Baldo Scassellati Sforzolini, MD, PhD, MBA: Expanding Nemolizumab’s Access

Earlier this month, Galderma announced that it received filing acceptances for nemolizumab for the treatment of prurigo nodularis and moderate to severe atopic dermatitis in 4 additional countries, including Australia, Singapore, Switzerland, and the United Kingdom. The regulatory authorities of Australia, Singapore, Switzerland, and the United Kingdom are members of the Access Consortium and an approval decision from the consortium is expected in 2025.¹

The US Food and Drug Administration (FDA) and the European Medicines Agency accepted filing submissions for nemolizumab in February 2024. The FDA’s US decision is expected in 2024. Additionally, the FDA granted nemolizumab Priority Review for prurigo nodularis.²

The regulatory submissions of nemolizumab in prurigo nodularis are based on data from the phase 3 OLYMPIA clinical trial program, which evaluated the efficacy and safety of nemolizumab administered subcutaneously every 4 weeks in patients with prurigo nodularis. In the OLYMPIA program, patients treated with nemolizumab monotherapy showed clinically and statistically significant improvements in both primary end points compared to placebo after 16 weeks of treatment.²

To further discuss the significance of additional regulatory filing acceptances of nemolizumab for prurigo nodularis, Dermatology Times spoke to Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma.

Q&A With Baldo Scassellati Sforzolini, MD, PhD, MBA

Baldo Scassellati Sforzolini, MD, PhD, MBA

Image credit: Galderma

Dermatology Times: Nemolizumab has the potential to become a first-line treatment for much-needed relief of prurigo nodularis. What makes nemolizumab’s mechanism of action unique?

Scassellati Sforzolini: Nemolizumab specifically inhibits interleukin-31 (IL-31) cytokine signaling by targeting the IL-31 receptor alpha. By targeting and blocking this neuroimmune cytokine signaling, which drives key symptoms of prurigo nodularis, nemolizumab has the potential to rapidly and effectively address the most burdensome symptom for people with prurigo nodularis – itch, as well as the appearance of skin nodules.

Dermatology Times: In your opinion, what is the significance of nemolizumab for PN recently receiving filing acceptances in 4 additional countries outside of the US within months of the US acceptance?

Scassellati Sforzolini: Despite the significant burden of prurigo nodularis, there is only one approved treatment option for people diagnosed with this condition. The filing acceptances in these additional countries are a step towards bringing nemolizumab to patients in these countries, who are in need of alternative therapeutic options that act on itch and skin nodules to treat prurigo nodularis. The fact that this milestone came within months of the US Food and Drug Administration and European Medicines Agency also accepting filing submissions in both prurigo nodularis and atopic dermatitis shows how Galderma is committed to ensuring rapid access to nemolizumab in many countries around the world.

Dermatology Times: What key data points are most important for dermatology clinicians to keep in mind regarding the phase 3 OLYMPIA trials that the regulatory submissions are based on?

Scassellati Sforzolini: Over 50% of nemolizumab-treated patients achieved a significant reduction in itch intensity and sleep disturbance at week 16, with over 40% seeing an improvement in itch within 4 weeks. Additionally, more than three times as many patients treated with nemolizumab reached clearance or almost-clearance of skin lesions, compared to placebo at week 16.

Supporting data:

• 58% and 56% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, achieved an at least 4-point reduction in itch intensity at week 16, as measured by the peak-pruritus numerical rating scale, compared to 17% and 21% in the placebo group (p<0.001).
• 41% of nemolizumab-treated patients in OLYMPIA 1 and 2, achieved an at least 4-point reduction in itch intensity at week 4, as measured by the peak-pruritus numerical rating scale, compared to 6% and 7% in the placebo group (p<0.001).
• 26% and 38% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, reached clearance (investigator’s global assessment (IGA) 0) or almost-clearance (IGA 1) of skin lesions at week 16, when assessed using the IGA score (range: 0-4), compared to 7% and 11% in the placebo group (p<0.001).
• 50% and 52% of nemolizumab-treated patients in OLYMPIA 1 and 2, respectively, achieved an at least four-point reduction in sleep disturbance at week 16, as measured by the sleep disturbance numerical rating scale, compared to 12% and 21% in the placebo group (p<0.001).

Dermatology Times: In your opinion, how will nemolizumab change the way dermatology clinicians are able to address the physical and mental burden of PN in their patients?

Scassellati Sforzolini: Itch is the most burdensome symptom for people with prurigo nodularis. The relentless itch can make it difficult to concentrate and sleep, which can have a significant impact on quality of life. Patients also report that having firm skin nodules on visible body areas really impacts their confidence and means they don’t feel comfortable in social settings. We’ve seen in the OLYMPIA trials that nemolizumab can significantly improve these three key areas that contribute to the physical and mental burden of the disease – itch, sleep disturbance, and skin lesions.

Closing thoughts

Scassellati Sforzolini: In addition to these 4 countries, nemolizumab is also under review for the treatment of prurigo nodularis and moderate to severe atopic dermatitis by the US Food and Drug Administration and European Medicines Agency. With the first regulatory decisions expected later this year, we hope to bring this treatment option to patients with prurigo nodularis, as well as atopic dermatitis, who equally suffer from impaired quality of life from their disease, as soon as possible to help alleviate the significant burden they face.

Baldo Scassellati Sforzolini, MD, PhD, MBA, is the global head of research & development at Galderma. He holds an MD from the University of Bologna, a PhD in neurosensory science and ophthalmology residency from the Marche Polytechnic University, a diploma of Pharmaceutical Medicine from Cardiff University, and an MBA from Cranfield School of Management.

References

1. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. News release. Galderma. May 7, 2024. Accessed May 17, 2024. https://www.galderma.com/news/galderma-receives-filing-acceptances-nemolizumab-prurigo-nodularis-and-atopic-dermatitis-four
2. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. News release. Galderma. February 14, 2024. Accessed May 17, 2024. https://www.galderma.com/news/galderma-announces-regulatory-filing-acceptance-nemolizumab-prurigo-nodularis-and-atopic