Galderma Announces Positive Data From Phase III Trial, Demonstrating Efficacy and Safety of nemolizumab in Patients with Prurigo Nodularis

Prurigo nodularis is a rare, potentially debilitating, inflammatory skin disease characterized by disfiguring skin nodules often covering extensive areas of the body, and an intense and chronic itch
There are currently no approved therapeutic options
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a key neuroimmune cytokine involved in the pathogenesis of prurigo nodularis
This phase III trial met both primary endpoints, confirming nemolizumab monotherapy significantly improved skin lesions and pruritus (itch) in adult prurigo nodularis patients
The trial also met all key secondary endpoints, with a safety profile consistent with the phase II trial results

News provided by Galderma
June 22, 2022 16:00

ZUG, SWITZERLAND--(Business Wire / Korea Newswire) June 22, 2022 -- Galderma today announced the phase III OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus (itch) compared with placebo in adult patients with moderate to severe prurigo nodularis. The safety profile was consistent with the phase II trial results.

“Prurigo nodularis is known to have a profoundly negative impact on quality of life with currently no approved therapeutic options. These phase III trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis.”

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

OLYMPIA 2, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, is a pivotal phase III clinical trial, evaluating the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period.

Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvement in both primary endpoints compared to placebo after 16 weeks of treatment:

· 38 percent of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score, compared to 11 percent in the placebo group (p<0.0001).
· 56 percent of nemolizumab-treated patients achieved an at least four-point reduction in itch, as measured by the peak-pruritus numerical rating scale (PP-NRS) score, compared to 21 percent in the placebo group (p<0.0001).

The trial also met all key secondary endpoints. Data confirm early onset of action on itch, skin lesions and sleep disturbance. Nemolizumab demonstrated a favorable benefit-risk balance in this trial.

“The results of OLYMPIA 2 provide further evidence that nemolizumab effectively improves skin lesions and pruritus in patients with prurigo nodularis. We are encouraged by the strength of these data, that once again highlight the potential of nemolizumab for patients living with this severe and chronic disease.”

PROFESSOR SONJA STÄNDER
LEAD INVESTIGATOR AND PROFESSOR, DERMATOLOGY
UNIVERSITY HOSPITAL MUENSTER
GERMANY

A second phase III trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing. The OLYMPIA 1 trial has a similar design to OLYMPIA 2.

About nemolizumab
Nemolizumab is a first-in-class investigational monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31. IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis, a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus (itch). With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is the bridge between the immune and nervous systems while directly acting on structural cells in the skin.

Nemolizumab is approved in Japan for pruritus associated with atopic dermatitis and is under clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 - worldwide except Japan and Taiwan.

About the OLYMPIA 2 trial
OLYMPIA 2 is a randomized, double-blind, placebo-controlled phase III clinical trial, to assess the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with prurigo nodularis after a 16-week treatment period. The trial also assesses pharmacokinetics and immunogenicity of nemolizumab compared to placebo. OLYMPIA 2 includes 274 patients with moderate-to-severe prurigo nodularis.

About prurigo nodularis
Prurigo nodularis is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated intense itch.[i] Prurigo nodularis affects an estimated 72 per 100,000 adults aged 18-64 years in the United States, primarily middle-aged women and disproportionately people of African descent.[ii,iii]

About Galderma
Galderma 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 though Injectable Aesthetics, Dermo-cosmetics 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’re in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

[i] Galderma. Data on File. Press Release. Galderma presents new nemolizumab data at EADV. 2021.
[ii] Williams KA, Roh YS, Brown I, 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
[iii] Huang AH, Canner JK, Khanna R, Kang S, Kwatra SG. 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

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