Galderma recently announced that the full results from the Phase III OLYMPIA 1 trial, which evaluated the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis, were published in JAMA Dermatology. The data from this trial, in conjunction with the results from the OLYMPIA 2 trial, were pivotal in securing the U.S. Food and Drug Administration (FDA) approval for nemolizumab (marketed as Nemluvio®) as a treatment for prurigo nodularis in adults. This milestone highlights the potential of nemolizumab to provide rapid and significant relief from one of the most debilitating symptoms of prurigo nodularis – chronic, intense itch.
Dr. Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, emphasized that these results underscore the treatment’s capacity to offer quick and meaningful relief from itch, a symptom that greatly impacts patients’ quality of life. “We are committed to bringing this treatment option to patients worldwide as soon as possible,” he added. The results from the OLYMPIA 1 trial serve as a key foundation for further advancing this treatment globally.
OLYMPIA 1 Trial Design and Results
The OLYMPIA 1 trial was a randomized, double-blind, placebo-controlled Phase III study conducted over 24 weeks. It included 286 adult patients diagnosed with moderate-to-severe prurigo nodularis. The trial specifically tested the effects of nemolizumab monotherapy, meaning that patients did not use any background treatments such as topical corticosteroids or calcineurin inhibitors.
The study demonstrated that nemolizumab treatment led to significant improvements in both the primary and secondary endpoints. After 16 weeks of treatment, patients receiving nemolizumab showed improvements more than three times greater than those in the placebo group. For instance, 58.4% of nemolizumab-treated patients achieved at least a four-point improvement in itch intensity, measured by the peak-pruritus numerical rating scale (PP-NRS), compared to just 16.7% in the placebo group (P<0.001). Additionally, 26.3% of patients treated with nemolizumab achieved complete or near-complete clearance of skin lesions, compared to only 7.3% of the placebo group (P<0.01).
These findings were particularly notable because they demonstrate a clinically meaningful response, particularly in terms of itch, which is one of the most burdensome symptoms for individuals with prurigo nodularis.
Secondary Endpoints and Early Responses
The trial also met all key secondary endpoints, confirming that the benefits of nemolizumab were evident as early as Week 4. Patients receiving nemolizumab showed rapid improvements in itch and sleep disturbance, with these improvements continuing to increase throughout the trial period.
Specifically, 41.1% of patients in the nemolizumab group achieved a reduction of at least four points in their PP-NRS score, compared to just 6.3% in the placebo group (P<0.001). Furthermore, more than twenty times as many nemolizumab-treated patients (21.6%) achieved a PP-NRS score of less than 2, compared to only 1.0% of patients in the placebo group (P<0.001). By Week 16, this number had risen to 34.2% in the nemolizumab group versus just 4.2% in the placebo group (P<0.001).
In terms of sleep disturbance, a significant improvement was observed in 50.0% of patients treated with nemolizumab, who showed a four-point improvement on the sleep disturbance numerical rating scale (SD-NRS), compared to 11.5% of the placebo group (P<0.001). These improvements also persisted through to Week 16 (50.0% vs 11.5%; P<0.001), further emphasizing the treatment’s effectiveness in managing both itch and its secondary effects on sleep.
Reinforcing Evidence from OLYMPIA 2 Trial
The results from the OLYMPIA 1 trial further corroborate the findings from the OLYMPIA 2 trial, which was published in The New England Journal of Medicine. Both trials demonstrated that nemolizumab provides rapid and clinically meaningful improvements in both itch and skin lesions, with some patients reporting noticeable benefits as early as Week 4.
The OLYMPIA trial program is notable for being the largest Phase III study conducted on prurigo nodularis to date, and it includes an open-label, long-term extension study that will continue to provide valuable insights into the sustained effects of nemolizumab.
Expert Commentary
Professor Sonja Ständer, the lead investigator of the OLYMPIA trials and Professor of Dermatology at the University Hospital Münster in Germany, remarked on the significance of the full OLYMPIA 1 results. She highlighted that the data further supports nemolizumab’s potential to offer significant improvements in managing the most debilitating symptoms of prurigo nodularis, including chronic itch, skin nodules, and disrupted sleep. These symptoms can be overwhelming and often have a profound impact on patients’ overall quality of life and mental health.
Regulatory Approvals and Global Expansion
Based on the data from the OLYMPIA clinical trials, the FDA approved nemolizumab for the treatment of adults with prurigo nodularis under the brand name Nemluvio® in August 2024. Additionally, Galderma has submitted marketing authorization applications for nemolizumab in multiple other regions, including the European Medicines Agency, as well as countries within the Access Consortium framework, such as Australia, Singapore, and Switzerland. Regulatory submissions are also underway in other markets, including Canada, Brazil, and South Korea.
Understanding Prurigo Nodularis
Prurigo nodularis is a chronic, debilitating skin disease characterized by severe itch and the development of thick, raised skin nodules, often covering large areas of the body. It is considered an underrecognized and underdiagnosed condition, with estimates suggesting that up to 181,000 people in the United States live with prurigo nodularis. The constant itch associated with the condition can significantly affect a patient’s quality of life, leading to sleep disturbances, depression, and anxiety. The intense itching and skin changes associated with prurigo nodularis make it a particularly challenging condition to manage, emphasizing the importance of effective treatments like nemolizumab.
About Nemolizumab
Nemolizumab is a monoclonal antibody developed by Galderma and is the first FDA-approved treatment to specifically target the signaling of IL-31, a neuroimmune cytokine that plays a key role in driving the pathogenesis of prurigo nodularis. By inhibiting this cytokine, nemolizumab effectively reduces the intensity of itch and improves skin lesions. In addition to its approval for prurigo nodularis, Galderma has also submitted a Biologics License Application (BLA) for the use of nemolizumab in moderate-to-severe atopic dermatitis, with a decision expected by the end of 2024.
Initially developed by Chugai Pharmaceutical Co., Ltd., nemolizumab was licensed to Galderma in 2016, excluding Japan and Taiwan. In Japan, the drug is marketed under the name Mitchga® and is approved for prurigo nodularis and pruritus associated with atopic dermatitis in both pediatric and adult patients.
About the OLYMPIA 1 Trial
OLYMPIA 1 was a Phase III, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis over a 24-week period. The trial included 286 participants and aimed to assess improvements in both the primary endpoints of itch and skin lesions, as well as secondary endpoints related to sleep disturbance.
About Galderma
Galderma (SIX: GALD) is a global leader in dermatology, present in approximately 90 countries. The company focuses on developing innovative, science-based products across a range of dermatological conditions, offering a diverse portfolio that spans dermatological skincare, therapeutic dermatology, and injectable aesthetics. Since its founding in 1981, Galderma has dedicated its efforts to advancing the science of dermatology and meeting the needs of both patients and healthcare professionals worldwide.
