Galderma Phase III Data

Galderma Phase III Data Published in the New England Journal of Medicine: Full OLYMPIA 2 Trial Results Demonstrate Nemolizumab’s Rapid Onset of Action in Prurigo Nodularis Patients

• The phase III OLYMPIA 2 trial      in patients with prurigo nodularis met all primary and key secondary      endpoints, showing nemolizumab monotherapy significantly and rapidly      improves itch and skin lesions, with clinically meaningful improvements as      early as week 4.¹

• Nemolizumab was well      tolerated, and its safety profile was consistent with phase II trial      results.¹

• Results were published in the      389th edition of the New England Journal of Medicine, which follows      the 2020 publication of nemolizumab’s phase IIB trial results in the same      journal.²

• Nemolizumab is a      first-in-class investigational monoclonal antibody that blocks the      signaling of IL-31, a neuroimmune cytokine responsible for driving      multiple disease mechanisms in prurigo nodularis.

• The OLYMPIA 2 trial is part      of the largest phase III clinical development program in prurigo nodularis      to date.

ZUG, Switzerland -- (BUSINESS WIRE) --

Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis. The trial met both primary and all key secondary endpoints, demonstrating that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo, with a rapid and clinically meaningful response on itch, observed as early as week 4. Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.¹

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“We are proud that the clinical trial results of nemolizumab in prurigo nodularis have been published in the prestigious New England Journal of Medicine for a second time, which is testament to the robustness of our scientific method and quality of evidence supporting its efficacy. We believe nemolizumab has the potential to be a rapidly effective treatment option for patients with prurigo nodularis, with improvements on itch and skin lesions observed as early as week 4.”

FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA

The phase III OLYMPIA 2 trial enrolled 274 adult patients with moderate to severe prurigo nodularis. 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, after 16 weeks of treatment:

• More than twice as many      nemolizumab-treated patients 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 (56.3% vs 20.9%;      p<0.0001).

• More than three times as many      nemolizumab-treated patients reached clearance or almost-clearance of skin      lesions, when assessed using the investigator’s global assessment score,      compared to the placebo group (37.7% vs 11.0%; p<0.0001).

The trial also met all key secondary endpoints confirming rapid responses on itch and sleep disturbance as early as week 4:

• More than five times as many      nemolizumab-treated patients achieved itch response when compared to the      placebo group (41.0% vs 7.7%; p<0.001), as measured by a four-point or      greater reduction in PP-NRS score.

• More than eight times as many      patients achieved a PP-NRS score of less than two, when compared to the      placebo group (19.7% vs 2.2%; p<0.001). Results improved through to      week 16 (35.0% vs 7.7%; p<0.001).

• More than three 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 (37.2% vs 9.9%; p<0.001).      Results improved through to week 16 (51.9% vs 20.9%; p<0.001).

Nemolizumab is an investigational monoclonal antibody specifically designed to target the IL-31 receptor and inhibit IL-31 signaling. IL-31 plays a key role in multiple disease mechanisms in prurigo nodularis, including itch signaling, epidermal changes and fibrosis.^3-7 This includes directly addressing the source of itch, which causes sleep disturbance and negatively impacts quality of life outcomes.^4-8

“Chronic itch is by far the most burdensome symptom for patients with prurigo nodularis, and this is often poorly controlled. The fact that nemolizumab – by inhibiting IL-31 signaling – has the potential to provide a new treatment type that rapidly improves both itch and skin lesions is exciting news.”

DR SHAWN KWATRA, M.D., PH.D.
LEAD STUDY AUTHOR
PROFESSOR OF DERMATOLOGY AT JOHN HOPKINS UNIVERSITY
DIRECTOR, JOHNS HOPKINS ITCH CENTER, UNITED STATES

Galderma is investigating the use of nemolizumab and has not received approval in any jurisdiction for any indication. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of itch associated with prurigo nodularis, a status reconfirmed in March 2023. Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.

To learn more about prurigo nodularis, watch this video from the New England Journal of Medicine. Media can also find more information via the prurigo nodularis media toolkit.

About prurigo nodularis
Prurigo nodularis is a debilitating chronic skin condition characterized by thick skin nodules covering large body areas and associated with intense itch (pruritus).^3,9-10 Prurigo nodularis affects an estimated 72 out of every 100,000 adults aged 18 to 64 in the United States. It is more common in middle-aged women and, disproportionately, people of African descent.^3,11

About nemolizumab
Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.

About the OLYMPIA 2 trial
OLYMPIA 2 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 with prurigo nodularis after a 16-week treatment period. The trial also assessed the pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 included 274 patients with moderate to severe prurigo nodularis.

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 though 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 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

2. 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

3. Williams KA, et al.      Pathophysiology, diagnosis, and pharmacological treatment of prurigo      nodularis. Expert Rev Clin Pharmacol. 2021;14(1):67-77.      DOI:10.1080/17512433.2021.1852080

4. Nemmer JM, et al.      Interleukin-31 signaling bridges the gap between immune cells, the nervous      system and epithelial tissues. Front Med (Lausanne). 2021;8:639097.      DOI:10.3389/fmed.2021.639097

5. Wang F, Kim BS. Itch: a      paradigm of neuroimmune crosstalk. Immunity. 2020;52(5):753-766.      DOI:10.1016/j.immuni.2020.04.008

6. Zhang Q, et al. Structures      and biological functions of IL-31 and IL-31 receptors. Cytokine Growth      Factor Rev. 2008;19(5-6):347-356. DOI:10.1016/j.cytogfr.2008.08.003

7. Tsoi LC, et al.      Transcriptomic characterization of prurigo nodularis and the therapeutic      response to nemolizumab. J Allergy Clin Immunol.      2021;S0091-6749(21)01557-8. DOI:10.1016/j.jaci.2021.10.004

8. Gwillim EC, Nattkemper L,      Yosipovitch G. Impact of itch on sleep disturbance in patients with      prurigo nodularis. Acta Derm Venereol. 2021;101(3):adv00424.      DOI:10.2340/00015555-3778. PMID: 33704503

9. Elmariah S, et al. Practical      approaches for diagnosis and management of prurigo nodularis: United      States expert panel consensus. J Am Acad Dermatol.      2021;84(3):747-760. DOI:10.1016/j.jaad.2020.07.025

10. Whang KA, et al. Prevalence      of prurigo nodularis in the United States. J Allergy Clin Immunol Pract.      2020;8(9):3240-3241. DOI:10.1016/j.jaip.2020.05.051

11. 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