Shots:
- Recently, the groundbreaking results from Galderma’s Phase III OLYMPIA 1 trial were published in JAMA Dermatology. The study evaluated nemolizumab in patients with moderate-to-severe active prurigo nodularis
- The trial met all primary and secondary endpoints, with results aligning with those from the OLYMPIA 2 trial, reinforcing nemolizumab’s potential in achieving sustained improvements in the core signs and symptoms of prurigo nodularis
- Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, highlighted the findings and discussed the therapeutic potential of nemolizumab for conditions linked to IL-31 signaling.
Saurabh: Would you elaborate on the study design of OLYMPIA 1?
Baldo: OLYMPIA 1 was a phase III, randomized, double-blind, placebo-controlled clinical trial, which assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in people at least 18 years old with moderate-to-severe prurigo nodularis. 286 patients took part in the trial, which had a 24-week treatment period.
OLYMPIA 1 is part of our OLYMPIA clinical trial program, which also includes the identically designed OLYMPIA 2 pivotal trial.
Saurabh: What primary and secondary endpoints did you target in patients participating in OLYMPIA 1?
Baldo: The OLYMPIA 1 pivotal trial had two primary endpoints: the proportion of nemolizumab-treated patients who reached clearance or almost-clearance of skin lesions and the proportion of patients who achieved at least a four-point reduction in itch intensity at Week 16 compared to placebo (measured by the investigator’s global assessment score and peak-pruritus numerical rating scale (PP-NRS), respectively).
The key secondary endpoints were the proportion of nemolizumab-treated patients who reached an at least four-point improvement from their baseline at Week 4 as measured by the PP-NRS and the proportion of patients who achieved an at least four-point improvement from their baseline as measured by the sleep disturbance numeric rating scale at Week 16 and at Week 4.
There were additional secondary endpoints including the number of patients who experienced an adverse event.
Saurabh: How has Nemolizumab improved the standard of treatment for patients suffering from Prurigo Nodularis?
Baldo: The debilitating symptoms associated with prurigo nodularis skin lesions, including chronic itch and poor sleep quality, place a huge burden on people who live with this condition, as well as those around them. These symptoms are often managed with systemic or topical treatments, which do not address the underlying pathophysiology of the disease, which means they have limited efficacy, and they also carry the risk of adverse effects. Therefore, there is a need for alternative treatment options that could effectively relieve the signs and symptoms of prurigo nodularis.
Nemolizumab is a monoclonal antibody that inhibits the signaling of a neuroimmune cytokine (IL-31) that drives key signs and symptoms of prurigo nodularis. The results from Galderma’s pivotal OLYMPIA 1 and OLYMPIA 2 trials demonstrate its potential to provide rapid and sustained improvements in skin lesions, itch and sleep disturbance. Following these results and its approval in the U.S. for prurigo nodularis back in August 2024, we’re confident in the impact this treatment will have for patients with prurigo nodularis, who urgently need more treatment options and are in desperate need of relief from the most burdensome symptom – itch.
Saurabh: Can you give us an insight into the safety and tolerability of Nemolizumab?
Baldo: Data from the OLYMPIA clinical trial program has shown that nemolizumab was well tolerated and its safety profile was generally consistent with its phase II trial and between the OLYMPIA 1 and 2 trials.
Saurabh: Nemolizumab is under regulatory review to treat adults and adolescents with moderate to severe Atopic Dermatitis. Are there other indications associated with itch or IL-31 signaling for which Nemolizumab is under investigation?
Baldo: Nemolizumab was approved by the U.S. Food and Drug Administration (FDA) for the treatment of prurigo nodularis in adults in August 2024, under the name Nemluvio®. Galderma has not received approval for nemolizumab in any other jurisdiction for any other indication. Galderma has also submitted a Biologics License Application/filing application for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis to the U.S. FDA, and for the treatment of both prurigo nodularis and atopic dermatitis to the European Medicines Agency and numerous other regulatory authorities across the world.
Galderma has identified other new potential indications for nemolizumab that are currently under assessment for clinical development.
Saurabh: Is Nemolizumab under investigation with background topical corticosteroids or calcineurin inhibitors to improve patient care? If not, is there a possibility of investigation of combination therapies to reform treatment options?
Baldo: In prurigo nodularis, nemolizumab was successfully investigated and approved in the U.S. as a monotherapy. In atopic dermatitis, the ARCADIA clinical trial program investigated nemolizumab administered with background topical corticosteroids with or without topical calcineurin inhibitors (+TCS/TCI) which better reflects how systemic treatments are used in real life. The results of the pivotal ARCADIA trials demonstrate that nemolizumab +TCS/TCI has the potential to be an effective and convenient treatment for people suffering from moderate-to-severe atopic dermatitis.
Saurabh: What is the significance of sleep disturbance as a secondary endpoint during this trial?
Baldo: Many people with prurigo nodularis experience sleep disturbance due to intense itch, which often has a considerable impact on patients’ quality of life. Studies have shown that up to 30% of patients with prurigo nodularis report sleep improvement as a key treatment goal.
In the OLYMPIA 1 trial, almost six times as many people treated with nemolizumab demonstrated a four-point improvement in sleep disturbance compared with placebo as early as Week 4, with results continuing to improve through to Week 16. These results show nemolizumab’s potential to make a meaningful and positive impact for patients and their quality of life.
Image Source: Canva
About the Author:
Baldo Scassellati Sforzolini
Baldo Scassellati Sforzolini is Global Head of Research & Development at Galderma since July 2020. Baldo joined Galderma from Allergan where he was Senior Vice President, Drug Development Operations and Global Evidence & Value. Prior to this, he served as Allergan’s Senior Vice President, Clinical Development, Vice President and Head of Global Development at Bausch + Lomb, and Vice President Ophthalmology Development at Novartis. He has also held positions in global development at Pfizer and Pharmacia. Baldo 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.
Related Post: Infusing Automation: Suresh Kannan from Model N in an Illuminating Discussion with PharmaShots
