Galderma Presented Final Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis at the 2019 American Academy of Dermatology Annual Meeting Late-Breaking Session

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.

About Nemolizumab
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.

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

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