- Late-breaking presentation of results from the Phase 2b IASOS study of oral orismilast in psoriasis to be presented at the American Academy of Dermatology (AAD) Annual Meeting 2023
- Positive topline data from the IASOS study reported early January 2023, supporting the target product profile of oral orismilast as a best-in-class PDE4 inhibitor
- Orismilast is a high-potency PDE4 inhibitor with broad anti-inflammatory properties in development for oral treatment of atopic dermatitis (AD), psoriasis and hidradenitis suppurativa (HS)
Hellerup, Denmark, March 13, 2023 – UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced acceptance of a late-breaking oral presentation at the AAD Annual Meeting 2023 on March 17-21, 2023, in New Orleans, US. New data from the Phase 2b, randomized, dose-finding IASOS study, investigating the efficacy and safety of oral orismilast in adult patients with moderate to severe psoriasis will be presented by Professor Lars French.
Positive topline data from the IASOS study was reported on January 9, 2023, which supported the target product profile of a best-in-class PDE4 inhibitor and confirms the well-established, favorable safety profile of PDE4 inhibition.
Presentation: Efficacy and safety of orismilast in patients with moderate-to-severe psoriasis: Results from the Phase IIb IASOS trial
Presenter: Prof., Dr. Lars French, Department of Dermatology and Allergy, Ludwig-Maximilian University Hospital, Munich, Germany
Date and time: Saturday March 18, 2023, at 1:50pm CST / 7:50pm CET
Location: New Orleans Ernest N. Morial Convention Center Theater B
Prof. Richard Warren, MBChB (Hons), PhD, The University of Manchester and Consultant Dermatologist, Northern Care Alliance, Coordinating Investigator of the Phase 2b study said:
“A strong unmet need remains for oral medicines in psoriasis, as many patients are undertreated or are dissatisfied with current options. The promising topline data from the IASOS study illustrates that potent PDE4 inhibition by orismilast offers the potential for additional efficacy in combination with a well-known safety profile from the PDE4 class.”
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“We are pleased that Phase 2b results from the IASOS study have been selected among 250 submitted abstracts as late-breaking presentation at AAD Annual Meeting 2023. A large unmet need remains for more effective but safe oral treatments in psoriasis as well as more broadly in immune-driven diseases, and orismilast has demonstrated the potential to address this very need. We look forward to the results being shared and discussed with the leading experts in the field.”
About the IASOS Phase 2b study
The Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of oral orismilast in adult patients with moderate to severe plaque psoriasis. The study included 202 patients randomized to receive 1 of 3 active doses or placebo administered twice daily. The study was conducted at clinical sites in the US, the UK, Germany, and Poland.
UNION is developing orismilast, a high-potency PDE4 inhibitor targeting the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1)
Orismilast holds the potential to become a safe and efficacious oral treatment for many immunological diseases, and UNION is currently developing oral orismilast for the treatment of AD, psoriasis, and HS.
The FDA has cleared UNION’s Investigational New Drug (IND) application for oral orismilast and granted Fast Track designation for oral orismilast for the treatment of moderate to severe AD as well as for treatment of moderate to severe HS. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan.
About psoriasis and treatment of psoriasis
Psoriasis is a chronic, systemic, inflammatory skin disease that is diagnosed in an estimated 13 million patients in 2021 in the Seven Major Markets (US, UK, Germany, France, Italy, Spain and Japan)2). Plaque psoriasis is the most common type and can appear on any area of the body, but most often appears on the scalp, knees, elbows, trunk, and limbs. Patients with psoriasis experience substantial morbidity and increased rates of inflammatory arthritis, cardiometabolic diseases, and mental health disorders3).
Psoriasis can be managed by topical, oral, and biological treatments as well as phototherapy. Depending on the severity of the disease, patients and treatments are selected in a stepwise manner4). Patients with moderate to severe psoriasis often require treatment with systemic therapies which can be either oral medications or injectable biologics. Few oral treatments are available today and new drugs with improved efficacy and safety are needed. The biologic treatments can be very effective, but their use is limited by high costs, patient preference against injections, and requirements for monitoring by the treating physician.
1) Silverberg J.I. et al., Pharmacology of orismilast, a potent and selective PDE4 inhibitor, JEADV 2022: https://onlinelibrary.wiley.com/doi/10.1111/jdv.18818 & Warren R.B. et al., Efficacy and safety in moderate-severe psoriasis and development of modified release tablets, JEADV 2022: https://onlinelibrary.wiley.com/doi/10.1111/jdv.18812
2) US data: Armstrong et al. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021: https://pubmed.ncbi.nlm.nih.gov/34190957/
UK, Germany, France, Italy, Spain and Japan data: Decision Resources Group Psoriasis Report 2020.
3) Armstrong AW and Read C. Pathophysiology, Clinical Presentation, and Treatment of Psoriasis: A Review. JAMA 2020: https://pubmed.ncbi.nlm.nih.gov/32427307/
4) Nast A. et al. EuroGuiDerm guideline for the systemic treatment of psoriasis vulgaris, February 2022: https://guidelines.edf.one/guidelines/psoriasis-guideline
Morten Boesen, Chief Financial Officer, UNION therapeutics A/S
+45 2381 5487
Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S
+45 5385 3044
About UNION therapeutics
UNION therapeutics is a privately held, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. 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 http://www.uniontherapeutics.com