LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting
March 18 2023 - 04:10PM
Business Wire
- Results presented at AAD 2023 demonstrated that investigational
agent LEO 138559 met its primary endpoint of change in the Eczema
Area and Severity Index (EASI) compared with placebo1
- Efficacy analysis showed significant improvement versus placebo
across a variety of endpoints including EASI-75, EASI-90, and
EASI-100, in adult patients with moderate-to-severe atopic
dermatitis1
- These results are the first to be presented for an IL-22
receptor targeting antibody for the treatment of moderate-to-severe
atopic dermatitis1
LEO Pharma A/S, a global leader in medical dermatology, today
announced that a Phase 2a trial evaluating the efficacy and safety
of investigational agent LEO 138559 in adults with
moderate-to-severe atopic dermatitis met its primary endpoint.
Results were shared as one of two LEO Pharma late breaker oral
presentations at the 2023 American Academy of Dermatology (AAD)
Annual Meeting.1 LEO 138559 is an investigational agent and its
efficacy and safety are subject to further larger trials.
LEO 138559 is an investigational monoclonal antibody currently
in Phase 2 development for the treatment of moderate-to-severe
atopic dermatitis, which blocks the IL-22RA1 receptor subunit
thereby inhibiting the effect of the interleukin-22 (IL-22)
cytokine – known to be elevated in patients with atopic
dermatitis.1–3 LEO 138559 potentially also inhibits to some extent
the effects of cytokines IL-20 and IL-24; however, this remains to
be fully understood.1
“We know that atopic dermatitis is a complex immunological
condition and LEO Pharma is committed to supporting patients and
clinicians in dermatology by finding new ways to treat this chronic
disease,” said J�rg M�ller, Executive Vice President, Global
Research and Development, LEO Pharma. “We are encouraged by these
Phase 2a results, in moderate-to-severe atopic dermatitis and plans
are underway for a Phase 2b trial.”
The results from the Phase 2a trial in 58 adult patients showed
that LEO 138559 dosed at 450 mg every other week (Q2W) via
subcutaneous injections for 16 weeks had a favourable safety
profile.1 LEO 138559 demonstrated significant improvement compared
with placebo in the primary endpoint of change in EASI score from
baseline (-15.3 vs. -3.5) and across a range of endpoints including
EASI-75 (41.6% vs.13.7%), EASI-90 (30.8% vs. 3.5%), EASI-100 (20.9%
vs. 0%) and vIGA-AD 0/1 (27.3% vs. 7.0%).1 The most frequently
reported AEs in the LEO 138559 versus placebo arms were COVID-19
(13.8% vs 6.9%), dermatitis atopic (13.8% vs 13.8%), and upper
respiratory tract infection (3.4% vs 10.3%).1
“These results are promising, as they demonstrate for the first
time the potential benefits of targeting the IL-22 receptor which
is a new mode of action”, said Professor Diamant Thaci, MD, Head of
Institute and Comprehensive Center for Inflammation Medicine,
University of Lübeck, Lübeck, Germany and the international
coordinating investigator for the Phase 2a trial. “Patients with
moderate-to-severe atopic dermatitis still face numerous unmet
needs and we welcome any new advances that could provide us with
additional options to help them.”
LEO Pharma and argenx BV formed a strategic alliance in 2015 to
develop innovative antibody-based solutions for the treatment of
chronic inflammation that underlies many skin conditions. LEO
Pharma and argenx BV jointly developed LEO 138559 under an
exclusive option and research agreement. LEO Pharma obtained the
license to LEO 138559 in 2022 and now assumes the responsibility to
develop and commercialize LEO 138559 for inflammatory skin
disorders, such as atopic dermatitis.
The collaboration between LEO Pharma and argenx BV stands as a
strong example of an external innovation sourcing model, which is a
key pillar in LEO Pharma’s new Research and Development
strategy.
About the Phase 2a trial
The LEO 138559 Phase 2a trial (NCT04922021) was a randomized,
double-blind, placebo-controlled, multi-site, trial to evaluate the
efficacy and safety of LEO 138559 in adult patients with
moderate-to-severe atopic dermatitis. Patients were randomized 1:1
(n=29 per arm) to receive either LEO 138559 dosed at 450 mg Q2W or
placebo, for 16 weeks. The primary endpoint was change in EASI
score from baseline to Week 16.1 Other endpoints included EASI-75,
EASI-90, EASI-100 (which represent a 75, 90 and 100 percent
improvement in atopic dermatitis area and severity) and vIGA-AD 0/1
(proportion of patients who achieved ‘clear’ or ‘almost clear’
skin).1
About atopic dermatitis
Atopic dermatitis is a chronic, inflammatory skin disease
characterized by intense itch and eczematous lesions.4 Atopic
dermatitis is the result of skin barrier dysfunction and immune
dysregulation, leading to chronic inflammation.5
About investigational LEO 138559
LEO 138559 is an investigational monoclonal antibody that
targets the IL-22RA1 receptor subunit, currently in Phase 2
development for the potential treatment of moderate-to-severe
atopic dermatitis.1 It blocks the IL-22RA1 subunit and thereby
inhibits the effects of the IL-22 cytokine, and potentially also to
some extent the effects of IL-20 and IL-24.1 LEO 138559 does not
bind to the IL-22 cytokine itself.1 LEO Pharma has obtained a
worldwide exclusive license to develop and commercialize LEO 138559
from argenx BV.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the
standard of care for the benefit of people with skin conditions,
their families and society. Founded in 1908 and majority owned by
the LEO Foundation, LEO Pharma has devoted decades of research and
development to advance the science of dermatology, and today, the
company offers a wide range of therapies for all disease
severities. LEO Pharma is headquartered in Denmark with a global
team of 4,700 people, serving millions of patients across the
world. In 2022, the company generated net sales of DKK 10.6
billion. Learn more at www.leo-pharma.com.
About argenx BV
argenx BV is a global immunology company committed to improving
the lives of people suffering from severe autoimmune diseases. For
more information, visit www.argenx.com
References
- Thaci D, et al. Presented at American Academy of Dermatology
(AAD) 2023 Annual Meeting, New Orleans, March 17–21 2023.
- Fujita H. J Dermatol Sci 2013;72:3–8.
- Czarnowicki T, et al. J Allergy Clin Immunol
2019;143:1–11.
- Weidinger S, et al. Lancet 2016;387:1109–1122.
- Boguniewicz M, et al. Immunol Rev 2011;242:233–246
MAT-64076 March 2023
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Henrik Heskjaer Global External Communications +45 3140 6180
hdtdk@leo-pharma.com
Jes Frederiksen Global Corporate Affairs +45 53 60 59 48
jebfe@leo-pharma.com