Galderma’s nemolizumab sets new standard in prurigo nodularis treatment with OLYMPIA 1 trial success

Galderma’s latest clinical trial has unveiled a significant breakthrough in treating prurigo nodularis, a chronic neuroimmune skin condition characterized by relentless itching and thickened skin nodules. The Phase III OLYMPIA 1 trial results, now published in JAMA Dermatology, confirm that nemolizumab, a monoclonal antibody developed by Galderma, delivers rapid and sustained symptom relief, achieving significant improvements as early as four weeks into treatment.

The trial, which enrolled 286 adults with moderate-to-severe prurigo nodularis, met all its primary and key secondary endpoints. Nemolizumab-treated patients experienced notable reductions in itch intensity, skin lesion severity, and sleep disturbances compared to placebo, showcasing its potential as a transformative monotherapy for this debilitating condition.

Data reinforces nemolizumab’s efficacy

According to the trial findings, over 58% of patients treated with nemolizumab achieved a reduction of at least four points in itch intensity on the peak-pruritus numerical rating scale (PP-NRS) by Week 16. In contrast, just 16.7% of patients in the placebo group reached the same benchmark. Furthermore, more than 26% of nemolizumab users achieved near or complete skin lesion clearance, a marked improvement compared to 7.3% of placebo recipients.

Significant progress was evident as early as Week 4, with 41% of nemolizumab patients reporting substantial itch relief and improved sleep quality, outcomes that continued to improve through the 24-week trial period.

Groundbreaking approach to prurigo nodularis

Nemolizumab’s innovative mechanism of action sets it apart from traditional therapies. By targeting the IL-31 receptor alpha, the drug interrupts IL-31 signaling, a key pathway driving the intense itch and skin abnormalities associated with prurigo nodularis. This neuroimmune cytokine has long been identified as a critical contributor to the condition, making nemolizumab the first approved treatment to directly address these mechanisms.

Expert perspectives on patient impact

Galderma’s Global Head of R&D, Dr. Baldo Scassellati Sforzolini, highlighted that the OLYMPIA 1 trial results, alongside findings from the earlier OLYMPIA 2 trial, underpin the recent U.S. Food and Drug Administration (FDA) approval of nemolizumab under the brand name Nemluvio®. He expressed optimism about the drug’s potential to improve the lives of patients worldwide as regulatory reviews progress in regions such as Europe, Australia, and South Korea.

Professor Sonja Ständer, lead investigator from University Hospital Münster, emphasized the significance of nemolizumab’s ability to alleviate chronic itch, improve skin health, and enhance sleep quality. She noted that these improvements address symptoms that often undermine patients’ mental health and overall quality of life.

A new era for prurigo nodularis treatment

With prurigo nodularis affecting an estimated 181,000 people in the United States alone, the condition remains underdiagnosed and undertreated. Patients frequently report that persistent itching disrupts their sleep and negatively impacts daily activities and mental well-being. Nemolizumab’s approval offers new hope, providing a targeted solution for a disease that has long lacked effective treatment options.

Beyond prurigo nodularis

The success of nemolizumab in the OLYMPIA 1 trial is paving the way for broader applications. Galderma has submitted additional marketing applications for the treatment of atopic dermatitis in both adults and adolescents, with a decision on its Biologics License Application expected by the end of the year.