- UCORIS is an investigator-initiated, Phase 2 study of orismilast for the treatment of moderate to severe ulcerative colitis (UC)
- UC is a chronic, inflammatory bowel disease with substantial unmet medical need for new oral treatments
- Orismilast is a next-generation, high potency PDE4 B/D selective inhibitor with recently reported positive Phase 2b results in psoriasis and Phase 2 results in hidradenitis suppurativa (HS); orismilast also recently completed enrollment in an ongoing Phase 2b study in atopic dermatitis
Hellerup, Denmark, January 4, 2024 – UNION therapeutics A/S (UNION), a privately-held, clinical stage, pharmaceutical development company focused on immunology, today announced the enrollment of the first patient in UCORIS, a Phase 2, open-label, investigator-led study of oral orismilast in adult patients with moderate to severe UC. The primary objective of UCORIS is to explore evidence of efficacy of orismilast in the treatment of patients with UC for 12 weeks.
Johan Burisch, MD, PhD, DMSc, Hvidovre hospital, signatory investigator of the UCORIS study said:
“UC is a chronic, inflammatory bowel disease greatly influencing the quality of life for patients. Despite the treatment options available today, an unmet medical need persists for treatment of moderate-to-severe UC, and especially for a safe oral treatment without screening and monitoring by the treating physician. We are therefore pleased to be able to enroll the first patients in this study and hope that orismilast as an innovative oral approach will demonstrate benefit in the management of this disease.”
Kim Kjøller, Chief Executive Officer of UNION therapeutics adds:
“Following positive Phase 2 data from two clinical trials with oral orismilast in psoriasis and HS – and data expected in atopic dermatitis in H1’24 – we were encouraged by thought leaders in Ulcerative Colitis to embark on demonstrating the potency of oral orismilast beyond the field of dermatology. The potent subtype specific PDE4 mechanism of orismilast alongside previous clinical data provides a strong rationale for testing the molecule in new indications such as inflammatory bowel disease to further broaden the ‘pipeline in a drug’ opportunity. We greatly appreciate the continued broad support from our shareholders allowing us to further advance and broaden our mid- to late-stage clinical pipeline with a hope to maximize impact of orismilast.”
About the UCORIS PoC study
UCORIS is a phase 2, open-label, two-center, prospective, single arm, investigator-initiated proof of concept study investigating the efficacy and safety of orismilast initially for 12 weeks with the possibility of extending treatment to 52 weeks in adult patients with moderate to severe UC. The clinically relevant primary endpoint is the proportion of patients with clinical remission on Total Mayo score at Week 12 of treatment.
About orismilast
Orismilast is a next generation, high potency PDE4 inhibitor targeting the PDE4B/D subtypes linked to inflammation, demonstrating potent inhibition of Th1, Th2 and Th17 pathways. It acts early in the inflammation cascade, inducing a broad range of anti-inflammatory effects across multiple cytokines involved in many dermatological and immunological diseases.1)
UNION is developing orismilast as an oral treatment, based on the well-known safety profile of the PDE4 class, across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis, hidradenitis suppurativa, psoriasis and ulcerative colitis.
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 the treatment of moderate to severe HS.
About UC
Ulcerative colitis (UC) is a chronic, inflammatory bowel disease (IBD) in which abnormal reactions of the immune system cause inflammation and ulcers on the inner lining of the large intestine. Patients experience times of remission when symptoms disappear for weeks or years, followed by relapse when symptoms return. During periods of relapse patients experience a significant impact on their everyday lives with e.g., blood in the stool, diarrhea, fecal incontinence, increased frequency of bowel movements, fatigue, and abdominal discomfort (cramps). Patients with UC might also experience symptoms and complications outside the colon e.g., eyes, skin, joints.2)
Different treatment options are used depending on the severity of the disease. Mild to moderate patients with UC are treated with amino salicylates, corticosteroids or immunomodulators to reduce inflammation. Patients with moderate to severe UC are often treated with immunosuppressants targeted small molecules (JAK inhibitors and S1P receptor modulators) or biologics (anti-TNFα, anti-IL23p19, anti-IL-12/23p40, anti-a4b7), or a combination of treatments. Patients with severe UC that do not respond to treatment, or if complications such as colon cancer develops, are referred to surgery. Despite the treatment options available today an unmet medical need persists for treatment of moderate-to-severe UC and especially for a safe oral treatment without screening and monitoring by the treating physician.3)
Sources
1) Blauvelt A et al., Dermatology and Therapy 2023: Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review – PubMed (nih.gov) &
Silverberg J.I. et al., JEADV 2022: https://onlinelibrary.wiley.com/doi/10.1111/jdv.18818 &
Warren R.B. et al., JEADV 2022: https://onlinelibrary.wiley.com/doi/10.1111/jdv.18812
2) Ungaro et al., Lancet 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487890/
3) Zurba et al., Biomedicines 2023: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10045261/ & Vieujean et al., Therapeutic Advances in Gastroenterology 2023: https://pubmed.ncbi.nlm.nih.gov/37197397/
Contacts
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. 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
