RARE Daily

Galderma Reports Positive Results from Mid-Stage Study of Therapy for Rare Skin Condition

February 24, 2020

Rare Daily Staff

Galderma reported positive results, published in The New England Journal of Medicine, from a phase 2 study of experimental therapy nemolizumab in adult patients suffering from moderate-to-severe prurigo nodularis, a rare skin condition.

Prurigo nodularis (PN) is a rare, potentially debilitating, chronic condition that causes thick skin nodules to cover large body areas and associated severe itchiness known as pruritus. It frequently leads to severe quality of life impairment. Nemolizumab is a first-in-class experimental monoclonal antibody that blocks signaling of IL-31, which plays a key role in the pathogenesis of PN.

In the phase 2 randomized clinical trial of 70 patients with moderate to severe PN and severe pruritus, nemolizumab met the primary endpoint of a greater improvement in Peak Pruritus Numerical rating scale (PP-NRS) from baseline to week 4 compared to placebo. The baseline PP-NRS was 8.4 in both groups. At week 4, in the nemolizumab arm PP-NRS was reduced from baseline by 53 percent compared to 20.2 percent in placebo. All the other measures showed a significant difference in patients taking nemolizumab. At week 18 (10 weeks after the last dose), 38 percent of the patients who received nemolizumab were clear or almost clear of PN compared to 6 percent of the patients who received placebo. Nemolizumab was well tolerated and no imbalance in adverse events was observed between the two groups.

“Prurigo nodularis is known to have a profoundly negative impact on quality of life of patients, and despite significant unmet needs, there are currently no approved therapeutic options,” said Thibaud Portal, global head of Prescription medicines at Galderma. “The phase 2 study results indicate that nemolizumab may have a key role to play for patients with moderate to severe prurigo nodularis.”

In November 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to nemolizumab for the treatment of pruritus associated with PN. Galderma is planning to initiate a phase 3 pivotal program with nemolizumab in adult patients with PN this year.


Photo: Thibaud Portal, global head of prescription medicines at Galderma





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