- Preclinical data presented in the oral presentation demonstrate that orismilast is a potent inhibitor of phosphodiesterase type-4 (PDE4), and that orismilast more selectively inhibit PDE4B and PDE4D subtypes which are considered more relevant in the treatment of immunological diseases
- Phase 2a data support development of orismilast modified release (MR) tablet to improve the tolerability of orismilast which had demonstrated proof of concept in moderate to severe psoriasis in an immediate release (IR) tablet
- Data presented at EADV support orismilast potential as a first-in-class or best-in-class treatment for certain immunological diseases
- UNION is currently developing orismilast MR tablet for the treatment of psoriasis, atopic dermatitis (AD) and hidradenitis suppurativa (HS)
Hellerup, Denmark, 8 September 2022 – UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious diseases, today presented new data on pharmacological properties of orismilast from its preclinical studies with orismilast as well as not previously presented Phase 2a data on the safety and efficacy of orismilast IR formulation at the 31st EADV (European Academy of Dermatology and Venereology) Congress at 7-10 September 2022 in Milan, Italy.
The preclinical results demonstrated that orismilast is a potent inhibitor of PDE4 subtypes involved in inflammatory signaling cascades associated with chronic inflammatory diseases. Orismilast more selectively inhibited PDE4B and PDE4D subtypes, which are believed to be most relevant for inflammation. Furthermore, orismilast inhibited the release of cytokines related to type 1, type 2 and type 17 pathways and general inflammation (e.g. TNFa, INFg, IL-1a, IL-4, IL-13 and IL-23) in human immune cells (PBMCs). Importantly, orismilast inhibited TNF-a release more potently than apremilast, the only approved oral PDE4 inhibitor in dermatology, in human whole-blood. Finally, orismilast demonstrated a comparable anti-inflammatory effect to dexamethasone in the oxazolone-induced ear inflammation mouse model.1)
The data was presented by J.I. Silverberg MD, PhD, MPH, Professor of Dermatology at George Washington University School of Medicine and Health Sciences and Signatory Investigator for ADESOS, Phase 2b dose finding study with orismilast MR tablet in AD. Please find a short summary of the presentation in the following video available at UNION’s website: https://uniontherapeutics.com/orismilast/
Moreover, Phase 2a data on orismilast IR tablets was presented at EADV as an e-poster. The Phase 2a data demonstrated the potential for differentiated efficacy profile of orismilast IR in patients with moderate to severe psoriasis. High rate of discontinuation due to gastrointestinal adverse events rates led to the development of the orismilast MR tablets. The improved tolerability of the orismilast MR tablet can potentially enable more patients to stay on treatment. This supports the potential of orismilast MR as a potential first-in-class and best-in-class treatment of psoriasis, AD and HS. 2)
Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
“We believe this encouraging new data on orismilast, a potent next-generation PDE4 inhibitor, presented at the EADV Congress, underscores the unique potential for orismilast as first-in-class or best-in-class treatment for psoriasis, atopic dermatitis, and hidradenitis suppurativa.”
UNION is developing orismilast, which is a next-generation PDE4 inhibitor with high potency for the PDE4 subtypes linked to inflammation. It operates early in the inflammation cascade to induce a broad range of 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 is currently developing orismilast MR tablet for the treatment of psoriasis, AD and HS. UNION is progressing orismilast as a MR 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. Moreover, in September 2021, UNION entered into a strategic partnership and licensing agreement with Innovent Biologic for orismilast in Mainland China, Hong Kong, Macau and Taiwan.
1) Silverberg J.I. et al. Pharmacology of orismilast, a next generation PDE4 inhibitor. Presented as oral presentation at EADV 2022, 7-10 September at Milan, Italy.
2) Warren RB et al. Oral orismilast: Efficacy and safety in moderate-severe psoriasis and development of modified release tablets. Presented as e-poster at EADV 2022, 7-10 September at Milan, Italy.
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