UNION therapeutics announces presentation of preliminary data from Phase 2a investigator-initiated study with orismilast in ulcerative colitis at the 20th ECCO Congress

• Poster presentation of preliminary data from the Phase 2a investigator-initiated study UCORIS in ulcerative colitis (UC) at the 20^th ECCO Congress
• UC is a chronic inflammatory bowel disease that causes inflammation and ulcers (sores) in the lower digestive tract with limited efficacious treatment options available
• Orismilast is a high-potency PDE4B/D inhibitor with broad anti-inflammatory properties in development for oral treatment of inflammatory diseases, including hidradenitis suppurative (HS)

HELLERUP, Denmark, Feb. 21, 2025 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately-held, clinical stage, pharmaceutical development company focused on immunology, today announced a poster presentation on new clinical data of oral orismilast in patients with UC at the 20^th European Crohn's and Colitis Organisation (ECCO) congress on February 19-22, 2025, in Berlin, Germany.

UCORIS is a Phase 2a, open-label, investigator-initiated study investigating the efficacy and safety of oral orismilast for up to 12 weeks in adult patients with moderate and severe UC. Following the inclusion of 10 patients, the enrollment for the study has stopped with the study expected to be completed in 2025. The preliminary data from the proof-of-concept study suggests that orismilast exhibits therapeutic potential in moderate-to-severe ulcerative colitis, with three patients achieving complete remission.

Poster details

Poster title: Orismilast for the Treatment of Moderate to Severe Ulcerative Colitis: A phase 2a, open-label, single-arm explorative clinical study

Authors: Trine Velte Honoré, Flemming Bendtsen, Jakob Seidelin, Johan Burisch

Kim Kjøller, Chief Executive Officer of UNION therapeutics said:
"We are encouraged by the investigators' presentation of preliminary data on orismilast for the treatment of ulcerative colitis at the ECCO congress. UC is a systemic autoimmune bowel disease where a high unmet medical need persists for effective and safe treatments."

About UC and treatment of UC

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes inflammation and ulcers (sores) in the lower digestive tract, i.e. colon and rectum. More than 1.8 million patients are diagnosed with UC in the US, Japan and EU5 and the incidence of UC is increasing worldwide¹⁾. Despite the treatment options available today, an unmet medical need for safe oral treatments with improved efficacy remains. UC is a disease that can be in remission (less active) for longer periods of time and then suddenly flare (termed "relapse"). During periods of relapse, patients experience a significant impact on their everyday lives, experiencing symptoms such as bloody stool, diarrhea, fecal incontinence, increased frequency of bowel movements (urgency), fatigue, and abdominal pain (cramps).

Depending on the severity of UC and patient preferences, the treatment is tailored accordingly. Patients with mild UC are often treated with mild anti-inflammatory medication, taken orally or rectally, such as aminosalicylates, corticosteroids or immunomodulators. Patients with moderate to severe UC are often treated with immunosuppressants, biologics or a combination of such treatments. Overall, treatments aim to induce a rapid clinical response and maintain remission, ideally healing the ulcers and preventing long-term disability.

About orismilast

UNION is developing orismilast, a high-potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. 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.²⁾

Orismilast holds the potential to become a safe and efficacious oral treatment for several immunological diseases³⁾, and UNION is currently developing oral orismilast for the treatment of hidradenitis suppurativa (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 HS as well as for the treatment of moderate to severe atopic dermatitis.

Sources

1. EvaluatePharma (2024).
2. 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
3. Warren R.B. et al., Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS), J Am Acad Dermatol 2024: https://pubmed.ncbi.nlm.nih.gov/37951245/ & Silverberg J.I. et al., Orismilast, a PDE4B/D inhibitor, in moderate-to-severe atopic dermatitis: Efficacy and safety from a multicenter, randomized, placebo-controlled, phase 2b dose-ranging study (ADESOS), Br J Dermatol 2025: https://pubmed.ncbi.nlm.nih.gov/39847538/. Frederiksen et al., JEADV 2023: https://pubmed.ncbi.nlm.nih.gov/38147438/.

Contacts
Morten Boesen, Chief Financial Officer, UNION therapeutics A/S
[phone]
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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 multiple marketed drugs. Read more at www.uniontherapeutics.com

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