LAUSANNE, Switzerland -Wednesday 31 October 2018 [ AETOS Wire ]
(BUSINESS
WIRE)-- Galderma, Nestlé Skin Health’s medical solutions business,
today announced positive results from a Phase 2b dose-ranging study of
nemolizumab in adult patients with moderate-to-severe atopic dermatitis
(AD), a serious, chronic form of eczema. Nemolizumab, an investigational
subcutaneous anti-IL-31 receptor A monoclonal antibody, met the primary
endpoint of a greater improvement in Eczema Area and Severity Index
(EASI) scores from baseline compared to placebo, and met secondary
endpoints of major significance to Quality of Life improvement, such as
Peak Pruritus Numerical Rating Scale (NRS) score vs. baseline for
example.
“These
clinical data, coupled with previous phase 2a results from our
licensing partner Chugai, support the growing scientific evidence that
the IL31 pathway may be an important driver in atopic dermatitis. These
results clearly support dose selection and will allow us to pursue the
development as planned. We confirm our intent to progress nemolizumab
into phase 3 in 2019 ” said Thibaud Portal, Ph.D., Vice President of
Galderma’s Prescription business.
Atopic
dermatitis is a chronic inflammatory skin disease, and is the most
common form of eczema which frequently begins in childhood and can last
through adulthood, although in some patients it may start in adulthood.
Moderate-to-severe atopic dermatitis is characterized by an allergic
response driven by a subset of immune cells called Type 2 helper T
cells, or Th2 cells. IL-31, a cytokine released by Th2 cells, is
involved in AD associated pruritus by interacting with IL-31 receptor
alpha expressed by neurons, and is also thought to play a role in AD
skin inflammation and AD skin barrier impairment. Moderate-to-severe
forms of atopic dermatitis can be characterized by pronounced cutaneous
dryness, and skin lesions marked by redness, infiltration/papulation,
crusting/oozing, and lichenification, with periods of lesion
exacerbation accompanied by intense itching, scratching, and skin damage
that can lead to secondary infections. Moderate-to-severe atopic
dermatitis can negatively impact patients’ lives and is associated with a
high burden to patients particularly with itching, sleep deprivation
and depression.
About Nemolizumab
Nemolizumab,
a humanized monoclonal antibody, is directed against the IL-31R alpha,
which blocks IL-31 signaling. Nemolizumab, initially developed by
Chugai, was subsequently licensed to Nestlé Skin Health in 2016.
Nemolizumab is an investigational agent under clinical development and
its safety and efficacy have not been fully evaluated by any regulatory
authority.
About Galderma
Galderma,
Nestlé Skin Health’s medical solutions business, was created in 1981
and is now present in over 100 countries with an extensive product
portfolio to treat a range of dermatological conditions. The company
partners with health care practitioners around the world to meet the
skin health needs of people throughout their lifetime. Galderma is a
leader in research and development of scientifically-defined and
medically-proven solutions for the skin. For more information, please
visit www.galderma.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20181030006192/en/
Contacts
Media
Nestlé Skin Health
Sébastien Cros, Head of Corporate Communications
info@nestleskinhealth.com
Permalink
:
https://www.aetoswire.com/news/galderma-nestleacute-skin-healthrsquos-medical-solutions-business-announces-positive-results-from-phase-2b-study-of-nemolizumab-in-patients-with-moderate-to-severe-atopic-dermatitis/en