Hellerup, Denmark, February 12, 2025, – UNION therapeutics A/S (“UNION”), a privately held, clinical stage, pharmaceutical development company focused on immunology, announces full-year results for the period January 1 to December 31, 2024.
During 2024 we saw the promising results of orismilast in an additional indication, this time atopic dermatitis (AD), with another dataset indicating potency superior to previous generations of PDE4-inhibitors while retaining the well-established safety profile of the compound class, supporting the broad potential of orismilast.
The promise of orismilast as a potent PDE4B/D inhibitor continued to garner attention from medical leaders in the dermatological research community, with the initial results from the ADESOS Phase 2b study selected for late-breaking oral presentations at prominent scientific conferences, and the results from the OSIRIS Phase 2a study in hidradenitis suppurativa accepted for publication in the Journal of the European Academy of Dermatology and Venereology, a globally leading journal within dermatology.
The AD study concluded the extensive, multi-indication clinical development program that has been ongoing during the past years, with a corresponding reduction in the organization during 2024, adapting to the level of ongoing clinical development.
The company is now planning the next stage of development for orismilast, which includes shaping the clinical development and regulatory strategy. Focus is initially on hidradenitis suppurativa, a devastating inflammatory skin disease with very few treatment options available and no oral treatments approved, leaving a significant unmet medical need.
Additionally, the focus will be on securing the necessary financial resources for executing on the continued development of orismilast. The latter is of critical importance, particularly amid the ongoing challenges in the financial markets for smaller biotech companies, and has the undivided attention of the Board and Management in the coming year.
Kim Kjøller, Co-Chief Executive Officer of UNION therapeutics said:
“Across the indications we have tested orismilast in so far, I am pleased to see the higher potency consistently demonstrated as well as the confirmation of the well-established safety profile of the compound class. Following analysis of the clinical results and the commercial context, we expect to focus the efforts on hidradenitis suppurativa, where the mechanistic fit seems to be especially good, with indication of lesional efficacy at least on par with biologics as well as a unique early and strong effect on pain – the key symptom for HS patients. In addition, PDE4-inhibition is associated with benefits on metabolic syndrome and weight-loss, which is of particular importance in this indication, as it is directly addressing the most important co-morbidity of HS patients resulting in twofold excess cardiovascular morbidity. Collectively this gives orismilast a potential position in the treatment landscape unlike any other treatment candidate approved or currently in development.”
Financial results for the full year 2024
- Research and development costs of DKK 60.8m (2023: 140.3m; 2022: DKK 186.4m)
- Operating result for the year of DKK –87.7m (2023: -160.0m; 2022: DKK –183.6m)
- Cash and cash equivalents at year-end of DKK 37.6m (2023: 95.3m; 2022: DKK 159.0m)
Highlights for 2024
- Successful completion of the Phase 2b study ADESOS with orismilast in atopic dermatitis, the most prevalent inflammatory skin disease, and successful End-of-Phase 2 meeting with the U.S. Food & Drug Administration.
- Publication of results from the OSIRIS Phase 2 study of orismilast in hidradenitis suppurativa in the Journal of the European Academy of Dermatology and Venereology.
- Results of orismilast in atopic dermatitis selected for late-breaking oral presentations at leading scientific conferences Revolutionizing Alopecia Areata, Vitiligo, and Eczema (RAVE) and European Academy of Dermatology and Venerology (EADV).
- Patient enrollment progressed for the investigator-initiated Phase 2 study UCORIS with orismilast in ulcerative colitis (UC), a chronic inflammatory bowel disease.
- Dr. Peter Kristensen elected as new member of UNION’s Board of Directors, replacing Dr. Jutta Heim, bringing extensive clinical development expertise from 20+ years at Novo Nordisk including GLP-1 development programs.
UNION’s Annual Report for 2024
This announcement is a summary of UNION’s Annual Report for 2023, published on February 10, 2024. A PDF version of the Annual Report will be available for download here: Annual Report 2024
Contacts
Morten Boesen, Chief Financial Officer, UNION therapeutics A/S
+45 2381 5487
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 http://www.uniontherapeutics.com
