UNION therapeutics announces enrollment of the first patient in ADESOS Phase 2b study of orismilast MR tablet in patients with atopic dermatitis

• ADESOS is a Phase 2b dose-finding study of orismilast modified release (MR) tablet in moderate to severe atopic dermatitis (AD) with the purpose of identifying the appropriate dose-regimen for Phase 3 studies
• AD is the most common chronic inflammatory skin disease in the developed world
• Orismilast is a next generation PDE4 inhibitor shown to be potent in inhibiting pathways important in AD
• Orismilast MR tablet is also in development for the treatment of psoriasis and hidradenitis suppurativa (HS)

Hellerup, Denmark, 4 August 2022 – UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, announces that the first patient has been enrolled in ADESOS, a Phase 2b dose-finding study evaluating the safety and efficacy of orismilast MR tablet in adult patients with moderate to severe AD. The purpose of the study is to identify the appropriate dose regimen for Phase 3 studies.

In November 2021, the US Food and Drug Administration (FDA) granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD. The FDA’s Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. This underscores the need for new treatment options with potential to fulfil the unmet medical needs for people affected by AD.

UNION has recently investigated the inhibitory effect of orismilast on the secretion of various inflammatory cytokines in human peripheral blood mononuclear cells in vitro. Orismilast underlined its potential in AD, psoriasis, and HS by demonstrating broad anti-inflammatory properties with potent inhibition of the main cytokines involved in these indications¹⁾. Data from the study will be presented at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-11 September 2022.

Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“Orismilast modified release tablet holds the potential to become a first-in-class treatment and become an efficacious treatment option for patients who need systemic therapy for atopic dermatitis. The initiation of the ADESOS study marks an important advancement of UNION’s pipeline.”

Jonathan Silverberg, MD, PhD, MPH, Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS adds: 
“AD is one of the most common chronic skin diseases worldwide. Despite recent advancements in the treatment of AD, there are still many unmet needs for safe and effective oral treatments. Orismilast modified release tablet has the potential to be an effective and patient-friendly treatment option in AD.”

About the ADESOS Phase 2b study
The Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate the efficacy and safety of orismilast MR tablet in patients with moderate to severe AD. The study will target 210 patients who will be randomized to three active doses (20mg, 30mg, and 40 mg) of orismilast relative to placebo administered twice daily. The study will be conducted in centers in Europe and the US.

About orismilast
UNION is developing orismilast, which is a potent next-generation phosphodiesterase type-4 (PDE4) inhibitor operating early in the inflammation cascade to induce a broad spectrum of downstream anti-inflammatory effects. Orismilast has the potential to inhibit many inflammatory pathways involved in dermatological and immunological diseases and holds potential to become a safe and efficacious treatment option in various dermatological and immunological diseases.

UNION has two product candidates with orismilast in its clinical stage pipeline: Orismilast MR tablet currently investigated for the treatment of psoriasis, AD and HS; and topical orismilast with clinical proof of concept established in AD. UNION is progressing orismilast as a modified release tablet to minimize the occurrence of gastrointestinal side effects typically associated with PDE4-inhibition.

In November 2020, the FDA cleared UNION’s Investigational New Drug (IND) application for orismilast MR tablet, and in November 2021, the FDA granted Fast Track designation to orismilast MR tablet for the treatment of moderate to severe AD.

In September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan²⁾. 

About atopic dermatitis
AD is a chronic inflammatory skin disease affecting approximately 3% of the adult population worldwide and is the most common skin disease among children, with the disease commonly occurring by five years of age³⁾. There was approximately 26 million diagnosed cases of AD in 2021 in the Seven Major Markets (US, France, Germany, Italy, Spain, UK, and Japan)⁴⁾. Disease symptoms are characterized by recurrent eczematous skin lesions and intense itch. AD has a substantial psychosocial impact on patients and relatives⁵⁾. During disease flares, approximately 80% of patients may experience disturbed sleep, which may also disrupt the sleep of family members⁶⁾. The disease also appears to impact the mood and patients have an increased risk of anxiety and depression⁷⁾.

Sources

1. In vitro study to assess the effect of orismilast on cytokine production in human PBMCs. Study number: DSK0001
2. https://uniontherapeutics.com/union-therapeutics-and-innovent-biologics-enter-into-strategic-collaboration-and-license-agreement-for-orismilast-a-next-generation-pde4-inhibitor-for-inflammatory-dermatology-conditions-1/
3. https://pubmed.ncbi.nlm.nih.gov/25925336/
4. Decision Resources Group (2020): Atopic Dermatitis – Disease Landscape & Forecast. Published November 12, 2020  
5. https://pubmed.ncbi.nlm.nih.gov/33006135/
6. https://pubmed.ncbi.nlm.nih.gov/24290431/
7. 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
stj@uniontherapeutics.com

About UNION therapeutics
UNION therapeutics is a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with multiple candidates in clinical development. 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