UNION therapeutics announces presentation of new data on orismilast at the EADV Congress 2023

2023-10-06

临床2期快速通道

Late-breaking presentation of data from the OSIRIS IIT PoC study of oral orismilast in hidradenitis suppurativa (HS) at the European Academy of Dermatology and Venerology Congress 2023

Additional e-posters on the efficacy and safety of orismilast in moderate-to-severe psoriasis from the IASOS Phase 2b study and biomarker analyses from the skin of patients in the IASOS study, will be presented

Positive topline data from the IASOS study was reported early January 2023 and for the OSIRIS study in June 2023

Orismilast is a next generation high-potency PDE4B/D selective inhibitor with broad anti-inflammatory properties in development for oral treatment of atopic dermatitis (AD), HS and psoriasis

HELLERUP, Denmark, Oct. 6, 2023 /PRNewswire/ -- UNION therapeutics A/S (UNION), a privately held, multi-asset, clinical stage, pharmaceutical development company focused on immunology and infectious disease, today announced acceptance of a late-breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) Congress 2023 on October 11-14, 2023, in Berlin, Germany. New data from the OSIRIS investigator-initiated (IIT) proof of concept open label, single center study of oral orismilast in HS will be presented by the investigator Professor, Dr. Gregor Jemec.

Additionally, two e-posters from the IASOS Phase 2b study will be presented at the EADV Congress 2023, describing the clinical efficacy and safety of orismilast and its impact on biomarkers measured in the skin of moderate-to-severe psoriasis patients.

Oral presentation details

Presentation: A Phase 2a, open-label, single-center, single-arm, dose finding 16 weeks clinical trial of orismilast for the treatment of hidradenitis suppurativa

Presenter: Prof., Dr. Gregor Jemec, Founding Chairman of the Department of Dermatology, Zealand University Hospital, Denmark

Session code: D2T01.3I

Date and time: Thursday, October 12, 2023, at 16:30-16:45 CEST

E-poster details

Poster title: Molecular effects in the skin of psoriasis after oral treatment with orismilast

Authors: James G. Krueger, Richard B. Warren, Emma Guttman-Yassky

Poster ID: P2420

Poster title: Significant improvements in signs and symptoms with orismilast in moderate-to-severe psoriasis: Efficacy, safety and sub-analyses from the Phase 2b IASOS trial

Authors: Richard B. Warren, Lars E. French, Andrew Blauvelt

Poster ID: P2387

Professor Gregor B. Jemec, PhD, MD, Founding Chairman of the Department of Dermatology, Zealand University Hospital Roskilde, Denmark and sponsoring investigator of the study says:

"A strong unmet need remains for a safe and effective oral treatment for hidradenitis suppurativa. The promising topline results from the OSIRIS study illustrates that potent PDE4 inhibition by orismilast offers the potential for additional efficacy in combination with a well-known safety profile from the PDE4 class."

Kim Kjøller, Chief Executive Officer of UNION therapeutics adds:

"We are pleased that results from the OSIRIS IIT PoC study have been selected as a late-breaking presentation at the EADV Congress 2023. Additionally, we are super excited about presenting two posters with new data on orismilast at the Congress. The data presented at EADV demonstrate the attractive profile of orismilast and its potential to be a first or best-in-class candidate for the treatment of atopic dermatitis, hidradenitis suppurativa and psoriasis. We look forward to the results being shared and discussed with the leading experts in the field."

About orismilast

Orismilast is a next generation, high potency PDE4B/D selective inhibitor, selectively targeting the PDE4B/D subtypes linked to inflammation, leading to 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.1)

UNION is developing orismilast as an efficacious but safe oral treatment across immunology, initially targeting best-in-class or first-in-class positions in atopic dermatitis, hidradenitis suppurativa and psoriasis.

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. In 2021, UNION entered a strategic partnership with Innovent Biologics for the development of orismilast in Mainland China, Hong Kong, Macau, and Taiwan.

Sources

Silverberg J.I. et al., Pharmacology of orismilast, a potent and selective PDE4 inhibitor 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

Contacts

Morten Boesen, Chief Financial Officer, UNION therapeutics A/S

+45 2381 5487

[email protected]

Sarah Toft-Jørgensen, Director of Communications and IR, UNION therapeutics A/S

+45 5385 3044

[email protected]

About UNION therapeutics

UNION therapeutics is a privately held, mid- to late-stage, pharmaceutical development company advancing novel treatment options within immunology and infectious diseases, two large and fast-growing therapeutic areas. 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 www.uniontherapeutics.com

SOURCE UNION therapeutics