- Topline results expected in first half of 2023
- Orismilast is a potent next generation PDE4 inhibitor with broad anti-inflammatory properties also in development for the treatment of hidradenitis suppurativa (HS) and atopic dermatitis (AD)
Hellerup, Denmark, 11 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 it has completed enrollment of the last patient in IASOS, a Phase 2b dose-ranging study evaluating the safety and efficacy of orismilast MR (modified release) tablet in adult patients with moderate to severe psoriasis. The study is being conducted at clinical sites in the US, the UK, Germany, and Poland respectively. UNION expects to report topline data from this study in the first half of 2023.
Prof. Richard Warren, MD, PhD, The University of Manchester and Consultant Dermatologist, Salford Royal NHS Foundation Trust, Signatory Investigator of the Phase 2b study said:
“This is a major milestone for IASOS, which initiated late December 2021. To complete patient enrollment within this time frame is the result of diligent work by the trial investigators and the tremendous support and commitment from all patients, doctors and other health care workers involved in this study. Orismilast modified release holds significant promise as a new oral treatment for psoriasis with potential for high efficacy, long term use, and not requiring screening before initiation and during use.”
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“We are delighted to reach this significant milestone for orismilast modified release as we work diligently to provide a potential best-in-class treatment for patients with psoriasis. The fast speed of patient enrollment in the IASOS study is outstanding, underpinning the medical need for new improved oral treatments and importantly brings it one step closer to patients with psoriasis.”
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 orismilast MR tablet in adult patients with moderate to severe plaque psoriasis. The study targeted to include 200 patients randomized to three active doses and placebo administered twice daily.
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. Moreover, orismilast 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 US Food and Drug Administration (FDA) cleared UNION’s Investigational New Drug (IND) application for orismilast MR tablet in a Phase 2b trial in patients with moderate to severe psoriasis, 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 Taiwan1).
About psoriasis and treatment of psoriasis
Psoriasis is an autoimmune 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 can appear on any area of the body, but most often appears on the scalp, knees, elbows, trunk, and limbs, and the plaques are often itchy and sometimes painful.
Psoriasis can be managed by topical, oral, and biological treatments as well as phototherapy. Depending on the progression and severity of the disease, patients and physicians choose between these treatment options3). Patients with moderate to severe psoriasis often require treatment with systemic therapies which can be either oral medications or injectable biologics. There are a limited number of oral treatments available, and they generally have a less favorable effect relative to their safety and tolerability profile. The biologic treatments can be very effective, but their use is limited by their high cost, patient preference against injections, and requirements for the treating physician to screen patients and monitor for infections4).
2) US data: Armstrong et al. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. Published online June 30, 2021.
UK, Germany, France, Italy, Spain and Japan data: Decision Resources Group Psoriasis Report 2020
4) SERMO psoriasis unmet need survey 2021 (n=60)
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, 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 http://www.uniontherapeutics.com