Galderma’s Phase III OLYMPIA 1 Data Published in JAMA Dermatology Demonstrate That Nemolizumab Improves Core Signs and Symptoms of Prurigo Nodularis

2024年11月29日 15:10:15  [来源:]  [作者:]  [责编:admin]
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Full results from the phase III OLYMPIA 1 trial evaluating the efficacy and safety of nemolizumab in adults with moderate-to-severe prurigo nodularis have been published in JAMA Dermatology, showing the trial met all primary and key secondary endpoints1
Data were consistent with OLYMPIA 2 trial results, reinforcing the potential of nemolizumab monotherapy to demonstrate rapid and sustained improvements in core signs and symptoms of prurigo nodularis: skin lesions, itch and sleep disturbance – at Week 16 and Week 241,2
In the OLYMPIA 1 trial, a significantly higher proportion of nemolizumab-treated patients achieved an itch-free or nearly itch-free state as early as Week 4 compared to those receiving placebo1
Nemolizumab is a first-in-class monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. IL-31 is a neuroimmune cytokine that is known to drive key signs and symptoms of prurigo nodularis3,4

ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SWX:GALD) today announced that full results from the phase III OLYMPIA 1 trial, a 24-week study which evaluated the efficacy and safety of nemolizumab monotherapy in adults with moderate-to-severe prurigo nodularis, were published in JAMA Dermatology.1 The trial met both primary and all key secondary endpoints, showing that nemolizumab-treated patients had significantly higher improvements in itch and skin lesions when compared to those receiving placebo at Week 16, with a rapid and clinically meaningful response on itch and sleep disturbance observed as early as Week 4.1 Nemolizumab was well-tolerated, and its safety profile was generally consistent with previous studies.1

 

“These results, alongside the OLYMPIA 2 trial data, formed the basis of nemolizumab’s recent U.S. Food and Drug Administration approval for the treatment of adults with prurigo nodularis. They demonstrate the potential of this treatment to rapidly and significantly provide relief from the most burdensome symptom for people with prurigo nodularis – itch. We are committed to bringing this treatment option to patients in other parts of the world as soon as possible.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

 

 
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