ZUG, Switzerland - Wednesday, 25. September 2024 AETOSWire
New
56-week data from an interim analysis of the phase III ARCADIA
long-term extension study will be presented, with nemolizumab
demonstrating a continuous improvement in clinically meaningful
responses to signs and symptoms of atopic dermatitis for more than one
year1
Novel biomarker data from the phase III ARCADIA study will
also be shared during an oral presentation, with nemolizumab
demonstrating a significant effect on various biomarkers linked to core
features of atopic dermatitis, including itch, skin lesions, and
inflammation2
Data from the OLYMPIA DURABILITY phase IIIb study
demonstrated the clinical benefits of continued use of nemolizumab
beyond 52 weeks in clinically responsive prurigo nodularis patients3
(BUSINESS
WIRE)--Galderma today announced that it will present new data from the
ARCADIA and OLYMPIA clinical trial programs investigating nemolizumab in
atopic dermatitis and prurigo nodularis, respectively, at the 2024
European Academy of Dermatology and Venereology (EADV) congress in
Amsterdam during three separate oral presentations. These late-breaking
data will be presented on Wednesday, September 25, including long-term
efficacy and safety results from an interim analysis of the phase III
ARCADIA long-term extension study and novel biomarker analyses of
nemolizumab in adolescents and adults with moderate-to-severe atopic
dermatitis.1,2 Additionally, encouraging data from the phase IIIb
OLYMPIA DURABILITY study documenting durability of response to
nemolizumab in adults with prurigo nodularis will also be presented.3
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These
new data build on previously published results from the robust phase
III ARCADIA and OLYMPIA clinical trial programs, which demonstrated
nemolizumab’s favorable safety profile and efficacy on itch, skin
lesions and sleep disturbance in atopic dermatitis and prurigo
nodularis, respectively.4-6 Nemolizumab specifically inhibits IL-31
cytokine signaling, which is known to drive key symptoms, such as skin
inflammation, in both of these chronic skin conditions.7,8
“These
late-breaking data further highlight the potential of nemolizumab as an
effective, long-term therapeutic option for patients with atopic
dermatitis and prurigo nodularis seeking relief from itch and skin
lesions. We remain steadfast in our efforts to bring this potential
treatment to patients who need it the most across the world.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA
Interim
results from the ARCADIA long-term extension study at Week 56
demonstrate that continuous nemolizumab treatment leads to clinically
meaningful improvements in skin lesions, itch, sleep, and quality of
life that increase over time in atopic dermatitis
The ARCADIA
long-term extension study enrolled patients from various phase II and
phase III studies, including the pivotal phase III ARCADIA 1 and ARCADIA
2 clinical trials (called lead-in studies), to evaluate the long-term
safety and efficacy of nemolizumab administered with background topical
corticosteroids, with or without topical calcineurin inhibitors, in
adolescents and adults with moderate-to-severe atopic dermatitis, over
four years of treatment.1,9
Results from a 56-week interim
analysis to be presented at EADV 2024 demonstrate that clinically
meaningful improvements in skin lesions continued to increase up to Week
56 for atopic dermatitis patients who were previously exposed to
nemolizumab in the lead-in study, compared to when they entered the
long-term extension study:1
47% of evaluable patients who
were previously exposed to nemolizumab achieved clear or almost clear
skin, as defined by an Investigator’s Global Assessment (IGA) score of 0
or 1, respectively, up from 29%.
73% of evaluable patients who
were previously exposed to nemolizumab achieved a 75% improvement in the
Eczema Area and Severity Index (EASI) score from baseline of their
lead-in study, up from 38%.
The data also demonstrate that
improvements in itch, sleep, and quality of life continued to increase
over time up to Week 56, and that nemolizumab’s safety profile is
consistent with that previously reported in the ARCADIA clinical
trials.1,6
“Many atopic dermatitis patients struggle to
achieve holistic symptom relief with currently available treatments, and
the few that do continue to seek treatments with longevity. These new
data will add to the growing body of evidence demonstrating the
potential long-term benefit of nemolizumab in atopic dermatitis, with
patients seeing improvements in skin lesions, itch, and quality of life
outcomes that continue to increase over time, for more than a year.”
PROFESSOR DIAMANT THAÇI
LEAD INVESTIGATOR OF THE ARCADIA LONG-TERM EXTENSION STUDY
UNIVERSITY OF LUBECK, GERMANY
Additional
late-breaking data from the core phase III ARCADIA clinical trials
demonstrate nemolizumab’s effect on biomarkers that are linked to
features of atopic dermatitis
Novel biomarker data from the phase
III ARCADIA clinical trials will also be presented, substantiating that
targeting of IL-31 signaling with nemolizumab helps to address key
features of atopic dermatitis.2 The data demonstrate that treatment with
nemolizumab results in a significant reduction of various biomarkers
involved in itch, skin lesions, and inflammation, which also correlates
with improvements in clinical outcomes, and that patients with severe
itch show more robust reduction in these biomarkers, indicating that
nemolizumab may hold even greater promise in patients who are most
impacted by this burdensome symptom.2
OLYMPIA DURABILITY study
data demonstrates clinical benefits of continued use of nemolizumab for
more than one year in responsive prurigo nodularis patients
OLYMPIA
DURABILITY is a 24-week phase IIIb withdrawal study conducted in adults
with prurigo nodularis. The study included 34 patients who participated
in the OLYMPIA long-term extension study and achieved a clinical
response, as defined by an IGA score of 0 (clear) or 1 (almost clear)
and an at least four point improvement in weekly average Peak Pruritus
Numerical Rating Scale (PP-NRS) score from baseline of their lead-in
study at Week 52.3,10,11
The study met its primary endpoint;
results to be presented demonstrate that clinically responsive patients
at Week 52 have significantly lower relapse rates (17%) when continuing
nemolizumab therapy than those withdrawn from treatment (75%) after 24
weeks.3 These data support the continued use of nemolizumab beyond 52
weeks for patients who are clinical responders and confirm its long-term
efficacy.3 In the study, relapse was defined as an at least four-point
increase in the PP-NRS score and/or an at least two-point increase in
IGA score from baseline.3
The data also demonstrate that
nemolizumab’s safety profile is consistent with that previously reported
in the OLYMPIA 1 and OLYMPIA 2 pivotal clinical trials.3-5
“People
living with prurigo nodularis suffer from chronic, severe itch, which
disrupts their quality of life, and visible skin lesions, which can
impact their self-confidence. These new long-term data demonstrate that
nemolizumab’s efficacy on itch and skin lesions in prurigo nodularis is
maintained for over one year, and also show that continuous treatment is
necessary to ensure that these burdensome symptoms remain controlled.”
PROFESSOR FRANZ LEGAT
LEAD INVESTIGATOR OF THE OLYMPIA LONG-TERM EXTENSION AND DURABILITY STUDIES
DEPARTMENT OF DERMATOLOGY AND VENEREOLOGY
MEDICAL UNIVERSITY OF GRAZ, GRAZ, AUSTRIA
Media
can find more information about atopic dermatitis and prurigo nodularis
in this media toolkit, and can watch this video to find out more about
the burden of itch for people living with these skin conditions.
About nemolizumab
Nemolizumab
was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016,
Galderma obtained exclusive rights to the development and marketing of
nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab
is marketed as Mitchga® and is approved for the treatment of prurigo
nodularis, as well as pruritus associated with atopic dermatitis in
pediatric, adolescent, and adult patients.12,13
Nemolizumab is
approved in the United States (under the name Nemluvio®) for the
treatment of adults with prurigo nodularis, with the U.S. Food and Drug
Administration’s (FDA’s) decision on atopic dermatitis expected later
this year.14 Galderma’s marketing authorization applications for
nemolizumab in both prurigo nodularis and atopic dermatitis are under
review by multiple regulatory authorities, including the European
Medicines Agency and Health Canada, as well as in Australia, Singapore,
Switzerland, and the United Kingdom, via the Access Consortium
framework.15,16 Further submissions to other regulatory authorities will
continue throughout 2024.
About Galderma
Galderma (SIX:
GALD) is the pure-play dermatology category leader, present in
approximately 90 countries. We deliver an innovative, science-based
portfolio of premium flagship brands and services that span the full
spectrum of the fast-growing dermatology market through Injectable
Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since
our foundation in 1981, we have dedicated our focus and passion to the
human body’s largest organ – the skin – meeting individual consumer and
patient needs with superior outcomes in partnership with healthcare
professionals. Because we understand that the skin we are in shapes our
lives, we are advancing dermatology for every skin story. For more
information: www.galderma.com.
References:
Thaçi D, et
al. Nemolizumab long-term safety and efficacy up to 56 weeks in ARCADIA
open-label extension study in adolescents and adults with
moderate-to-severe atopic dermatitis. Late-breaking abstract presented
at EADV 2024
Guttman-Yassky E, et al. Tape-strips transcriptomic
analysis from patients with moderate to severe atopic dermatitis treated
with nemolizumab. Late-breaking abstract presented at EADV 2024.
Legat FJ, et al. Durability of response to nemolizumab in patients with
moderate-to-severe prurigo nodularis: Results from a randomized
placebo-controlled withdrawal Phase 3b study. Late-breaking abstract
presented at EADV 2024
Ständer S, et al. Nemolizumab monotherapy
improves itch and skin lesions in patients with moderate-to-severe
prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1): Late
breaking abstract presented at EADV 2023
Kwatra SG, et al.
Placebo-controlled phase III trial of nemolizumab in patients with
prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi:
10.1056/NEJMoa2301333
Silverberg JI, et al. Nemolizumab with
concomitant topical therapy in adolescents and adults with
moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from
two replicate, double-blind, randomised controlled phase 3 trials.
Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0
Silverberg JI,
et al. Phase 2B randomized study of nemolizumab in adults with
moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin
Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and
Other Potential Treatments. Dermatol Ther (Heidelb).
2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2
ClinicalTrials.Gov. Long-term Safety and Efficacy of Nemolizumab With
Moderate-to-severe Atopic Dermatitis. Available online. Last accessed
September 2024
ClinicalTrials.Gov. A Long-term Study of
Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN).
Available online. Last accessed September 2024
ClinicalTrials.Gov. A Study to Evaluate the Durability of Response and
Safety of Nemolizumab for 24 Weeks in Participants With Prurigo
Nodularis. Available online. Last accessed September 2024
Chugai
Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for
Mitchga, the first Antibody Targeting IL-31 for Itching Associated with
Atopic Dermatitis. Available online. Last accessed September 2024
Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in
Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous
Injection 30mg Vials. Available online. Last accessed September 2024
Galderma. Galderma receives U.S. FDA approval for Nemluvio®
(nemolizumab) for adult patients living with prurigo nodularis.
Available online. Last accessed: September 2024
Galderma.
Galderma receives filing acceptances for nemolizumab in prurigo
nodularis and atopic dermatitis in four additional countries. Available
online. Last accessed: September 2024
Galderma. Galderma
announces regulatory filing acceptance for nemolizumab in prurigo
nodularis and atopic dermatitis in the U.S. and EU. Available online.
Last accessed: September 2024
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Contacts
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85
Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43
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