LAUSANNE, Switzerland -- (BUSINESS WIRE) --
Galderma, Nestlé Skin Health’s medical solutions business, presented the final results from a Phase 2b dose-ranging study of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 2019 American Academy of Dermatology annual meeting (March 1-5).
Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe AD.
Moderate to severe AD is a serious, chronic form of eczema associated with a high burden of disease linked to itch, sleep deprivation and significant quality of life impairment. This double blind, placebo-controlled, 24 week, dose-ranging Phase 2b study enrolled 226 subjects with moderate-to-severe AD not adequately controlled with topical corticosteroids. All groups received concomitant topical corticotherapy.
This study met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared with placebo. A 73 percent reduction in mean EASI score was observed at Week 24 with nemolizumab compared with 58 percent for placebo.
Nemolizumab was well-tolerated across all dose levels in this trial. The most common adverse events observed were nasopharyngitis and upper respiratory tract infection. Subjects with pre-existing asthma reported an increase in asthma related events; these events were mostly mild and were reversible under treatment.
Nemolizumab-treated subjects showed statistically significant improvements in key secondary efficacy measures compared with placebo after 16 weeks of treatment:
33 percent of nemolizumab-treated subjects achieved clear or almost-clear skin as measured by an investigator’s global assessment (IGA) score of 0 or 1, compared with 12 percent of placebo-treated subjects (p=0.008);
49 percent of nemolizumab-treated subjects achieved 75 percent reduction in EASI score compared with 19 percent of placebo-treated subjects (p<0.01); and
68 percent of nemolizumab-treated subjects achieved at least 4-point reduction in itch, as measured by the pruritus numerical-rating scale (NRS) score, compared with 21 percent reduction in placebo-treated subjects. (p<0.001).
In addition, nemolizumab was associated with a rapid onset of action on AD symptoms: nemolizumab-treated subjects showed early statistically significant improvements in itching and sleep compared with placebo-treated subjects as measured by pruritus NRS and sleep disturbance NRS.
“We are excited by this Phase 2b late-breaking presentation and to be able to report that nemolizumab met all study endpoints in treatment of moderate to severe atopic dermatitis. These new data have added to growing evidence generated with our partner, Chugai, highlighting the importance of the IL-31 pathway as a key driver in moderate to severe atopic dermatitis,” said Thibaud Portal, Ph. D., Global Vice President of Galderma’s Prescription Business.
“The results of this Phase 2b study showed that nemolizumab significantly improved atopic dermatitis signs and very rapidly improved atopic dermatitis symptoms, including pruritus and sleep disturbance. These findings show why nemolizumab is such a promising new investigational drug and how it could be helpful in treating moderate to severe atopic dermatitis,” said Dr. Jonathan I Silverberg, Principal Investigator of the Phase 2b program, from the Department of Dermatology, North Western University, Chicago, IL, USA.
Galderma is now actively preparing for a worldwide Phase 3 pivotal program which will be implemented by mid-2019.
About the IL-31 Pathway and Atopic Dermatitis
Moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema, is a systemic inflammatory disease 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 neuron. IL-31 is also thought to play a role in AD skin inflammation and AD skin barrier impairment. Moderate-to-severe forms of AD 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 AD can negatively impact patients’ lives and is associated with a high burden to patients particularly with itching, sleep deprivation and depression.
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31R alpha, which blocks signaling from both IL-31. 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.
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.
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