- ADESOS Phase 2b study evaluating
orismilast as an oral treatment in 233 patients with
moderate-to-severe atopic dermatitis (AD) has successfully
completed
- Results from the ADESOS study have been selected for an oral
presentation at the late breaking research sessions at the RAVE
Conference 2024
- Orismilast is a next generation, high potency PDE4 B/D
selective inhibitor with reported positive results from a Phase
2b study in psoriasis and Phase 2
study in hidradenitis suppurativa (HS); orismilast is currently
being evaluated in an ongoing IIT study in ulcerative colitis
(UC)
- UNION is progressing orismilast to Phase 3 development in
AD
HELLERUP, Denmark, June 4, 2024 /PRNewswire/ -- UNION therapeutics
A/S (UNION), a privately held, clinical stage, pharmaceutical
development company focused on immunology, today announces
successful completion of the ADESOS Phase 2b, randomized, dose-finding study evaluating
orismilast as an oral treatment in 233 patients with
moderate-to-severe AD.
Topline results from the ADESOS study have been selected for an
oral presentation by the Signatory Investigator, Professor
Jonathan Silverberg, MD, PhD, MPH at
the late breaking research sessions at Revolutionizing Alopecia
Areata, Vitiligo, and Eczema (RAVE) Conference on June 8-10, 2024, in Chicago, United
States. It will be the first presentation of data from the
ADESOS study.
Presentation details
Presentation: Efficacy and safety of orismilast, a potent
PDE4B/D inhibitor, in adults with moderate-to-severe atopic
dermatitis: a Phase 2b randomized,
double-blind, placebo-controlled clinical trial (ADESOS)
Presenter: Jonathan Silverberg, MD, PhD, MPH, Professor of
Dermatology at The George Washington
University School of Medicine and Health Sciences and
Signatory Investigator for ADESOS
Date and time: Monday June 10, 2024, at 1:30 PM - 4:40 PM CDT.
Jonathan Silverberg, MD, PhD,
MPH, Professor of Dermatology at The George
Washington University School of Medicine and Health
Sciences and Signatory Investigator for ADESOS study,
said:
"AD is one of the most common chronic inflammatory skin
diseases worldwide. Innovation in recent years has brought good
injectable treatments to patients, but a significant unmet medical
need for a safe and effective oral treatment still exists.
Orismilast offers the potential for a safe oral treatment with
early itch reduction and holds a significant promise as a novel
treatment option in AD."
Kim Kjøller, Co-Chief Executive Officer of UNION
therapeutics, adds:
"The results from the ADESOS study with orismilast in atopic
dermatitis (AD) follows positive read outs in psoriasis and
hidradenitis suppurativa (HS) confirming the potential of
orismilast as a safe oral treatment across immunology. We are
pleased that the Phase 2b results
from the ADESOS study have been selected for an oral presentation
at the RAVE Conference in Chicago
and look forward to the results being shared and discussed with the
leading experts in the field."
Orismilast is developed as a next-generation, high potency
PDE4B/D selective inhibitor targeting first-in-class positions in
AD and hidradenitis suppurativa (HS), and best in class in
psoriasis. The efficacy and safety profile of orismilast have been
evaluated in the previously reported IASOS Phase 2b study in psoriasis and OSIRIS Phase 2 study in
HS. Data of these studies has been presented at leading scientific
conferences and data is published in peer-reviewed journals,
including the Journal of American Academy of Dermatology (JAAD) and
the Journal of European Academy of Dermatology and Venerology
(JEADV).
UNION has scheduled an End of Phase 2 meeting with the FDA to
discuss advancing the orismilast development program into Phase 3
studies in AD.
About the ADESOS Phase 2b
study
The Phase 2b study was a
randomized, double-blind, placebo-controlled, parallel-group,
dose-finding study to evaluate the efficacy and safety of
orismilast in patients with moderate to severe AD. The study
included 233 patients who were randomized to three active
doses (20mg, 30mg, and 40 mg) of orismilast or placebo
administered twice daily. The study was conducted in centers in
Europe and in the US.
About orismilast
Orismilast is a next generation, high potency PDE4 inhibitor
targeting the PDE4B/D subtypes linked to inflammation,
demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It
acts early in the inflammation cascade, inducing a broad range of
anti-inflammatory effects across multiple cytokines involved
in many dermatological and immunological
diseases.1)
UNION is developing orismilast as an oral treatment, based on
the well-known safety profile of the PDE4 class, across immunology,
initially targeting best-in-class or first-in-class positions in
atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis
and ulcerative colitis (UC).
The FDA has cleared UNION's Investigational New Drug (IND)
application for orismilast and granted Fast Track designation for
orismilast for the treatment of moderate to severe AD as well as
for the treatment of moderate to severe HS.
About atopic dermatitis
AD is a chronic inflammatory skin disease affecting 2.1-4.9 % of
the adult population worldwide and is the most common skin disease
among children.2) There were approximately 20 million
diagnosed moderate-to-severe adult patients with AD in 2023 in the
Seven Major Markets (United
States, France, Germany, Italy, Spain, UK,
and Japan).3) Disease symptoms are characterized by
recurrent eczematous skin lesions and intense itch. AD has a
substantial psychosocial impact on patients and
relatives.4) During disease flares, approximately
80% of patients may experience disturbed sleep, which may also
disrupt the sleep of family members.5) The disease
also appears to impact the mood and patients have an increased risk
of anxiety and depression.6)
Sources
1) Blauvelt A et al.,
Dermatology and Therapy 2023: Next Generation PDE4 Inhibitors that
Selectively Target PDE4B/D Subtypes: A Narrative Review - PubMed
(nih.gov) &
Silverberg J.I. et al., JEADV 2022:
https://onlinelibrary.wiley.com/doi/10.1111/jdv.18818
&
Warren R.B. et al., JEADV 2022:
https://onlinelibrary.wiley.com/doi/10.1111/jdv.18812
2) Barbarot S et al,.
Allergy 2018: https://pubmed.ncbi.nlm.nih.gov/29319189/
https://pubmed.ncbi.nlm.nih.gov/25925336/
3) EvaluatePharma 2023
4) Laughter MR et al.,
British Journal of Dermatology 2021:
https://pubmed.ncbi.nlm.nih.gov/33006135/
5) Eichenfield LF et al.,
Journal of the American Academy of Dermatology 2014:
https://pubmed.ncbi.nlm.nih.gov/24290431/
6) Drucker AM et al., The
Journal of Investigative Dermatology 2017:
https://pubmed.ncbi.nlm.nih.gov/27616422/
Contacts
Morten Boesen, Chief Financial
Officer, UNION therapeutics A/S
+45 2381 5487
morten.boesen@uniontherapeutics.com
Sarah Toft-Jørgensen, Director of Communications and IR, UNION
therapeutics A/S
+45 5385 3044
sarah.toft-joergensen@uniontherapeutics.com
About UNION therapeutics
UNION therapeutics is a privately held, clinical stage,
pharmaceutical development company focused on immunology. UNION is
headquartered in Hellerup, Denmark, and led by an international team
combining biotech entrepreneurs and seasoned pharma executives,
with a track record of developing and launching more than fifteen
marketed drugs. Read more at www.uniontherapeutics.com
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