Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demo…

ZUG, SWITZERLAND--(Business Wire / Korea Newswire)--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 in JAMA 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]

“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.[1] After 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 patients achieved 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 patients demonstrated 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

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