigo nodularis in adults in August 2024, becoming the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis.3,4,8
The U.S. FDA has also accepted for review Galderma’s Biologics License Application for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis, with a decision expected by the end of the year.10 Galderma also has marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis under review by multiple additional regulatory authorities, including the European Medicines Agency and via the Access Consortium framework in countries such as Australia, Singapore, and Switzerland, as well as in Canada, Brazil, and South Korea.9,10
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except 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.18,19
About the OLYMPIA 1 trial
OLYMPIA 1 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 years with prurigo nodularis over a 24-week treatment period.1 OLYMPIA 1 included 286 patients with moderate-to-severe prurigo nodularis.1,5
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. Ständer S, et al. Nemolizumab in Patients with Moderate-to-Severe Prurigo Nodularis: A Randomized Controlled Phase 3 Trial. JAMA Derm. 2024;160. doi: 10.1001/jamadermatol.2024.4796
2. 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
3. Ständer S, et al. Trial of nemolizumab in moderate-to-severe prurigo nodularis. N Engl J Med. 2020; 382:706-716. doi:10.1056/NEJMoa1908316
4. 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
5. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed: September 2024
6. ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed: September 2024
7. ClinicalTrials.Gov. A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed September 2024
8. Galderma. Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Available online. Last accessed: September 2024
9. Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Last accessed: September 2024
10. 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
11. 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
12. Kwatra SG, et al. Prevalence of prurigo nodularis in the United States. J Am Acad Dermatol Int. 2024. doi: 10.1016/j.jdin.2023.12.013
13. Ständer S, et al. Prevalence of prurigo nodularis in the United States of America: A retrospective database analysis. J Am Acad Dermatol Int. 2021;2:28-30. doi: 10.1016/j.jdin.2020.10.009
14. Huang AH, et al. 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
15. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol. 2020;100(8):adv00119. doi: 10.2340/00015555-3471
16. Kwatra SG. Breaking the itch–scratch cycle in prurigo nodularis. N Engl J Med. 2020;382(8):757-758. doi: 10.1056/NEJMe1916733
17. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722
18. 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
19. 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20241127699136/en/
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
Pioneering Impact Strategy, Record EM Sustainable Finance (EMSF), Celebrates Its Fourth Anniversary With Strong Outperformance Since Inception1.7.2025 08:00:00 CEST | Press release
Record Currency Management, in partnership with UBS Wealth Management, is proud to celebrate the fourth anniversary of its pioneering Emerging Market Sustainable Finance (EMSF) Strategy. Operating at the intersection of impact investing, Emerging and Frontier Market currencies and private placements, the strategy offers investors an opportunity to achieve financial returns, alongside measurable impact. Since inception, EMSF has grown to over U$1 billion in AUM and delivered positive returns of +18.7% since inception. The strategy has significantly outperformed both USD and local currency EM Debt benchmarks with around 30% lower volatility - reaffirming that investors need not compromise between financial returns and measurable impact. By taking currency risk across a wide universe of emerging and frontier currencies, EMSF helps MDBs and DFIs raise local currency funding. This allows borrowers in Emerging Markets to receive funding in local currency, eliminating FX risk. Simultaneously,
Lazard Welcomes Klaus H. Hessberger as Managing Director and Global Co-Head of Financial Sponsors Group1.7.2025 07:50:00 CEST | Press release
Lazard, Inc. (NYSE: LAZ) today announced that Klaus H. Hessberger has been appointed to the firm as Managing Director, Global Co-Head, and Head of Europe for Lazard’s Financial Sponsors Group, based in London. Adam Cady, previously Lazard’s Head of Large-Cap Financial Sponsor Coverage North America in New York, has also been named Global Co-Head of the Global Financial Sponsors Group, running the team together with Klaus. These appointments reflect Lazard’s expanding connectivity and partnership with alternative asset managers, which continues to be a principal area of focus and a major source of future growth for the firm globally. Lazard’s recruiting efforts are also a key contributor to the firm’s long-term growth goals, with ongoing success in attracting top tier talent globally. “Klaus is a recognised leader in the global financial sponsor community with an impressive track record of advising global alternative asset managers and leading teams of highly experienced industry profes
Usercentrics Report Reveals: As Concern Over Data Use Grows, Transparency Becomes the Number One Driver for Building Trust1.7.2025 07:28:00 CEST | Press release
Consumer trust is waning as AI and data concerns rise — driving a shift toward Privacy-Led Marketing strategies 59% of consumers are uncomfortable with their data being used to train AI systems, according to a new report from privacy tech leader Usercentrics. But it isn’t AI itself that worries consumers - it’s the lack of clarity around how their data is used. Rather than rejecting innovation, people are demanding greater transparency and control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630843237/en/ How much do consumers trust companies in various industries when it comes to data collection and use? According to the State of Digital Trust 2025report, based on insights from 10,000 frequent internet users across Europe and the United States, digital privacy has become a strategic imperative. “We’re not witnessing a breakdown in trust, but a reset in expectations,” says Adelina Peltea, CMO at Usercentrics. “In the a
Galderma Announces Departure of Its Chief Financial Officer1.7.2025 07:00:00 CEST | Press release
Ad hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that Thomas Dittrich, Chief Financial Officer, will be leaving the company to pursue another senior executive opportunity outside the organization. “We thank Thomas for his financial leadership and many contributions during his time at Galderma. He played a key role in establishing the financial discipline, operational readiness, and strategic clarity that will continue to guide us forward. We wish him every success in his next role and remain focused on further accelerating Galderma’s strong growth – from category leadership to becoming a true powerhouse in dermatology.” FLEMMING ØRNSKOV, M.D., MPH CHIEF EXECUTIVE OFFICER GALDERMA Thomas Dittrich will remain with the company as Chief Financial Officer through Q2 2026 to ensure a seamless transition through the close of the 2025 fiscal year. A successor will be announced in due course. “I want to thank Fle
Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 20:30:00 CEST | Press release
Pacifico Mexinol project, a 6,130 MT per day ultra-low carbon methanol production facility worth more than US$3.3b will be located near Topolobampo, Ahome, Sinaloa. Once operational in 2029, Pacifico Mexinol is poised to be the largest standalone ultra-low carbon chemical production facility in the world. Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s techn
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